A Phase 3 interventional study of PF-04965842 100 mg and PF-04965842 200 mg in Dermatitis, Dermatitis, Atopic and Eczema, sponsored by Pfizer. Completed at 216 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.
This study's enrollment of 838 is above the median of 68 across 191 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Female subjects who are of must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20
Drug: PF-04965842 100 mg · Drug: Injectable Placebo
Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20
Drug: PF-04965842 200 mg · Drug: Injectable Placebo
Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20
Drug: Dupilumab · Drug: Oral Placebo
Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20
Drug: PF-04965842 100 mg · Drug: Oral Placebo · Drug: Injectable Placebo
Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20
Drug: PF-04965842 200 mg · Drug: Oral Placebo · Drug: Injectable Placebo
PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.
PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.
Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: 1. In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20; 2. In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.
Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12
IGA assessed severity of atopic dermatitis (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 scalp, palms and sole.
Time frame: Baseline (the last measurement prior to first dosing on Day 1), Week 12
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12
EASI evaluates severity of participants with 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 in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16
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, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16
IGA assessed 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 and 16
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
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 and 16
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 and 16
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 and 16
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 and 16
Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS
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 up to Week 16
Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16
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 and 16
Percentage BSA at Week 18 and 20
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: Week 18 and 20
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16
Participant responded to the following question: "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 and 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16
DLQI is a 10-item questionnaire that measures the impact of skin disease. 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, 12 and 16
DLQI at Week 20
DLQI is a 10-item questionnaire that measures the impact of skin disease. 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: Week 20
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16
EQ-5D-5L: standardized participant 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 12 and 16
Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16
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 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 12 and 16
EQ-5D-5L- Index Value at Week 20
EQ-5D-5L: standardized participant 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: Week 20
EQ-5D-5L- VAS Score at Week 20
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 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: Week 20
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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, Weeks 12 and 16
Change From Baseline in HADS - Depression Scale at Week 12 and 16
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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 12 and 16
HADS - Anxiety Scale at Week 20
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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: Week 20
HADS - Depression Scale at Week 20
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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: Week 20
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16
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 following: "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 12 and 16
POEM at Week 20
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 following: "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: Week 20
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16
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 1 to Week 16
PSAAD Total Score at Week 18 and 20
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: Week 18 and 20
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
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 and 16
Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16
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 and 16
Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16
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 and 16
SCORAD VAS of Itch and Sleep Loss at Week 18 and 20
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: Week 18 and 20
Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16
Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.
Time frame: Baseline up to Week 16
| Milestone | Placebo up to Week 16 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|---|
| Started | 131 | 0 | 0 | 238 | 226 | 243 |
| Treated/ safety analysis set | 131 | 0 | 0 | 238 | 226 | 242 |
| Full analysis set | 131 | 0 | 0 | 238 | 226 | 242 |
| Completed | 117 | 0 | 0 | 217 | 208 | 223 |
| Not completed | 14 | 0 | 0 | 21 | 18 | 20 |
| Withdrew: Adverse event | 5 | 0 | 0 | 5 | 8 | 6 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 2 | 1 | 2 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Protocol deviation | 2 | 0 | 0 | 2 | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 0 | 0 | 9 | 3 | 6 |
| Withdrew: Medication error without associated adverse event | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 1 | 2 | 2 |
| Withdrew: Randomized but not treated | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | Placebo up to Week 16 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|---|
| Started | 0 | 60 | 57 | 217 | 208 | 223 |
| Treated/ safety analysis set | 0 | 60 | 57 | 217 | 208 | 223 |
| Full analysis set | 0 | 60 | 57 | 217 | 208 | 223 |
| Completed | 0 | 58 | 55 | 210 | 204 | 218 |
| Not completed | 0 | 2 | 2 | 7 | 4 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 2 | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol deviation | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 2 | 2 | 2 |
| Withdrew: Other | 0 | 1 | 0 | 2 | 1 | 0 |
IGA assessed severity of atopic dermatitis (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 scalp, palms and sole.
| Percentage of participants | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 | 14.0 (8.0 to 19.9) | 36.6 (30.4 to 42.8) | 48.4 (41.8 to 55.0) | 36.5 (30.4 to 42.6) |
EASI evaluates severity of participants with 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | 27.1 (19.5 to 34.8) | 58.7 (52.4 to 65.0) | 70.3 (64.3 to 76.4) | 58.1 (51.9 to 64.3) |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Day 2 | 5.1 (1.1 to 9.1) | 5.9 (2.8 to 9.0) | 7.4 (3.8 to 11.0) | 2.4 (0.3 to 4.5) |
| Day 3 | 7.9 (2.9 to 12.8) | 8.4 (4.7 to 12.1) | 14.8 (9.9 to 19.7) | 3.3 (0.9 to 5.7) |
| Day 4 | 6.0 (1.7 to 10.4) | 11.6 (7.3 to 15.8) | 18.6 (13.2 to 24.0) | 5.6 (2.5 to 8.6) |
| Day 5 | 7.6 (2.8 to 12.3) | 14.2 (9.5 to 18.9) | 26.5 (20.3 to 32.7) | 9.5 (5.6 to 13.5) |
| Day 6 | 10.9 (5.3 to 16.5) | 15.0 (10.2 to 19.8) | 25.1 (19.2 to 31.0) | 14.0 (9.4 to 18.7) |
| Day 7 | 11.1 (5.2 to 17.0) | 20.1 (14.7 to 25.5) | 28.8 (22.7 to 35.0) | 13.4 (8.9 to 18.0) |
| Day 8 | 14.4 (8.1 to 20.7) | 21.4 (15.9 to 27.0) | 33.3 (26.9 to 39.8) | 16.5 (11.5 to 21.5) |
| Day 9 | 13.0 (6.9 to 19.2) | 24.0 (18.2 to 29.9) | 34.1 (27.7 to 40.6) | 14.8 (10.0 to 19.7) |
| Day 10 | 13.2 (7.0 to 19.4) | 25.6 (19.6 to 31.6) | 34.3 (27.8 to 40.8) | 17.1 (12.0 to 22.2) |
| Day 11 | 12.7 (6.7 to 18.7) | 25.4 (19.4 to 31.4) | 39.5 (32.9 to 46.1) | 20.5 (15.0 to 25.9) |
| Day 12 | 12.0 (6.1 to 17.8) | 25.5 (19.5 to 31.5) | 44.1 (37.2 to 50.9) | 21.9 (16.3 to 27.4) |
| Day 13 | 13.2 (7.0 to 19.4) | 30.6 (24.2 to 37.1) | 43.8 (37.0 to 50.7) | 23.6 (17.9 to 29.3) |
| Day 14 | 15.7 (9.2 to 22.2) | 31.4 (25.1 to 37.7) | 45.7 (38.8 to 52.7) | 24.5 (18.7 to 30.3) |
| Day 15 | 11.1 (5.4 to 16.8) | 30.4 (24.2 to 36.7) | 49.0 (42.2 to 55.8) | 26.5 (20.6 to 32.5) |
| Week 2 | 13.8 (7.9 to 19.8) | 31.8 (25.8 to 37.7) | 49.1 (42.6 to 55.6) | 26.4 (20.8 to 31.9) |
| Week 4 | 20.2 (13.1 to 27.2) | 44.6 (38.1 to 51.2) | 59.3 (52.8 to 65.9) | 45.3 (38.9 to 51.7) |
| Week 8 | 27.0 (19.2 to 34.9) | 47.5 (40.9 to 54.1) | 64.0 (57.6 to 70.4) | 50.7 (44.2 to 57.1) |
| Week 12 | 28.9 (20.8 to 37.0) | 47.5 (40.9 to 54.1) | 63.1 (56.7 to 69.6) | 54.5 (47.9 to 61.0) |
| Week 16 | 28.7 (19.6 to 37.9) | 47.0 (39.5 to 54.6) | 62.8 (55.6 to 70.0) | 57.1 (50.1 to 64.2) |
IGA assessed 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 6.3 (2.1 to 10.4) | 15.2 (10.6 to 19.9) | 18.4 (13.3 to 23.5) | 4.7 (2.0 to 7.4) |
| Week 4 | 6.2 (2.0 to 10.4) | 25.2 (19.6 to 30.8) | 31.4 (25.3 to 37.5) | 18.9 (13.9 to 23.9) |
| Week 8 | 10.1 (4.9 to 15.3) | 35.8 (29.6 to 41.9) | 50.7 (44.1 to 57.2) | 28.5 (22.7 to 34.2) |
| Week 16 | 12.9 (7.0 to 18.8) | 34.8 (28.6 to 40.9) | 47.5 (40.9 to 54.1) | 38.8 (32.5 to 45.1) |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 10.9 (5.5 to 16.3) | 25.4 (19.8 to 31.1) | 30.0 (24.0 to 36.1) | 14.0 (9.6 to 18.5) |
| Week 4 | 15.6 (9.3 to 21.9) | 44.6 (38.3 to 51.0) | 57.4 (50.9 to 63.9) | 38.2 (32.1 to 44.4) |
| Week 8 | 18.6 (11.9 to 25.3) | 55.6 (49.2 to 62.0) | 67.9 (61.7 to 74.0) | 52.7 (46.4 to 59.0) |
| Week 16 | 30.6 (22.5 to 38.8) | 60.3 (53.9 to 66.6) | 71.0 (65.1 to 77.0) | 65.5 (59.4 to 71.6) |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 21.9 (14.7 to 29.0) | 53.1 (46.6 to 59.5) | 60.5 (54.1 to 67.0) | 35.7 (29.6 to 41.9) |
| Week 4 | 39.8 (31.4 to 48.3) | 73.4 (67.7 to 79.1) | 78.5 (73.1 to 83.9) | 66.8 (60.8 to 72.8) |
| Week 8 | 48.8 (40.2 to 57.5) | 78.9 (73.6 to 84.1) | 88.4 (84.2 to 92.6) | 77.4 (72.1 to 82.7) |
| Week 12 | 52.7 (44.1 to 61.3) | 75.3 (69.8 to 80.8) | 86.3 (81.7 to 90.9) | 80.9 (76.0 to 85.9) |
| Week 16 | 57.3 (48.6 to 66.0) | 81.2 (76.2 to 86.3) | 87.3 (82.9 to 91.7) | 84.1 (79.3 to 88.8) |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 2.3 (0.0 to 5.0) | 8.3 (4.7 to 11.9) | 11.2 (7.1 to 15.4) | 2.6 (0.5 to 4.6) |
| Week 4 | 6.3 (2.1 to 10.4) | 20.2 (15.0 to 25.3) | 32.3 (26.2 to 38.4) | 12.2 (8.0 to 16.3) |
| Week 8 | 7.8 (3.1 to 12.4) | 30.6 (24.7 to 36.5) | 47.3 (40.8 to 53.9) | 24.3 (18.8 to 29.7) |
| Week 12 | 10.1 (4.9 to 15.3) | 36.6 (30.4 to 42.8) | 46.1 (39.5 to 52.7) | 34.9 (28.8 to 40.9) |
| Week 16 | 11.3 (5.7 to 16.9) | 38.0 (31.7 to 44.3) | 48.9 (42.3 to 55.5) | 38.8 (32.5 to 45.1) |
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 0 (0.0 to 2.8) | 1.3 (0.0 to 2.8) | 4.5 (1.8 to 7.2) | 0.4 (0.0 to 1.3) |
| Week 4 | 0 (0.0 to 2.8) | 2.6 (0.5 to 4.6) | 7.2 (3.8 to 10.6) | 2.5 (0.5 to 4.5) |
| Week 8 | 0 (0.0 to 2.8) | 6.0 (3.0 to 9.1) | 11.6 (7.4 to 15.8) | 2.1 (0.3 to 3.9) |
| Week 12 | 1.6 (0.0 to 3.7) | 8.1 (4.6 to 11.6) | 12.3 (8.0 to 16.7) | 6.6 (3.5 to 9.8) |
| Week 16 | 4.0 (0.6 to 7.5) | 12.7 (8.4 to 17.0) | 13.6 (9.1 to 18.1) | 5.2 (2.3 to 8.0) |
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.
| Days | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | NA (84.0 to NA) | 29.0 (16.0 to 56.0) | 13.0 (10.0 to 16.0) | 31.0 (29.0 to 57.0) |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 2 | -7.6 (-10.4 to -4.8) | -19.5 (-21.6 to -17.4) | -21.4 (-23.5 to -19.3) | -14.0 (-16.1 to -11.9) |
| Change at Week 4 | -14.3 (-17.2 to -11.4) | -26.8 (-29.0 to -24.7) | -30.7 (-32.9 to -28.4) | -24.0 (-26.2 to -21.9) |
| Change at Week 8 | -16.2 (-19.0 to -13.4) | -30.3 (-32.4 to -28.2) | -36.4 (-38.6 to -34.3) | -29.8 (-31.8 to -27.7) |
| Change at Week 12 | -17.1 (-20.1 to -14.1) | -31.6 (-33.8 to -29.4) | -37.4 (-39.6 to -35.1) | -32.5 (-34.7 to -30.3) |
| Change at Week 16 | -19.6 (-22.6 to -16.6) | -32.9 (-35.1 to -30.7) | -39.0 (-41.3 to -36.8) | -34.4 (-36.6 to -32.2) |
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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| Week 18 | 22.0 ± 23.67 | 20.8 ± 22.7 | 14.8 ± 19.3 | 9.8 ± 13.6 | 13.2 ± 16.4 |
| Week 20 | 18.0 ± 21.2 | 16.0 ± 19.7 | 14.2 ± 19.0 | 10.3 ± 14.2 | 13.2 ± 16.3 |
Participant responded to the following question: "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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 2 | -0.5 (-0.6 to -0.3) | -0.8 (-0.9 to -0.7) | -1.0 (-1.1 to -0.9) | -0.7 (-0.8 to -0.6) |
| Change at Week 4 | -0.5 (-0.7 to -0.4) | -1.0 (-1.1 to -0.9) | -1.4 (-1.5 to -1.3) | -1.1 (-1.2 to -0.9) |
| Change at Week 8 | -0.6 (-0.7 to -0.4) | -1.1 (-1.3 to -1.0) | -1.5 (-1.6 to -1.4) | -1.3 (-1.4 to -1.1) |
| Change at Week 12 | -0.7 (-0.8 to -0.5) | -1.2 (-1.3 to -1.1) | -1.6 (-1.7 to -1.5) | -1.3 (-1.4 to -1.2) |
| Change at Week 16 | -0.7 (-0.9 to -0.6) | -1.2 (-1.3 to -1.0) | -1.6 (-1.7 to -1.5) | -1.4 (-1.5 to -1.2) |
DLQI is a 10-item questionnaire that measures the impact of skin disease. 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 2 | -4.5 (-5.5 to -3.5) | -6.7 (-7.5 to -6.0) | -8.5 (-9.2 to -7.8) | -6.7 (-7.4 to -5.9) |
| Change at Week 12 | -6.2 (-7.1 to -5.3) | -8.7 (-9.4 to -8.0) | -11.0 (-11.7 to -10.3) | -9.9 (-10.6 to -9.2) |
| Change at Week 16 | -6.2 (-7.1 to -5.3) | -9.0 (-9.7 to -8.4) | -11.7 (-12.4 to -11.1) | -10.8 (-11.4 to -10.1) |
DLQI is a 10-item questionnaire that measures the impact of skin disease. 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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| DLQI at Week 20 | 5.3 ± 5.3 | 5.8 ± 5.7 | 6.3 ± 5.8 | 4.3 ± 4.7 | 5.6 ± 4.8 |
EQ-5D-5L: standardized participant 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 12 | 0.051 (0.032 to 0.070) | 0.101 (0.087 to 0.115) | 0.127 (0.113 to 0.141) | 0.104 (0.091 to 0.118) |
| Change at Week 16 | 0.067 (0.047 to 0.087) | 0.093 (0.079 to 0.107) | 0.133 (0.119 to 0.148) | 0.113 (0.099 to 0.127) |
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 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 12 | 7.975 (5.161 to 10.789) | 11.337 (9.272 to 13.401) | 17.373 (15.270 to 19.476) | 14.939 (12.900 to 16.978) |
| Change at Week 16 | 7.840 (4.952 to 10.727) | 11.223 (9.129 to 13.318) | 16.711 (14.581 to 18.841) | 14.405 (12.315 to 16.496) |
EQ-5D-5L: standardized participant 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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| EQ-5D-5L- Index Value at Week 20 | 0.905 ± 0.097 | 0.894 ± 0.122 | 0.883 ± 0.124 | 0.917 ± 0.109 | 0.890 ± 0.109 |
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 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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| EQ-5D-5L- VAS Score at Week 20 | 78.2 ± 16.3 | 78.5 ± 20.2 | 76.7 ± 19.5 | 82.1 ± 17.1 | 79.6 ± 18.0 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 12 | -0.4 (-0.9 to 0.1) | -1.2 (-1.5 to -0.8) | -1.6 (-2.0 to -1.2) | -1.4 (-1.7 to -1.0) |
| Change at Week 16 | -0.4 (-0.9 to 0.1) | -1.2 (-1.6 to -0.8) | -2.0 (-2.4 to -1.6) | -1.5 (-1.9 to -1.1) |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 12 | -0.3 (-0.7 to 0.2) | -1.3 (-1.6 to -0.9) | -1.6 (-1.9 to -1.2) | -1.3 (-1.6 to -0.9) |
| Change at Week 16 | -0.3 (-0.8 to 0.2) | -1.0 (-1.4 to -0.7) | -1.6 (-1.9 to -1.2) | -1.2 (-1.5 to -0.8) |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| HADS - Anxiety Scale at Week 20 | 3.4 ± 3.2 | 4.5 ± 4.5 | 4.0 ± 3.8 | 3.1 ± 3.1 | 3.7 ± 3.5 |
HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| HADS - Depression Scale at Week 20 | 2.6 ± 3.4 | 3.6 ± 3.7 | 2.8 ± 3.2 | 2.2 ± 3.1 | 2.7 ± 3.3 |
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 following: "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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 12 | -5.1 (-6.3 to -3.9) | -9.6 (-10.5 to -8.6) | -12.6 (-13.6 to -11.7) | -10.8 (-11.7 to -9.9) |
| Change at Week 16 | -5.0 (-6.3 to -3.8) | -9.2 (-10.1 to -8.2) | -12.5 (-13.4 to -11.6) | -10.8 (-11.8 to -9.9) |
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 following: "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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| POEM at Week 20 | 10.7 ± 6.8 | 9.6 ± 7.8 | 11.6 ± 7.7 | 8.6 ± 7.0 | 11.0 ± 6.9 |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Change at Week 1 | -0.5 (-0.8 to -0.3) | -1.1 (-1.3 to -0.9) | -1.3 (-1.5 to -1.2) | -0.9 (-1.1 to -0.8) |
| Change at Week 2 | -0.9 (-1.2 to -0.7) | -1.8 (-2.0 to -1.6) | -2.3 (-2.5 to -2.1) | -1.6 (-1.8 to -1.4) |
| Change at Week 3 | -1.1 (-1.4 to -0.8) | -2.2 (-2.4 to -2.0) | -2.8 (-3.0 to -2.6) | -2.1 (-2.3 to -1.9) |
| Change at Week 4 | -1.4 (-1.7 to -1.1) | -2.4 (-2.6 to -2.2) | -3.0 (-3.3 to -2.8) | -2.4 (-2.7 to -2.2) |
| Change at Week 5 | -1.5 (-1.8 to -1.2) | -2.6 (-2.8 to -2.4) | -3.2 (-3.5 to -3.0) | -2.7 (-2.9 to -2.5) |
| Change at Week 6 | -1.5 (-1.8 to -1.2) | -2.6 (-2.8 to -2.4) | -3.3 (-3.6 to -3.1) | -2.8 (-3.1 to -2.6) |
| Change at Week 7 | -1.6 (-1.9 to -1.2) | -2.7 (-2.9 to -2.4) | -3.4 (-3.6 to -3.1) | -2.9 (-3.2 to -2.7) |
| Change at Week 8 | -1.5 (-1.9 to -1.2) | -2.7 (-2.9 to -2.4) | -3.4 (-3.7 to -3.2) | -3.0 (-3.2 to -2.7) |
| Change at Week 9 | -1.7 (-2.0 to -1.4) | -2.7 (-2.9 to -2.4) | -3.5 (-3.8 to -3.3) | -3.1 (-3.3 to -2.8) |
| Change at Week 10 | -1.7 (-2.0 to -1.4) | -2.7 (-2.9 to -2.4) | -3.5 (-3.8 to -3.3) | -3.1 (-3.4 to -2.9) |
| Change at Week 11 | -1.6 (-1.9 to -1.3) | -2.7 (-2.9 to -2.4) | -3.5 (-3.8 to -3.3) | -3.2 (-3.4 to -2.9) |
| Change at Week 12 | -1.6 (-2.0 to -1.3) | -2.7 (-3.0 to -2.5) | -3.6 (-3.8 to -3.3) | -3.2 (-3.5 to -3.0) |
| Change at Week 13 | -1.7 (-2.0 to -1.4) | -2.8 (-3.1 to -2.6) | -3.7 (-3.9 to -3.4) | -3.3 (-3.6 to -3.1) |
| Change at Week 14 | -1.6 (-1.9 to -1.3) | -2.8 (-3.1 to -2.6) | -3.6 (-3.9 to -3.4) | -3.4 (-3.6 to -3.2) |
| Change at Week 15 | -1.7 (-2.0 to -1.4) | -2.9 (-3.1 to -2.6) | -3.6 (-3.8 to -3.4) | -3.4 (-3.6 to -3.1) |
| Change at Week 16 | -1.7 (-2.0 to -1.3) | -2.8 (-3.1 to -2.6) | -3.6 (-3.8 to -3.4) | -3.4 (-3.6 to -3.2) |
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 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| Week 18 | 2.6 ± 1.9 | 3.0 ± 2.4 | 2.2 ± 1.9 | 1.7 ± 1.7 | 1.8 ± 1.5 |
| Week 20 | 2.5 ± 2.0 | 2.6 ± 2.3 | 2.2 ± 1.9 | 1.8 ± 1.8 | 2.0 ± 1.6 |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 10.2 (4.9 to 15.4) | 23.6 (18.2 to 29.1) | 38.4 (32.0 to 44.8) | 15.6 (11.0 to 20.2) |
| Week 4 | 18.6 (11.9 to 25.3) | 45.7 (39.3 to 52.1) | 61.6 (55.2 to 68.0) | 45.8 (39.5 to 52.1) |
| Week 8 | 20.2 (13.2 to 27.1) | 53.4 (47.0 to 59.8) | 71.6 (65.7 to 77.5) | 56.9 (50.6 to 63.2) |
| Week 12 | 27.3 (19.6 to 35.1) | 56.8 (50.5 to 63.2) | 72.3 (66.5 to 78.2) | 64.3 (58.2 to 70.4) |
| Week 16 | 33.3 (25.0 to 41.7) | 56.1 (49.7 to 62.6) | 68.8 (62.7 to 74.9) | 67.5 (61.5 to 73.6) |
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 | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Week 2 | 1.6 (0.0 to 3.7) | 6.4 (3.3 to 9.6) | 8.5 (4.8 to 12.1) | 0.8 (0.0 to 2.0) |
| Week 4 | 3.1 (0.1 to 6.1) | 12.4 (8.2 to 16.6) | 25.4 (19.7 to 31.2) | 7.1 (3.9 to 10.4) |
| Week 8 | 3.1 (0.1 to 6.1) | 19.2 (14.2 to 24.3) | 41.3 (34.9 to 47.8) | 16.3 (11.6 to 21.0) |
| Week 12 | 6.3 (2.1 to 10.4) | 25.6 (20.0 to 31.2) | 39.3 (32.9 to 45.7) | 26.1 (20.5 to 31.6) |
| Week 16 | 10.6 (5.1 to 16.0) | 26.8 (21.0 to 32.5) | 40.3 (33.8 to 46.7) | 29.4 (23.6 to 35.3) |
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.
| units on a scale | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Itch: Change at Week 2 | -1.5 (-1.9 to -1.2) | -2.9 (-3.2 to -2.7) | -3.7 (-4.0 to -3.4) | -2.4 (-2.7 to -2.1) |
| Itch: Change at Week 4 | -2.2 (-2.6 to -1.8) | -3.7 (-4.0 to -3.4) | -4.6 (-4.9 to -4.3) | -3.7 (-4.0 to -3.4) |
| Itch: Change at Week 8 | -2.3 (-2.7 to -1.9) | -3.9 (-4.2 to -3.6) | -4.9 (-5.2 to -4.6) | -4.2 (-4.5 to -3.9) |
| Itch: Change at Week 12 | -2.4 (-2.9 to -2.0) | -3.9 (-4.3 to -3.6) | -5.0 (-5.3 to -4.7) | -4.4 (-4.7 to -4.1) |
| Itch: Change at Week 16 | -2.7 (-3.1 to -2.3) | -3.8 (-4.1 to -3.5) | -4.8 (-5.1 to -4.5) | -4.5 (-4.8 to -4.2) |
| Sleep loss: Change at Week 2 | -1.6 (-2.0 to -1.2) | -2.6 (-2.9 to -2.3) | -3.3 (-3.6 to -3.0) | -2.3 (-2.6 to -1.9) |
| Sleep loss: Change at Week 4 | -2.3 (-2.7 to -1.9) | -3.4 (-3.7 to -3.1) | -4.2 (-4.5 to -3.9) | -3.4 (-3.7 to -3.1) |
| Sleep loss: Change at Week 8 | -2.3 (-2.7 to -1.9) | -3.6 (-3.9 to -3.3) | -4.4 (-4.7 to -4.1) | -3.9 (-4.2 to -3.6) |
| Sleep loss: Change at Week 12 | -2.4 (-2.8 to -2.0) | -3.7 (-4.0 to -3.4) | -4.6 (-4.9 to -4.3) | -4.2 (-4.5 to -3.9) |
| Sleep loss: Change at Week 16 | -2.6 (-3.0 to -2.2) | -3.7 (-4.0 to -3.4) | -4.8 (-5.1 to -4.5) | -4.3 (-4.6 to -4.0) |
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,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.
| units on a scale | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|
| Itch: Week 18 | 3.2 ± 2.6 | 2.7 ± 2.2 | 3.0 ± 2.5 | 2.3 ± 2.2 | 2.7 ± 2.2 |
| Itch: Week 20 | 2.9 ± 2.4 | 2.6 ± 2.4 | 3.2 ± 2.6 | 2.3 ± 2.3 | 2.8 ± 2.2 |
| Sleep loss: Week 18 | 2.2 ± 2.3 | 2.3 ± 2.3 | 2.1 ± 2.3 | 1.6 ± 2.1 | 1.8 ± 2.0 |
| Sleep loss: Week 20 | 2.1 ± 2.2 | 2.0 ± 2.3 | 2.4 ± 2.6 | 1.5 ± 2.1 | 1.7 ± 2.1 |
Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.
| Days | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 |
|---|---|---|---|---|
| Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | 21.8 (14.9 to 28.8) | 30.2 (25.1 to 35.4) | 33.6 (28.3 to 38.9) | 28.1 (23.0 to 33.2) |
Collected over For reporting arms till Week 16 analysis: Baseline up to Week 16; For reporting arms post Week 16 analysis: Week 16 to Week 24 (28 days after last dose of study drug). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo up to Week 16 | 0/131 (0%) | 5/131 (3.8%) | 68/131 (51.9%) |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | 0/238 (0%) | 6/238 (2.5%) | 121/238 (50.8%) |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | 0/226 (0%) | 2/226 (0.9%) | 140/226 (61.9%) |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | 0/242 (0%) | 2/242 (0.8%) | 120/242 (49.6%) |
| Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | 0/60 (0%) | 0/60 (0%) | 13/60 (21.7%) |
| Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | 0/57 (0%) | 0/57 (0%) | 16/57 (28.1%) |
| PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | 0/217 (0%) | 1/217 (0.5%) | 50/217 (23%) |
| PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | 0/208 (0%) | 0/208 (0%) | 45/208 (21.6%) |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | 0/223 (0%) | 1/223 (0.4%) | 31/223 (13.9%) |
| Event | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| ChillsGeneral disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| PyrexiaGeneral disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Anaphylactic reactionImmune system disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Aspartate aminotransferase increasedInvestigations | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Breast massReproductive system and breast disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Night sweatsSkin and subcutaneous tissue disorders | 1/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 0/217 | 0/208 | 0/223 |
| Enteritis infectiousInfections and infestations | 0/131 | 0/238 | 0/226 | 0/242 | 0/60 | 0/57 | 1/217 | 0/208 | 0/223 |
| Event | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 |
|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 2/131 | 10/238 | 25/226 | 7/242 | 0/60 | 5/57 | 0/217 | 0/208 | 0/223 |
| NasopharyngitisInfections and infestations | 9/131 | 22/238 | 15/226 | 23/242 | 3/60 | 2/57 | 3/217 | 9/208 | 5/223 |
| HeadacheNervous system disorders | 6/131 | 10/238 | 15/226 | 13/242 | 1/60 | 1/57 | 2/217 | 0/208 | 2/223 |
| AcneSkin and subcutaneous tissue disorders | 0/131 | 7/238 | 15/226 | 3/242 | 1/60 | 0/57 | 2/217 | 0/208 | 0/223 |
| ConjunctivitisInfections and infestations | 3/131 | 2/238 | 3/226 | 15/242 | 0/60 | 0/57 | 0/217 | 0/208 | 2/223 |
| Upper respiratory tract infectionInfections and infestations | 6/131 | 12/238 | 9/226 | 9/242 | 1/60 | 0/57 | 6/217 | 5/208 | 7/223 |
| Back painMusculoskeletal and connective tissue disorders | 5/131 | 0/238 | 1/226 | 7/242 | 0/60 | 0/57 | 1/217 | 0/208 | 1/223 |
| Herpes simplexInfections and infestations | 1/131 | 5/238 | 8/226 | 2/242 | 0/60 | 0/57 | 1/217 | 4/208 | 1/223 |
| DiarrhoeaGastrointestinal disorders | 4/131 | 4/238 | 4/226 | 3/242 | 0/60 | 2/57 | 3/217 | 1/208 | 0/223 |
| Urinary tract infectionInfections and infestations | 2/131 | 4/238 | 7/226 | 4/242 | 2/60 | 0/57 | 2/217 | 0/208 | 1/223 |
Safety analysis set included all randomized participants who received at least 1 dose of study medication.
| Age, Categorical(Participants) | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 121 | 224 | 211 | 227 | 783 |
| >=65 years | 10 | 14 | 15 | 15 | 54 |
| Sex: Female, Male(Participants) | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Total |
|---|---|---|---|---|---|
| Female | 54 | 118 | 122 | 134 | 428 |
| Male | 77 | 120 | 104 | 108 | 409 |
| Ethnicity (NIH/OMB)(Participants) | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 16 | 35 | 36 | 37 | 124 |
| Not Hispanic or Latino | 113 | 200 | 187 | 201 | 701 |
| Unknown or Not Reported | 2 | 3 | 3 | 4 | 12 |
| Race (NIH/OMB)(Participants) | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 2 | 5 |
| Asian | 31 | 48 | 53 | 46 | 178 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | 0 | 2 |
| Black or African American | 6 | 6 | 9 | 14 | 35 |
| White | 87 | 182 | 161 | 176 | 606 |
| More than one race | 1 | 1 | 1 | 2 | 5 |
| Unknown or Not Reported | 3 | 0 | 1 | 2 | 6 |
Showing the first 100 of 216 sites across 18 countries. Choose a country and city above to see the rest.
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
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Abrocitinib