A Phase 3 interventional study of PF-04965842 100 mg and PF-04965842 200 mg in Dermatitis, Atopic, sponsored by Pfizer. Completed at 88 sites in 8 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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Among 20 studies testing abrocitinib in Dermatitis, Atopic — 5 open to participants now, 5 under way, 2 of them phase 3. abrocitinib · Dermatitis, Atopic.
Among the 20 studies testing abrocitinib in Dermatitis, Atopic, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 10 in phase 3, and was the 2nd registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
Browse Dermatitis, Atopic studies →5 of the 20 studies testing abrocitinib in Dermatitis, Atopic are open now, in 7 countries. Recruiting first, the newest first:
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 12+
Pfizer · Sites in United States, China, Hungary and 4 more countries
Ages 2–11
Pfizer
Ages 2–5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+
By country, each count listing its studies:
abrocitinib: first FDA approval 2022 (CIBINQO), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 387 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 150 across the 20 interventional studies. Of the 15 that completed or were terminated, 11 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 20 have an industry lead sponsor. The 5 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
58 studies in Dermatitis, Atopic by Pfizer: 11 open now, 13 under way, 4 of them phase 3. Of 43 finished, 34 (79%) have results posted.
Among the 58 studies in Dermatitis, Atopic by Pfizer, this one is the 13th largest by enrollment of the 47 interventional ones that give a count, is one of 3 that started in 2017, is one of 17 in phase 3, and was the 13th registered.
Pfizer’s Dermatitis, Atopic studies by the year they started, since 2009.
1 of the studies testing abrocitinib in Dermatitis, Atopic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07848074Fondazione Policlinico Universitario Agostino Gemelli IRCCSAbrocitinib Dose Tapering in Patients With Atopic Dermatitis | 2027-05-01 |
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Among the 20 studies testing abrocitinib in Dermatitis, Atopic, from their registry updates:
Among Pfizer’s 58 in Dermatitis, Atopic:
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B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: PF-04965842 100 mg
Drug: PF-04965842 200 mg
Drug: Placebo
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time frame: Baseline, Week 12
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 12
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time frame: Baseline, Week 2, 4, 12
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time frame: Baseline, Week 12
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus
Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.
Time frame: Baseline up to Week 12
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time frame: Baseline, Week 2, 4, 8
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time frame: Week 2, 4, 8, 12
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time frame: Week 2, 4, 8, 12
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12
POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12
Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Time frame: Baseline, Week 2, 4, 8, 12
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12
Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12
EQ-5D-5L: standardized participant (aged \>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12
EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12
EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12
FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
Time frame: Baseline, Week 12
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
Time frame: Baseline, Week 12
Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary
SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
Time frame: Baseline, Week 12
Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary
SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
Time frame: Baseline, Week 12
Plasma Concentration Versus Time Summary of PF-04965842
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.
Time frame: Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose
Participants with age greater than or equal to (\>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of \>=40 kilogram were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.
| Milestone | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Started | 156 | 154 | 77 |
| Completed | 135 | 137 | 61 |
| Not completed | 21 | 17 | 16 |
| Withdrew: Adverse event | 9 | 9 | 7 |
| Withdrew: Lack of efficacy | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Protocol violation | 2 | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 3 | 4 |
| Withdrew: Medication error,no linked adverse event | 0 | 0 | 1 |
| Withdrew: Withdrawal by parent/guardian | 0 | 1 | 0 |
| Withdrew: Other | 2 | 1 | 0 |
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12 | 23.7 | 43.8 | 7.9 |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12 | 39.7 | 62.7 | 11.8 |
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 20.4 | 45.6 | 2.7 |
| Week 4 | 32.2 | 58.8 | 17.2 |
| Week 8 | 34.3 | 59.9 | 14.4 |
| Week 12 | 37.7 | 57.2 | 15.3 |
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 20.5 | 47.6 | 3.7 |
| Week 4 | 34.0 | 63.3 | 20.7 |
| Week 12 | 41.1 | 60.6 | 12.3 |
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -1.5 (-1.7 to -1.2) | -2.1 (-2.3 to -1.8) | -0.5 (-0.8 to -0.1) |
| Change at Week 4 | -1.8 (-2.1 to -1.5) | -3.0 (-3.2 to -2.7) | -0.7 (-1.1 to -0.3) |
| Change at Week 8 | -2.2 (-2.5 to -1.8) | -3.1 (-3.5 to -2.8) | -1.2 (-1.7 to -0.7) |
| Change at Week 12 | -2.2 (-2.6 to -1.9) | -3.2 (-3.6 to -2.8) | -1.1 (-1.7 to -0.6) |
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set | -2.4 (-2.8 to -2.1) | -3.4 (-3.8 to -3.0) | -1.1 (-1.7 to -0.5) |
Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.
| days | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus | 84.0 (56.0 to NA) | 14.0 (11.0 to 29.0) | 92.0 (85.0 to NA) |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 10.3 | 24.0 | 3.9 |
| Week 4 | 27.6 | 47.4 | 14.5 |
| Week 8 | 38.3 | 57.8 | 13.3 |
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 3.9 | 9.7 | 0 |
| Week 4 | 10.5 | 27.0 | 5.3 |
| Week 8 | 20.3 | 35.7 | 6.7 |
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 0 | 0 | 0 |
| Week 4 | 0 | 6.6 | 0 |
| Week 8 | 4.6 | 11.7 | 0 |
| Week 12 | 7.1 | 13.1 | 0 |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 34.2 | 55.2 | 10.4 |
| Week 4 | 54.6 | 73.7 | 21.1 |
| Week 8 | 57.8 | 76.6 | 24.0 |
| Week 12 | 57.7 | 75.8 | 22.4 |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 1.9 | 5.2 | 1.3 |
| Week 4 | 7.9 | 24.3 | 3.9 |
| Week 8 | 14.3 | 33.1 | 5.3 |
| Week 12 | 18.6 | 38.6 | 5.3 |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 0 | 0 | 0 |
| Week 4 | 0 | 6.6 | 0 |
| Week 8 | 4.5 | 11.7 | 0 |
| Week 12 | 6.4 | 13.1 | 0 |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -9.8 (-11.3 to -8.4) | -14.7 (-16.1 to -13.3) | -4.1 (-6.1 to -2.1) |
| Change at Week 4 | -14.7 (-16.3 to -13.1) | -19.6 (-21.2 to -17.9) | -6.8 (-9.2 to -4.5) |
| Change at Week 8 | -16.3 (-18.1 to -14.6) | -21.3 (-23.0 to -19.5) | -7.8 (-10.3 to -5.3) |
| Change at Week 12 | -16.6 (-18.4 to -14.7) | -22.3 (-24.1 to -20.4) | -8.2 (-10.9 to -5.5) |
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
| Percentage BSA | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -11.8 (-14.3 to -9.4) | -18.8 (-21.3 to -16.4) | -4.0 (-7.6 to -0.5) |
| Change at Week 4 | -20.2 (-23.0 to -17.4) | -27.0 (-29.8 to -24.2) | -8.5 (-12.5 to -4.5) |
| Change at Week 8 | -23.2 (-26.3 to -20.2) | -31.5 (-34.6 to -28.5) | -8.9 (-13.3 to -4.5) |
| Change at Week 12 | -25.1 (-28.3 to -22.0) | -33.4 (-36.6 to -30.3) | -11.4 (-16.0 to -6.8) |
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 2.6 | 5.2 | 1.3 |
| Week 4 | 8.6 | 27.6 | 3.9 |
| Week 8 | 16.2 | 33.1 | 6.7 |
| Week 12 | 21.2 | 38.6 | 5.3 |
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 14.9 | 34.0 | 4.0 |
| Week 4 | 34.5 | 50.7 | 12.9 |
| Week 8 | 36.3 | 54.1 | 12.5 |
| Week 12 | 36.6 | 56.8 | 16.4 |
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 1.4 | 6.0 | 0 |
| Week 4 | 2.8 | 18.2 | 2.9 |
| Week 8 | 12.3 | 23.6 | 1.4 |
| Week 12 | 12.4 | 30.8 | 4.1 |
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -2.1 (-2.4 to -1.7) | -3.1 (-3.5 to -2.8) | -0.8 (-1.3 to -0.3) |
| Change at Week 4 | -2.5 (-2.9 to -2.1) | -3.7 (-4.1 to -3.3) | -1.0 (-1.5 to -0.4) |
| Change at Week 8 | -2.8 (-3.2 to -2.4) | -3.8 (-4.2 to -3.4) | -1.3 (-1.9 to -0.7) |
| Change at Week 12 | -2.9 (-3.4 to -2.5) | -3.7 (-4.2 to -3.3) | -1.6 (-2.2 to -1.0) |
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -16.4 (-18.7 to -14.2) | -24.4 (-26.7 to -22.2) | -5.5 (-8.7 to -2.4) |
| Change at Week 4 | -23.1 (-25.8 to -20.4) | -32.6 (-35.3 to -29.9) | -10.5 (-14.4 to -6.7) |
| Change at Week 8 | -26.0 (-29.1 to -23.0) | -33.7 (-36.7 to -30.7) | -11.7 (-16.0 to -7.4) |
| Change at Week 12 | -27.0 (-30.2 to -23.7) | -35.5 (-38.7 to -32.3) | -13.6 (-18.3 to -9.0) |
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 51.1 | 68.9 | 28.4 |
| Week 4 | 62.7 | 77.3 | 44.8 |
| Week 8 | 60.9 | 69.1 | 44.8 |
| Week 12 | 61.4 | 70.3 | 40.9 |
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -5.9 (-6.9 to -5.0) | -7.6 (-8.6 to -6.7) | -2.1 (-3.5 to -0.8) |
| Change at Week 4 | -6.8 (-7.8 to -5.9) | -9.6 (-10.6 to -8.7) | -3.5 (-4.9 to -2.1) |
| Change at Week 8 | -6.8 (-7.9 to -5.6) | -9.3 (-10.5 to -8.2) | -4.0 (-5.6 to -2.3) |
| Change at Week 12 | -7.0 (-8.1 to -5.8) | -9.1 (-10.3 to -8.0) | -4.2 (-5.9 to -2.5) |
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -4.5 (-5.8 to -3.2) | -5.8 (-7.1 to -4.5) | -3.3 (-5.1 to -1.4) |
| Change at Week 4 | -5.3 (-6.7 to -4.0) | -8.2 (-9.5 to -6.8) | -1.8 (-3.8 to 0.2) |
| Change at Week 8 | -5.2 (-6.9 to -3.6) | -7.5 (-9.2 to -5.9) | -3.1 (-5.6 to -0.6) |
| Change at Week 12 | -6.4 (-7.9 to -5.0) | -7.5 (-8.9 to -6.0) | -3.9 (-6.1 to -1.7) |
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 10.0 | 23.5 | 3.4 |
| Week 4 | 15.3 | 32.5 | 8.5 |
| Week 8 | 17.8 | 35.3 | 8.8 |
| Week 12 | 20.2 | 31.9 | 12.1 |
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 3.2 | 0 | 0 |
| Week 4 | 13.3 | 9.7 | 0 |
| Week 8 | 12.9 | 12.9 | 7.1 |
| Week 12 | 19.4 | 9.7 | 0 |
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 67.5 | 71.8 | 35.7 |
| Week 4 | 72.2 | 85.2 | 51.8 |
| Week 8 | 64.7 | 82.1 | 48.1 |
| Week 12 | 67.2 | 72.6 | 43.6 |
CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 73.3 | 74.2 | 56.3 |
| Week 4 | 69.0 | 83.9 | 40.0 |
| Week 8 | 66.7 | 77.4 | 35.7 |
| Week 12 | 73.3 | 83.9 | 53.3 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -0.7 (-1.0 to -0.3) | -1.3 (-1.6 to -0.9) | -0.2 (-0.7 to 0.3) |
| Change at Week 4 | -1.1 (-1.6 to -0.7) | -1.7 (-2.1 to -1.3) | 0.1 (-0.5 to 0.7) |
| Change at Week 8 | -1.0 (-1.4 to -0.6) | -2.0 (-2.4 to -1.6) | -0.3 (-0.9 to 0.3) |
| Change at Week 12 | -1.4 (-1.8 to -0.9) | -1.8 (-2.2 to -1.4) | -0.2 (-0.8 to 0.4) |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -1.1 (-1.5 to -0.7) | -1.7 (-2.0 to -1.3) | -0.9 (-1.5 to -0.4) |
| Change at Week 4 | -1.4 (-1.9 to -1.0) | -2.2 (-2.6 to -1.8) | -1.0 (-1.6 to -0.4) |
| Change at Week 8 | -1.5 (-1.9 to -1.0) | -2.3 (-2.7 to -1.8) | -1.0 (-1.7 to -0.4) |
| Change at Week 12 | -1.6 (-2.0 to -1.1) | -2.1 (-2.5 to -1.6) | -1.0 (-1.7 to -0.4) |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 48.5 | 64.7 | 38.9 |
| Week 4 | 50.0 | 54.5 | 55.6 |
| Week 8 | 42.4 | 58.8 | 22.2 |
| Week 12 | 39.4 | 48.5 | 38.9 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 45.5 | 60.0 | 22.2 |
| Week 4 | 68.2 | 68.4 | 55.6 |
| Week 8 | 57.1 | 70.0 | 66.7 |
| Week 12 | 50.0 | 75.0 | 33.3 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 56.3 | 46.2 | 75.0 |
| Week 4 | 56.3 | 58.3 | 75.0 |
| Week 8 | 56.3 | 53.8 | 75.0 |
| Week 12 | 43.8 | 46.2 | 37.5 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 20.0 | 75.0 | 100.0 |
| Week 4 | 60.0 | 75.0 | 66.7 |
| Week 8 | 40.0 | 75.0 | 66.7 |
| Week 12 | 40.0 | 75.0 | 66.7 |
POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -4.6 (-5.5 to -3.7) | -8.1 (-9.0 to -7.2) | -1.8 (-3.1 to -0.5) |
| Change at Week 4 | -6.2 (-7.2 to -5.1) | -10.8 (-11.8 to -9.8) | -2.4 (-3.9 to -0.9) |
| Change at Week 8 | -6.1 (-7.3 to -4.9) | -10.6 (-11.8 to -9.5) | -3.4 (-5.1 to -1.7) |
| Change at Week 12 | -6.8 (-8.0 to -5.6) | -10.6 (-11.8 to -9.4) | -3.7 (-5.5 to -1.9) |
Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | -0.6 (-0.8 to -0.5) | -1.1 (-1.2 to -0.9) | -0.3 (-0.5 to -0.1) |
| Change at Week 4 | -0.8 (-1.0 to -0.7) | -1.3 (-1.5 to -1.2) | -0.4 (-0.6 to -0.1) |
| Change at Week 8 | -1.0 (-1.1 to -0.8) | -1.4 (-1.6 to -1.2) | -0.5 (-0.7 to -0.2) |
| Change at Week 12 | -1.0 (-1.2 to -0.9) | -1.5 (-1.7 to -1.3) | -0.5 (-0.8 to -0.3) |
Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
| percentage of participants | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Week 2 | 7.2 | 19.2 | 1.3 |
| Week 4 | 14.6 | 31.5 | 5.4 |
| Week 8 | 17.2 | 34.4 | 8.5 |
| Week 12 | 21.1 | 36.0 | 6.8 |
EQ-5D-5L: standardized participant (aged \>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | 0.049 (0.030 to 0.068) | 0.084 (0.065 to 0.103) | 0.016 (-0.011 to 0.043) |
| Change at Week 4 | 0.062 (0.041 to 0.084) | 0.092 (0.070 to 0.114) | 0.037 (0.007 to 0.067) |
| Change at Week 8 | 0.053 (0.029 to 0.077) | 0.097 (0.074 to 0.121) | 0.005 (-0.029 to 0.039) |
| Change at Week 12 | 0.058 (0.034 to 0.083) | 0.078 (0.054 to 0.103) | 0.014 (-0.021 to 0.050) |
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | 5.586 (3.203 to 7.969) | 9.697 (7.294 to 12.100) | 1.038 (-2.361 to 4.437) |
| Change at Week 4 | 6.207 (3.473 to 8.940) | 11.931 (9.174 to 14.688) | 1.846 (-2.005 to 5.696) |
| Change at Week 8 | 6.982 (3.847 to 10.117) | 10.740 (7.642 to 13.838) | 0.937 (-3.528 to 5.402) |
| Change at Week 12 | 8.604 (5.509 to 11.699) | 10.409 (7.328 to 13.489) | -1.035 (-3.451 to 5.520) |
EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | 0.115 (0.039 to 0.191) | 0.209 (0.134 to 0.284) | 0.119 (0.009 to 0.228) |
| Change at Week 4 | 0.168 (0.071 to 0.265) | 0.278 (0.183 to 0.374) | -0.006 (-0.149 to 0.137) |
| Change at Week 8 | 0.122 (0.017 to 0.228) | 0.198 (0.093 to 0.304) | 0.118 (-0.040 to 0.275) |
| Change at Week 12 | 0.160 (0.056 to 0.265) | 0.215 (0.109 to 0.322) | 0.153 (-0.007 to 0.314) |
EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change at Week 2 | 5.515 (0.318 to 10.712) | 14.933 (9.742 to 20.124) | 3.384 (-4.217 to 10.985) |
| Change at Week 4 | 5.359 (-0.339 to 11.057) | 15.496 (9.803 to 21.188) | -1.494 (-10.060 to 7.072) |
| Change at Week 8 | 11.828 (5.736 to 17.919) | 12.510 (6.345 to 18.674) | 3.156 (-6.213 to 12.524) |
| Change at Week 12 | 10.347 (5.347 to 15.347) | 17.224 (12.151 to 22.297) | 4.276 (-3.397 to 11.948) |
FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12 | 2.4 (0.8 to 3.9) | 3.3 (1.7 to 4.8) | -1.3 (-3.6 to 1.0) |
Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 | 2.2 (0.5 to 3.9) | 2.1 (0.3 to 3.8) | 1.2 (-1.4 to 3.9) |
SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary | 4.3 (3.0 to 5.6) | 5.2 (3.9 to 6.5) | 0.5 (-1.4 to 2.4) |
SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.
| units on a scale | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary | 1.5 (-0.1 to 3.0) | 2.8 (1.3 to 4.3) | -0.2 (-2.5 to 2.0) |
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.
| ng/mL | PF-04965842 100 mg | PF-04965842 200 mg |
|---|---|---|
| Week 4: 0 Hour | 14.57 ± 65.044 | 58.16 ± 162.11 |
| Week 4: 0.5 Hour post dose | 485.3 ± 393.36 | 889.7 ± 786.96 |
| Week 12: 0.5 Hour Post-dose | 440.6 ± 373.81 | 933.9 ± 741.09 |
| Week 12: 4 Hour Post-dose | 273.1 ± 176.37 | 838.9 ± 544.29 |
Collected over Baseline up to Week 16. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-04965842 100 mg | 0/156 (0%) | 5/156 (3.2%) | 65/156 (41.7%) |
| PF-04965842 200 mg | 0/154 (0%) | 5/154 (3.2%) | 65/154 (42.2%) |
| Placebo | 0/77 (0%) | 3/77 (3.9%) | 26/77 (33.8%) |
| Event | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| AppendicitisInfections and infestations | 1/156 | 0/154 | 1/77 |
| Meniscal degenerationMusculoskeletal and connective tissue disorders | 0/156 | 0/154 | 1/77 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/156 | 2/154 | 0/77 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 0/156 | 0/154 | 1/77 |
| Inflammatory bowel diseaseGastrointestinal disorders | 0/156 | 1/154 | 0/77 |
| PeritonsillitisInfections and infestations | 0/156 | 1/154 | 0/77 |
| DehydrationMetabolism and nutrition disorders | 0/156 | 1/154 | 0/77 |
| Retinal detachmentEye disorders | 1/156 | 0/154 | 0/77 |
| Pancreatitis acuteGastrointestinal disorders | 1/156 | 0/154 | 0/77 |
| DizzinessNervous system disorders | 1/156 | 0/154 | 0/77 |
| Event | PF-04965842 100 mg | PF-04965842 200 mg | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 14/156 | 31/154 | 2/77 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 22/156 | 8/154 | 13/77 |
| NasopharyngitisInfections and infestations | 23/156 | 18/154 | 8/77 |
| HeadacheNervous system disorders | 12/156 | 15/154 | 2/77 |
| Upper respiratory tract infectionInfections and infestations | 11/156 | 11/154 | 5/77 |
The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.
| Age, Continuous(years) | PF-04965842 100 mg | PF-04965842 200 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 32.6 ± 15.4 | 33.0 ± 17.4 | 31.5 ± 14.4 | 32.5 ± 16.0 |
| Sex: Female, Male(Participants) | PF-04965842 100 mg | PF-04965842 200 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 66 | 73 | 28 | 167 |
| Male | 90 | 81 | 49 | 220 |
| Ethnicity (NIH/OMB)(Participants) | PF-04965842 100 mg | PF-04965842 200 mg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 6 | 20 |
| Not Hispanic or Latino | 144 | 149 | 71 | 364 |
| Unknown or Not Reported | 2 | 1 | 0 | 3 |
| Race (NIH/OMB)(Participants) | PF-04965842 100 mg | PF-04965842 200 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 4 | 1 | 6 |
| Asian | 26 | 26 | 6 | 58 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 15 | 11 | 6 | 32 |
| White | 113 | 104 | 62 | 279 |
| More than one race | 1 | 6 | 1 | 8 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Dec 2017 to primary completion in Mar 2019, 15 months.
Results were first posted in Dec 2019, 8 months after primary completion.
Of 149 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 28. This study's 15 months is below that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abrocitinib