A Phase 3 interventional study of Baricitinib and Placebo in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 93 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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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 is the 2nd largest by enrollment, is one of 2 that started in 2017, 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. 2 started in 2017.
This study's enrollment of 660 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.
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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 is the 3rd largest by enrollment, is one of 2 that started in 2017, 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:
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The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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.
4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
Placebo administered orally once daily.
Drug: Placebo
4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Drug: Baricitinib · Drug: Placebo
Placebo administered orally once daily.
Drug: Placebo
Administered orally.
Also known as: LY3009104
Administered orally.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)
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.
Time frame: 16 Weeks
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)
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.
Time frame: 16 Weeks
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
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 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: 16 Weeks
Percentage of Participants Achieving EASI90
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 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
Time frame: 16 Weeks
Percent Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect
Time frame: Baseline, 16 Weeks
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Time frame: 16 Weeks
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
The Itch Numeric Rating Scale (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.
Time frame: 16 Weeks
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Percentage of Participants Achieving EASI50
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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
Time frame: 16 Weeks
Percentage of Participants Achieving IGA of 0
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.
Time frame: 16 Weeks
Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Percentage of Participants Achieving SCORAD90
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
Time frame: 16 Weeks
Change From Baseline in Body Surface Area (BSA) Affected
Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSAhead and neck + 0.3\*BSAtrunk + 0.2\* BSAupper limbs + 0.4\*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Percentage of participants developing skin infections requiring antibiotic treatment.
Time frame: 16 Weeks
Percent Change From Baseline in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline in the Dermatology Life Quality Index (DLQI)
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Time frame: Baseline, 16 Weeks
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
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.
Time frame: 4 Weeks
Participants who completed double blind treatment phase had option to enter extension study I4V-MC-JAHN (NCT03334435).
| Milestone | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment (MEE) | 1 mg Baricitinib MEE | 2 mg Baricitinib MEE | 4 mg Baricitinib MEE |
|---|---|---|---|---|---|---|---|---|
| Started | 249 | 127 | 123 | 125 | 15 | 5 | 8 | 8 |
| Received at least one dose of study drug | 249 | 127 | 123 | 125 | 15 | 5 | 8 | 8 |
| Completed | 226 | 116 | 113 | 120 | 12 | 4 | 5 | 7 |
| Not completed | 23 | 11 | 10 | 5 | 3 | 1 | 3 | 1 |
| Withdrew: Adverse event | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 10 | 4 | 1 | 3 | 1 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 10 | 5 | 7 | 2 | 2 | 1 | 2 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligible | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Started new job | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 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.
| percentage of participants | Placebo | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib) | 4.8 | 11.4 | 16.8 |
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.
| percentage of participants | Placebo | 1 mg Baricitinib |
|---|---|---|
| Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib) | 4.8 | 11.8 |
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 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) | 8.8 | 17.3 | 18.7 | 24.8 |
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 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI90 | 4.8 | 8.7 | 10.6 | 16.0 |
The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect
| percent change | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percent Change From Baseline in EASI Score | -34.82 ± 3.64 | -48.22 ± 4.52 | -51.89 ± 4.29 | -59.36 ± 3.84 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) | 1.2 | 5.5 | 7.3 | 10.4 |
The Itch Numeric Rating Scale (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.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 7.2 | 10.5 | 12.0 | 21.5 |
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) | -0.84 ± 0.15 | -1.21 ± 0.18 | -1.04 ± 0.17 | -1.42 ± 0.16 |
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in the Skin Pain Numeric Rating Scale (NRS) | -0.84 ± 0.24 | -1.92 ± 0.30 | -1.58 ± 0.29 | -1.93 ± 0.26 |
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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI50 | 15.3 | 26.0 | 30.1 | 41.6 |
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.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving IGA of 0 | 0.8 | 1.6 | 2.4 | 1.6 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in SCORAD | -13.51 ± 2.00 | -18.85 ± 2.48 | -21.47 ± 2.36 | -28.30 ± 2.10 |
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving SCORAD90 | 0.8 | 0.8 | 2.4 | 2.4 |
Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSAhead and neck + 0.3\*BSAtrunk + 0.2\* BSAupper limbs + 0.4\*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in Body Surface Area (BSA) Affected | -14.80 ± 1.82 | -20.79 ± 2.26 | -20.14 ± 2.16 | -25.96 ± 1.93 |
Percentage of participants developing skin infections requiring antibiotic treatment.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | 4.4 | 0.8 | 4.9 | 3.2 |
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| Percent Change | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percent Change From Baseline in Itch NRS | -12.04 ± 4.65 | -31.30 ± 5.70 | -29.43 ± 5.45 | -36.55 ± 4.88 |
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) | -2.68 ± 0.76 | -5.32 ± 0.93 | -6.26 ± 0.91 | -7.84 ± 0.80 |
The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score | -0.31 ± 0.09 | -0.58 ± 0.12 | -0.58 ± 0.11 | -0.77 ± 0.10 |
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Anxiety | -0.90 ± 0.28 | -1.35 ± 0.34 | -1.83 ± 0.33 | -2.05 ± 0.30 |
| Depression | -0.37 ± 0.27 | -1.04 ± 0.34 | -1.40 ± 0.32 | -1.50 ± 0.29 |
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline in the Dermatology Life Quality Index (DLQI) | -2.46 ± 0.57 | -4.64 ± 0.70 | -4.30 ± 0.68 | -6.76 ± 0.60 |
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Absenteeism | -0.49 ± 1.68 | -4.54 ± 2.15 | -0.84 ± 2.23 | -3.89 ± 1.88 |
| Presenteeism | -2.89 ± 2.60 | -9.75 ± 3.37 | -11.53 ± 3.44 | -15.17 ± 2.95 |
| Work Productivity Loss | -2.57 ± 2.89 | -11.23 ± 3.75 | -9.06 ± 3.83 | -13.85 ± 3.29 |
| Activity Impairment | -5.67 ± 2.16 | -12.98 ± 2.63 | -10.80 ± 2.57 | -22.20 ± 2.30 |
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| units on a scale | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Health State Index Score (US Algorithm) | 0.01 ± 0.01 | 0.05 ± 0.02 | 0.05 ± 0.02 | 0.09 ± 0.01 |
| Health State Index Score (UK Algorithm) | 0.01 ± 0.02 | 0.07 ± 0.02 | 0.07 ± 0.02 | 0.13 ± 0.02 |
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
| millimeters | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) | 2.00 ± 2.04 | 4.97 ± 2.53 | 3.35 ± 2.41 | 9.05 ± 2.17 |
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.
| percentage of participants | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib |
|---|---|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement | 2.4 | 3.1 | 8.9 | 10.4 |
Collected over Baseline Up to 20 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/249 (0%) | 6/249 (2.4%) | 55/249 (22.1%) |
| 1 mg Baricitinib | 0/127 (0%) | 1/127 (0.8%) | 37/127 (29.1%) |
| 2 mg Baricitinib | 0/123 (0%) | 0/123 (0%) | 34/123 (27.6%) |
| 4 mg Baricitinib | 0/125 (0%) | 2/125 (1.6%) | 29/125 (23.2%) |
| Placebo Maximum Extended Enrollment | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| 1 mg Baricitinib Maximum Extended Enrollment | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| 2 mg Baricitinib Maximum Extended Enrollment | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| 4 mg Baricitinib Maximum Extended Enrollment | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Event | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment | 1 mg Baricitinib Maximum Extended Enrollment | 2 mg Baricitinib Maximum Extended Enrollment | 4 mg Baricitinib Maximum Extended Enrollment |
|---|---|---|---|---|---|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 2/249 | 1/127 | 0/123 | 1/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Alcohol poisoningInjury, poisoning and procedural complications | 0/249 | 0/127 | 0/123 | 1/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Clavicle fractureInjury, poisoning and procedural complications | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Rib fractureInjury, poisoning and procedural complications | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Suicide attemptPsychiatric disorders | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Event | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment | 1 mg Baricitinib Maximum Extended Enrollment | 2 mg Baricitinib Maximum Extended Enrollment | 4 mg Baricitinib Maximum Extended Enrollment |
|---|---|---|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 0/249 | 1/127 | 3/123 | 1/125 | 0/15 | 1/5 | 1/8 | 1/8 |
| NasopharyngitisInfections and infestations | 26/249 | 22/127 | 12/123 | 12/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| Vulvovaginal candidiasisInfections and infestations | 1/101 | 0/49 | 0/41 | 0/42 | 1/6 | 0/2 | — | 0/2 |
| Abdominal painGastrointestinal disorders | 1/249 | 2/127 | 3/123 | 0/125 | 0/15 | 0/5 | 0/8 | 1/8 |
| NauseaGastrointestinal disorders | 2/249 | 1/127 | 1/123 | 1/125 | 0/15 | 0/5 | 0/8 | 1/8 |
| Oedema peripheralGeneral disorders | 1/249 | 0/127 | 0/123 | 0/125 | 0/15 | 0/5 | 0/8 | 1/8 |
| Skin infectionInfections and infestations | 1/249 | 0/127 | 1/123 | 0/125 | 0/15 | 0/5 | 0/8 | 1/8 |
| Urinary tract infectionInfections and infestations | 4/249 | 1/127 | 2/123 | 4/125 | 0/15 | 0/5 | 1/8 | 1/8 |
| HeadacheNervous system disorders | 16/249 | 7/127 | 14/123 | 10/125 | 0/15 | 0/5 | 0/8 | 0/8 |
| DiarrhoeaGastrointestinal disorders | 7/249 | 9/127 | 0/123 | 4/125 | 1/15 | 0/5 | 0/8 | 0/8 |
All randomized participants. Results for maximum extended enrollment (MEE) participants will be reported within 1-year after the study completion.
| Age, Categorical(Participants) | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment (MEE) | 1 mg Baricitinib MEE | 2 mg Baricitinib MEE | 4 mg Baricitinib MEE | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Between 18 and 65 years | 242 | 127 | 118 | 121 | 15 | 5 | 6 | 8 | 642 |
| >=65 years | 7 | 0 | 5 | 4 | 0 | 0 | 1 | 0 | 17 |
| Sex: Female, Male(Participants) | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment (MEE) | 1 mg Baricitinib MEE | 2 mg Baricitinib MEE | 4 mg Baricitinib MEE | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 101 | 49 | 41 | 42 | 6 | 2 | 0 | 2 | 243 |
| Male | 148 | 78 | 82 | 83 | 9 | 3 | 8 | 6 | 417 |
| Race (NIH/OMB)(Participants) | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment (MEE) | 1 mg Baricitinib MEE | 2 mg Baricitinib MEE | 4 mg Baricitinib MEE | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 14 | 7 | 7 | 2 | 0 | 0 | 0 | 0 | 30 |
| Asian | 73 | 40 | 35 | 41 | 15 | 5 | 8 | 8 | 225 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| White | 147 | 74 | 75 | 70 | 0 | 0 | 0 | 0 | 366 |
| More than one race | 13 | 6 | 5 | 10 | 0 | 0 | 0 | 0 | 34 |
| Unknown or Not Reported | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 |
| Region of Enrollment(Participants) | Placebo | 1 mg Baricitinib | 2 mg Baricitinib | 4 mg Baricitinib | Placebo Maximum Extended Enrollment (MEE) | 1 mg Baricitinib MEE | 2 mg Baricitinib MEE | 4 mg Baricitinib MEE | Total |
|---|---|---|---|---|---|---|---|---|---|
| Czechia | 36 | 11 | 11 | 18 | 0 | 0 | 0 | 0 | 76 |
| Japan | 45 | 23 | 21 | 22 | 0 | 0 | 0 | 0 | 111 |
| Taiwan | 25 | 13 | 13 | 12 | 0 | 0 | 0 | 0 | 63 |
| Italy | 17 | 8 | 6 | 13 | 0 | 0 | 0 | 0 | 44 |
| Mexico | 32 | 15 | 17 | 9 | 0 | 0 | 0 | 0 | 73 |
| France | 15 | 4 | 13 | 7 | 0 | 0 | 0 | 0 | 39 |
| Germany | 67 | 44 | 37 | 30 | 0 | 0 | 0 | 0 | 178 |
| India | 1 | 2 | 1 | 6 | 15 | 5 | 8 | 8 | 46 |
| Russia | 11 | 7 | 4 | 8 | 0 | 0 | 0 | 0 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2017 to primary completion in Dec 2018, 12 months.
Results were first posted in Jan 2020, 1 year 1 month 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 12 months is below 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 Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Baricitinib