A Phase 3 interventional study of Baricitinib and Placebo in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 185 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies testing baricitinib in Dermatitis, Atopic — 1 open to participants now, 1 under way, none of them phase 3. baricitinib · Dermatitis, Atopic.
Among the 11 studies testing baricitinib in Dermatitis, Atopic, this one has the largest enrollment, is one of 5 that started in 2018, is one of 8 in phase 3, and was the 2nd registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →1 of the 11 studies testing baricitinib in Dermatitis, Atopic is open now, in 1 country. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12–120
By country, each count listing its studies:
baricitinib: first FDA approval 2018 (OLUMIANT), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 18 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.
11 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 5 started in 2018.
This study's enrollment of 1,645 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 440 across the 11 interventional studies. Of the 10 that completed or were terminated, 9 (90%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 11 have an industry lead sponsor. The 3 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
30 studies in Dermatitis, Atopic by Eli Lilly and Company: 1 open now, 2 under way, 2 of them phase 3. Of 28 finished, 25 (89%) have results posted.
Among the 30 studies in Dermatitis, Atopic by Eli Lilly and Company, this one has the largest enrollment, is one of 7 that started in 2018, is one of 21 in phase 3, and was the 3rd registered.
Eli Lilly and Company’s Dermatitis, Atopic studies by the year they started, since 2013.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing baricitinib in Dermatitis, Atopic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 30 in Dermatitis, Atopic:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:
Exclusion Criteria:
OR
Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
Inclusion Criteria:
Exclusion Criteria:
Have been treated with the following therapies:
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.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Responders or partial responders (RPR) \[Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
Drug: Baricitinib · Drug: Placebo
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
Drug: Baricitinib
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
Non-responder (NR) \[those not meeting definition of RPR\] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib · Drug: Placebo
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib · Drug: Placebo
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
Drug: Placebo
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
Drug: Baricitinib
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
Drug: Baricitinib
Administered orally
Also known as: LY3009104
Administered orally
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 16, 36 and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 16, 36, and 52
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 16, 36 and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 16, 36, 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 16, 36, and 52 Weeks
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Time frame: Week 16
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Weeks 68, 104
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Weeks 68, 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Time frame: Weeks 68, 104
Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated
Time frame: Week 52 Up to Week 200
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Weeks 68, 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Weeks 68, 104
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: Weeks 68, 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Week 68
Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Week 68
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Week 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Time frame: Week 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 104
Participants who entered Study JAHN were classified as "Responders and Partial Responders (RPR): Investigator's Global Assessment (IGA) of (0, 1, or 2) at entry to study JAHN and never rescued in originating study" or "Non-responders (NR): those not meeting definition of RPR". The study has two treatment periods: Treatment period 1, from Week 0 up to Week 52, and Treatment period 2, from Week 52 through Week 200 which included randomized withdrawal and downtitration substudy (RWDT).
| Milestone | Placebo | Baricitinib (Bari) 1- Milligram (mg) | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | 2 mg Bari to Placebo Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to 4 mg Bari Substudy | Placebo to Placebo Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 4 mg Bari to 4 mg Bari Non-substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 91 | 45 | 519 | 743 | 247 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Received at least 1 dose of investigational product (ip) | 91 | 45 | 519 | 743 | 247 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rpr | 91 | 45 | 108 | 134 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nr | 0 | 0 | 411 | 609 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 2 | 2 | 12 | 15 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 89 | 43 | 507 | 728 | 242 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Ongoing as of week 52 (later participants were moved to treatment period 2 [week 52 to 200]) | 70 | 32 | 379 | 519 | 146 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 3 | 5 | 76 | 140 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 2 | 1 | 9 | 23 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 11 | 4 | 38 | 42 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 1 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | Baricitinib (Bari) 1- Milligram (mg) | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | 2 mg Bari to Placebo Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to 4 mg Bari Substudy | Placebo to Placebo Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 4 mg Bari to 4 mg Bari Non-substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 92 | 91 | 92 | 84 | 84 | 84 | 70 | 32 | 249 | 264 |
| Received at least 1 dose of ip | 0 | 0 | 0 | 0 | 0 | 92 | 91 | 92 | 84 | 84 | 84 | 70 | 32 | 249 | 264 |
| Completed | 0 | 0 | 0 | 0 | 0 | 29 | 40 | 38 | 34 | 40 | 35 | 28 | 23 | 60 | 68 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 63 | 51 | 54 | 50 | 44 | 49 | 42 | 9 | 189 | 196 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 17 | 21 | 17 | 19 | 15 | 17 | 16 | 3 | 66 | 70 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 13 | 10 | 11 | 7 | 12 | 8 | 7 | 2 | 63 | 72 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 23 | 15 | 20 | 17 | 10 | 11 | 8 | 0 | 41 | 32 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 2 | 2 | 3 | 9 | 3 | 2 | 11 | 13 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 1 | 1 | 1 | 0 | 4 | 4 |
| Withdrew: Withdrawal due to caregiver circumstances | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Physician is retiring | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 2 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Sponsor decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 3 | 1 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | RPR-Placebo | RPR-Bari 1-mg | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|---|
| Week 16 | 36.5 (24.8 to 50.1) | 46.7 (32.9 to 60.9) | 59.3 (46.0 to 71.3) | 48.6 (37.2 to 60.0) |
| Week 36 | 23.1 (13.7 to 36.1) | 31.1 (19.5 to 45.7) | 63.0 (49.6 to 74.6) | 37.1 (26.8 to 48.9) |
| Week 52 | 28.8 (18.3 to 42.3) | 35.6 (23.2 to 50.2) | 50.0 (37.1 to 62.9) | 40.0 (29.3 to 51.7) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | RPR-Placebo | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|
| Week 16 | 47.1 (31.5 to 63.3) | 45.3 (32.7 to 58.5) | 31.7 (21.6 to 44.0) |
| Week 36 | 41.2 (26.4 to 57.8) | 24.5 (14.9 to 37.6) | 30.2 (20.2 to 42.4) |
| Week 52 | 29.4 (16.8 to 46.2) | 30.2 (19.5 to 43.5) | 31.7 (21.6 to 44.0) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | RPR-Placebo | RPR-Bari 1-mg | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|---|
| Week 16 | 69.2 (55.7 to 80.1) | 77.8 (63.7 to 87.5) | 81.5 (69.2 to 89.6) | 72.9 (61.5 to 81.9) |
| Week 36 | 48.1 (35.1 to 61.3) | 60.0 (45.5 to 73.0) | 81.5 (69.2 to 89.6) | 58.6 (46.9 to 69.4) |
| Week 52 | 46.2 (33.3 to 59.5) | 53.3 (39.1 to 67.1) | 72.2 (59.1 to 82.4) | 58.6 (46.9 to 69.4) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | RPR Placebo | RPR Bari 2 mg | RPR Bari 4 mg |
|---|---|---|---|
| Week 16 | 70.6 (53.8 to 83.2) | 73.6 (60.4 to 83.6) | 63.5 (51.1 to 74.3) |
| Week 36 | 55.9 (39.5 to 71.1) | 49.1 (36.1 to 62.1) | 52.4 (40.3 to 64.2) |
| Week 52 | 50.0 (34.1 to 65.9) | 54.7 (41.5 to 67.3) | 52.4 (40.3 to 64.2) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | NR: Bari 1 mg to 2 mg | NR: Bari 1 mg to 4 mg | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|---|---|
| Week 16 | 46.0 (35.9 to 56.4) | 55.6 (44.7 to 65.9) | 47.6 (37.3 to 58.2) | 43.6 (33.1 to 54.6) | 40.4 (33.0 to 48.2) |
| Week 36 | 40.2 (30.6 to 50.7) | 43.2 (33.0 to 54.1) | 44.0 (33.9 to 54.7) | 48.7 (37.9 to 59.6) | 39.1 (31.8 to 46.9) |
| Week 52 | 31.0 (22.3 to 41.4) | 48.1 (37.6 to 58.9) | 44.0 (33.9 to 54.7) | 38.5 (28.4 to 49.6) | 41.0 (33.6 to 48.9) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|
| Week 16 | 35.0 (18.1 to 56.7) | 57.1 (36.5 to 75.5) | 30.8 (18.6 to 46.4) |
| Week 36 | 40.0 (21.9 to 61.3) | 42.9 (24.5 to 63.5) | 20.5 (10.8 to 35.5) |
| Week 52 | 45.0 (25.8 to 65.8) | 42.9 (24.5 to 63.5) | 28.2 (16.5 to 43.8) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | NR: Bari 1 mg to 2 mg | NR: Bari 1 mg to 4 mg | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|---|---|
| Week 16 | 13.8 (8.1 to 22.6) | 23.5 (15.6 to 33.8) | 15.5 (9.3 to 24.7) | 17.9 (11.0 to 27.9) | 10.3 (6.4 to 16.0) |
| Week 36 | 13.8 (8.1 to 22.6) | 12.3 (6.8 to 21.3) | 10.7 (5.7 to 19.1) | 16.7 (10.0 to 26.5) | 16.7 (11.6 to 23.3) |
| Week 52 | 12.6 (7.2 to 21.2) | 12.3 (6.8 to 21.3) | 19.0 (12.1 to 28.7) | 15.4 (9.0 to 25.0) | 20.5 (14.9 to 27.5) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|
| Week 16 | 10.0 (2.8 to 30.1) | 28.6 (13.8 to 50.0) | 5.1 (1.4 to 16.9) |
| Week 36 | 15.0 (5.2 to 36.0) | 23.8 (10.6 to 45.1) | 15.4 (7.2 to 29.7) |
| Week 52 | 15.0 (5.2 to 36.0) | 19.0 (7.7 to 40.0) | 5.1 (1.4 to 16.9) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | RPR-Placebo | RPR-Bari 1-mg | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|---|
| Week 16 | 42.3 (29.9 to 55.8) | 62.2 (47.6 to 74.9) | 70.4 (57.2 to 80.9) | 64.3 (52.6 to 74.5) |
| Week 36 | 44.2 (31.6 to 57.7) | 46.7 (32.9 to 60.9) | 74.1 (61.1 to 83.9) | 51.4 (40.0 to 62.8) |
| Week 52 | 38.5 (26.5 to 52.0) | 51.1 (37.0 to 65.0) | 64.8 (51.5 to 76.2) | 51.4 (40.0 to 62.8) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | RPR-Placebo | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|
| Week 16 | 55.9 (39.5 to 71.1) | 67.9 (54.5 to 78.9) | 55.6 (43.3 to 67.2) |
| Week 36 | 47.1 (31.5 to 63.3) | 47.2 (34.4 to 60.3) | 44.4 (32.8 to 56.7) |
| Week 52 | 38.2 (23.9 to 55.0) | 52.8 (39.7 to 65.6) | 42.9 (31.4 to 55.1) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | NR: Bari 1 mg to 2 mg | NR: Bari 1 mg to 4 mg | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|---|---|
| Week 16 | 33.3 (24.3 to 43.8) | 43.2 (33.0 to 54.1) | 38.1 (28.4 to 48.8) | 38.5 (28.4 to 49.6) | 26.9 (20.6 to 34.4) |
| Week 36 | 32.2 (23.3 to 42.6) | 30.9 (21.9 to 41.6) | 31.0 (22.1 to 41.5) | 44.9 (34.3 to 55.9) | 30.8 (24.1 to 38.4) |
| Week 52 | 28.7 (20.3 to 39.0) | 35.8 (26.2 to 46.7) | 34.5 (25.2 to 45.2) | 34.6 (25.0 to 45.7) | 33.3 (26.4 to 41.1) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|
| Week 16 | 20.0 (8.1 to 41.6) | 57.1 (36.5 to 75.5) | 28.2 (16.5 to 43.8) |
| Week 36 | 25.0 (11.2 to 46.9) | 28.6 (13.8 to 50.0) | 23.1 (12.6 to 38.3) |
| Week 52 | 20.0 (8.1 to 41.6) | 28.6 (13.8 to 50.0) | 28.2 (16.5 to 43.8) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | RPR-Placebo | RPR-Bari 1-mg | RPR-Bari 2-mg | RPR-Bari 4-mg |
|---|---|---|---|---|
| RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 32.6 (20.5 to 47.5) | 25.8 (13.7 to 43.2) | 32.6 (20.5 to 47.5) | 41.0 (29.5 to 53.5) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | RPR Placebo | RPR Bari 2 mg | RPR Bari 4 mg |
|---|---|---|---|
| RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 37.5 (22.9 to 54.7) | 45.8 (32.6 to 59.7) | 46.4 (34.0 to 59.3) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | NR: Bari 1 mg to 2 mg | NR: Bari 1 mg to 4 mg | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|---|---|
| NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 20.0 (12.7 to 30.0) | 38.7 (27.6 to 51.2) | 24.3 (15.8 to 35.5) | 31.0 (21.4 to 42.5) | 22.5 (16.3 to 30.1) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | NR: Bari 2 mg to 2 mg | NR: Bari 2 mg to 4 mg | NR: Bari 4 mg to 4 mg |
|---|---|---|---|
| NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 31.6 (15.4 to 54.0) | 36.8 (19.1 to 59.0) | 31.4 (18.6 to 48.0) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 57.8 (50.5 to 64.8) | 67.0 (60.1 to 73.2) |
| Week 16 | 56.7 (49.4 to 63.7) | 62.9 (55.9 to 69.4) |
| Week 24 | 55.6 (48.3 to 62.6) | 57.2 (50.2 to 64.0) |
| Week 52 | 50.6 (43.3 to 57.8) | 46.9 (40.0 to 53.9) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 50.0 (34.1 to 65.9) | 46.4 (29.5 to 64.2) |
| Week 16 | 47.1 (31.5 to 63.3) | 46.4 (29.5 to 64.2) |
| Week 24 | 38.2 (23.9 to 55.0) | 39.3 (23.6 to 57.6) |
| Week 52 | 26.5 (14.6 to 43.1) | 25.0 (12.7 to 43.4) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 22.8 (17.3 to 29.4) | 25.8 (20.1 to 32.4) |
| Week 16 | 22.2 (16.8 to 28.8) | 29.9 (23.9 to 36.7) |
| Week 24 | 22.2 (16.8 to 28.8) | 27.8 (22.0 to 34.5) |
| Week 52 | 20.6 (15.3 to 27.0) | 23.7 (18.3 to 30.2) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 0 (0.0 to 10.2) | 14.3 (5.7 to 31.5) |
| Week 16 | 5.9 (1.6 to 19.1) | 25.0 (12.7 to 43.4) |
| Week 24 | 11.8 (4.7 to 26.6) | 17.9 (7.9 to 35.6) |
| Week 52 | 5.9 (1.6 to 19.1) | 10.7 (3.7 to 27.2) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 38.9 (32.1 to 46.2) | 46.9 (40.0 to 53.9) |
| Week 16 | 43.9 (36.8 to 51.2) | 53.6 (46.6 to 60.5) |
| Week 24 | 45.0 (37.9 to 52.3) | 45.4 (38.5 to 52.4) |
| Week 52 | 41.1 (34.2 to 48.4) | 38.7 (32.1 to 45.7) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| Week 4 | 23.5 (12.4 to 40.0) | 39.3 (23.6 to 57.6) |
| Week 16 | 38.2 (23.9 to 55.0) | 39.3 (23.6 to 57.6) |
| Week 24 | 32.4 (19.1 to 49.2) | 32.1 (17.9 to 50.7) |
| Week 52 | 26.5 (14.6 to 43.1) | 32.1 (17.9 to 50.7) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 33.9 (27.2 to 41.5) | 35.7 (28.9 to 43.1) |
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
| Percentage of participants | NR: Placebo to Bari 2 mg | NR: Placebo to Bari 4 mg |
|---|---|---|
| NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 20.6 (10.3 to 36.8) | 26.9 (13.7 to 46.1) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 86.9 (78.1 to 92.5) | 60.7 (50.0 to 70.5) | 50.0 (39.5 to 60.5) | 92.4 (85.1 to 96.3) | 70.3 (60.3 to 78.7) | 44.6 (34.8 to 54.7) |
| Week 104 | 85.7 (76.7 to 91.6) | 48.8 (38.4 to 59.3) | 41.7 (31.7 to 52.3) | 83.7 (74.8 to 89.9) | 58.2 (48.0 to 67.8) | 33.7 (24.9 to 43.8) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 51.2 (40.7 to 61.6) | 45.2 (35.0 to 55.9) | 29.8 (21.0 to 40.2) | 47.8 (37.9 to 57.9) | 41.8 (32.2 to 52.0) | 25.0 (17.3 to 34.7) |
| Week 104 | 47.6 (37.3 to 58.2) | 35.7 (26.3 to 46.4) | 33.3 (24.2 to 43.9) | 42.4 (32.8 to 52.6) | 38.5 (29.1 to 48.7) | 21.7 (14.5 to 31.2) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 79.8 (70.0 to 87.0) | 58.3 (47.7 to 68.3) | 45.2 (35.0 to 55.9) | 73.9 (64.1 to 81.8) | 69.2 (59.1 to 77.8) | 44.6 (34.8 to 54.7) |
| Week 104 | 73.8 (63.5 to 82.0) | 58.3 (47.7 to 68.3) | 41.7 (31.7 to 52.3) | 72.8 (63.0 to 80.9) | 58.2 (48.0 to 67.8) | 43.5 (33.8 to 53.7) |
Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated
| Days | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 117.0 (57.0 to 289.0) | 56.0 (29.0 to 170.0) | 29.5 (26.0 to 113.0) | 61.0 (29.0 to 269.0) | 169.0 (56.0 to 368.0) | 30.0 (28.0 to 87.0) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 97.7 (87.9 to 99.6) | 76.7 (62.3 to 86.8) | 72.1 (57.3 to 83.3) | 95.8 (86.0 to 98.8) | 89.6 (77.8 to 95.5) | 55.1 (41.3 to 68.1) |
| Week 104 | 90.7 (78.4 to 96.3) | 69.8 (54.9 to 81.4) | 62.8 (47.9 to 75.6) | 93.8 (83.2 to 97.9) | 77.1 (63.5 to 86.7) | 42.9 (30.0 to 56.7) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 74.4 (59.8 to 85.1) | 69.8 (54.9 to 81.4) | 55.8 (41.1 to 69.6) | 70.8 (56.8 to 81.8) | 66.7 (52.5 to 78.3) | 36.7 (24.7 to 50.7) |
| Week 104 | 62.8 (47.9 to 75.6) | 55.8 (41.1 to 69.6) | 58.1 (43.3 to 71.6) | 60.4 (46.3 to 73.0) | 60.4 (46.3 to 73.0) | 32.7 (21.2 to 46.6) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Week 68 | 93 (81.4 to 97.6) | 76.7 (62.3 to 86.8) | 72.1 (57.3 to 83.3) | 83.3 (70.4 to 91.3) | 89.6 (77.8 to 95.5) | 63.3 (49.3 to 75.3) |
| Week 104 | 76.7 (62.3 to 86.8) | 74.4 (59.8 to 85.1) | 67.4 (52.5 to 79.5) | 83.3 (70.4 to 91.3) | 79.2 (65.7 to 88.3) | 55.1 (41.3 to 68.1) |
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy) | 69.2 | 74.5 | 80.0 | 57.1 | 55.6 | 76.2 |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy) | 23.1 | 25.5 | 44.0 | 10.2 | 26.7 | 39.7 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
| Percentage of participants | 4 mg Bari to 4 mg Bari Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 2 mg Bari to 2 mg Bari Substudy | 2 mg Bari to 1 mg Bari SubstudY | 2 mg Bari to Placebo Substudy |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy) | 61.5 | 53.2 | 70.0 | 55.1 | 44.4 | 71.4 |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | Placebo to Placebo Non-substudy |
|---|---|---|---|---|
| Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | 41.3 (35.5 to 47.3) | 45.6 (38.7 to 52.6) | 71.9 (54.6 to 84.4) | 51.4 (40.0 to 62.8) |
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
| Percentage of participants | 4 mg Bari to 4 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | Placebo to Placebo Non-substudy |
|---|---|---|---|---|
| Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | 13.3 (9.7 to 17.9) | 13.5 (9.4 to 19.0) | 53.1 (36.4 to 69.1) | 40.0 (29.3 to 51.7) |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
| Percentage of participants | 4 mg Bari to 4 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | Placebo to Placebo Non-substudy |
|---|---|---|---|---|
| Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | 39.8 (34.1 to 45.8) | 40.9 (34.2 to 48.0) | 65.6 (48.3 to 79.6) | 54.3 (42.7 to 65.4) |
Collected over Baseline through Week 200. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/91 (0%) | 5/91 (5.5%) | 21/91 (23.1%) |
| Bari 1-mg | 0/45 (0%) | 1/45 (2.2%) | 14/45 (31.1%) |
| Bari 2-mg | 0/766 (0%) | 32/766 (4.2%) | 263/766 (34.3%) |
| Bari 4-mg | 1/743 (0.1%) | 40/743 (5.4%) | 268/743 (36.1%) |
| 2 mg Bari to Placebo Substudy | 1/92 (1.1%) | 2/92 (2.2%) | 15/92 (16.3%) |
| 2 mg Bari to 1 mg Bari Substudy | 0/91 (0%) | 1/91 (1.1%) | 27/91 (29.7%) |
| 2 mg Bari to 2 mg Bari Substudy | 0/92 (0%) | 3/92 (3.3%) | 38/92 (41.3%) |
| 4 mg Bari to Placebo Substudy | 0/84 (0%) | 3/84 (3.6%) | 16/84 (19%) |
| 4 mg Bari to 2 mg Bari Substudy | 0/84 (0%) | 1/84 (1.2%) | 21/84 (25%) |
| 4 mg Bari to 4 mg Bari Substudy | 0/84 (0%) | 11/84 (13.1%) | 42/84 (50%) |
| Placebo to Placebo Non-substudy | 0/70 (0%) | 1/70 (1.4%) | 14/70 (20%) |
| 1 mg Bari to 1 mg Bari Non-substudy | 0/32 (0%) | 3/32 (9.4%) | 14/32 (43.8%) |
| 2 mg Bari to 2 mg Bari Non-substudy | 0/249 (0%) | 16/249 (6.4%) | 96/249 (38.6%) |
| 4 mg Bari to 4 mg Bari Non-substudy | 1/264 (0.4%) | 25/264 (9.5%) | 110/264 (41.7%) |
| Event | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | 2 mg Bari to Placebo Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to 4 mg Bari Substudy | Placebo to Placebo Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 4 mg Bari to 4 mg Bari Non-substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Testis cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/47 | 0/29 | 0/448 | 0/504 | 0/48 | 0/61 | 0/49 | 0/48 | 0/54 | 0/53 | 0/36 | 1/20 | 0/159 | 0/190 |
| Autoimmune haemolytic anaemiaBlood and lymphatic system disorders | 0/91 | 0/45 | 0/766 | 0/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 0/70 | 1/32 | 0/249 | 0/264 |
| Otitis externaInfections and infestations | 0/91 | 0/45 | 0/766 | 1/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 0/70 | 1/32 | 0/249 | 0/264 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/91 | 0/45 | 0/766 | 0/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 2/84 | 0/70 | 0/32 | 0/249 | 0/264 |
| Uterine haemorrhageReproductive system and breast disorders | 1/44 | 0/16 | 0/318 | 0/239 | 0/44 | 0/30 | 0/43 | 0/36 | 0/30 | 0/31 | 0/34 | 0/12 | 0/90 | 0/74 |
| AppendicitisInfections and infestations | 0/91 | 1/45 | 0/766 | 0/743 | 0/92 | 0/91 | 1/92 | 0/84 | 0/84 | 0/84 | 0/70 | 0/32 | 0/249 | 0/264 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 1/91 | 0/45 | 10/766 | 9/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 0/70 | 0/32 | 2/249 | 5/264 |
| CellulitisInfections and infestations | 0/91 | 0/45 | 0/766 | 2/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 0/70 | 0/32 | 0/249 | 4/264 |
| Cardiovascular disorderCardiac disorders | 0/91 | 0/45 | 0/766 | 0/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 1/70 | 0/32 | 0/249 | 0/264 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/91 | 0/45 | 0/766 | 1/743 | 0/92 | 0/91 | 0/92 | 0/84 | 0/84 | 0/84 | 1/70 | 0/32 | 1/249 | 1/264 |
| Event | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | 2 mg Bari to Placebo Substudy | 2 mg Bari to 1 mg Bari Substudy | 2 mg Bari to 2 mg Bari Substudy | 4 mg Bari to Placebo Substudy | 4 mg Bari to 2 mg Bari Substudy | 4 mg Bari to 4 mg Bari Substudy | Placebo to Placebo Non-substudy | 1 mg Bari to 1 mg Bari Non-substudy | 2 mg Bari to 2 mg Bari Non-substudy | 4 mg Bari to 4 mg Bari Non-substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covid-19Infections and infestations | 0/91 | 0/45 | 0/766 | 0/743 | 2/92 | 9/91 | 14/92 | 7/84 | 4/84 | 14/84 | 3/70 | 7/32 | 33/249 | 29/264 |
| NasopharyngitisInfections and infestations | 10/91 | 9/45 | 106/766 | 122/743 | 5/92 | 3/91 | 10/92 | 6/84 | 8/84 | 11/84 | 1/70 | 1/32 | 27/249 | 26/264 |
| Herpes zosterInfections and infestations | 2/91 | 0/45 | 13/766 | 21/743 | 0/92 | 1/91 | 4/92 | 0/84 | 2/84 | 2/84 | 0/70 | 0/32 | 13/249 | 26/264 |
| Alanine aminotransferase increasedInvestigations | 0/91 | 0/45 | 13/766 | 10/743 | 0/92 | 0/91 | 1/92 | 0/84 | 0/84 | 2/84 | 1/70 | 3/32 | 4/249 | 6/264 |
| Urinary tract infectionInfections and infestations | 0/91 | 1/45 | 20/766 | 7/743 | 1/92 | 2/91 | 2/92 | 3/84 | 6/84 | 5/84 | 1/70 | 0/32 | 3/249 | 5/264 |
| Vulvovaginal candidiasisInfections and infestations | 0/44 | 0/16 | 4/318 | 0/239 | 0/44 | 2/30 | 1/43 | 0/36 | 0/30 | 1/31 | 0/34 | 0/12 | 0/90 | 0/74 |
| HeadacheNervous system disorders | 6/91 | 1/45 | 46/766 | 22/743 | 3/92 | 4/91 | 5/92 | 1/84 | 1/84 | 2/84 | 3/70 | 0/32 | 14/249 | 10/264 |
| PyrexiaGeneral disorders | 0/91 | 2/45 | 17/766 | 19/743 | 0/92 | 0/91 | 1/92 | 0/84 | 1/84 | 2/84 | 2/70 | 2/32 | 7/249 | 4/264 |
| Hepatic enzyme increasedInvestigations | 1/91 | 0/45 | 2/766 | 2/743 | 0/92 | 0/91 | 0/92 | 0/84 | 1/84 | 2/84 | 0/70 | 2/32 | 0/249 | 1/264 |
| Dermal cystSkin and subcutaneous tissue disorders | 0/91 | 0/45 | 0/766 | 4/743 | 0/92 | 0/91 | 1/92 | 0/84 | 0/84 | 2/84 | 0/70 | 2/32 | 3/249 | 0/264 |
Modified Intent-to-treat Population: All participants who received at least one dose of investigational product (IP) in JAHN.
| Age, Continuous(years) | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| Mean | 35.2 ± 14.06 | 33.5 ± 8.49 | 34.2 ± 12.69 | 35.6 ± 12.85 | 34.9 ± 12.98 | 34.9 ± 12.83 |
| Sex: Female, Male(Participants) | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| Female | 44 | 16 | 206 | 239 | 112 | 617 |
| Male | 47 | 29 | 313 | 504 | 135 | 1028 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 15 | 10 | 70 | 87 | 72 | 254 |
| Not Hispanic or Latino | 57 | 32 | 332 | 467 | 165 | 1053 |
| Unknown or Not Reported | 19 | 3 | 117 | 189 | 10 | 338 |
| Race (NIH/OMB)(Participants) | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 6 | 4 | 10 | 6 | 16 | 42 |
| Asian | 32 | 7 | 174 | 282 | 13 | 508 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 0 | 0 | 1 | 1 | 1 | 3 |
| White | 48 | 32 | 315 | 429 | 211 | 1035 |
| More than one race | 5 | 2 | 18 | 23 | 6 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 0 | 2 |
| Region of Enrollment(Participants) | Placebo | Bari 1-mg | Bari 2-mg | Bari 4-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| Argentina | 6 | 2 | 36 | 46 | 24 | 114 |
| Hungary | 7 | 2 | 15 | 21 | 27 | 72 |
| Czechia | 3 | 3 | 22 | 46 | 28 | 102 |
| Japan | 11 | 3 | 89 | 141 | 0 | 244 |
| Switzerland | 0 | 1 | 5 | 9 | 3 | 18 |
| India | 5 | 0 | 7 | 19 | 0 | 31 |
| Spain | 2 | 1 | 27 | 26 | 24 | 80 |
| Russia | 0 | 1 | 9 | 13 | 28 | 51 |
| Austria | 2 | 0 | 12 | 23 | 12 | 49 |
| South Korea | 9 | 1 | 39 | 58 | 0 | 107 |
| Taiwan | 8 | 2 | 30 | 50 | 0 | 90 |
| Denmark | 0 | 0 | 0 | 0 | 7 | 7 |
| Poland | 10 | 7 | 45 | 70 | 0 | 132 |
| Italy | 7 | 4 | 16 | 26 | 15 | 68 |
| Mexico | 9 | 5 | 29 | 21 | 43 | 107 |
| Israel | 1 | 0 | 16 | 13 | 4 | 34 |
| France | 0 | 0 | 15 | 19 | 0 | 34 |
| Australia | 4 | 1 | 30 | 42 | 32 | 109 |
| Germany | 7 | 12 | 77 | 100 | 0 | 196 |
Showing the first 100 of 185 sites across 19 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Ran from Mar 2018 to primary completion in Sep 2020, 29 months.
Results were first posted in Jul 2022, 1 year 9 months after primary completion.
Of 150 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 29 months is above that.
Counting every sponsor, half of 157 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 Aug 2024. 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 trackQuestions 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: Baricitinib