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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAIW | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 milligram (mg) Baricitinib | Experimental | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
| 1 mg Baricitinib | Experimental | 1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
| Placebo | Placebo Comparator | Placebo administered orally every day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.
Have moderate to severe AD, including all of the following:
Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Agree to use emollients daily.
Exclusion Criteria:
Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of venous thromboembolic event (VTE), or are considered at high risk for VTE.
Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Johnson Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36749121 | Derived | Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6. | |
| 35442530 |
| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis (Eczema) (BREEZE-AD5) | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants who did not meet IGA 0 or 1 at Week 16 and completed at least 16 Weeks in JAIW were discontinued and if eligible had the option to roll over into the Open-Label Extension study JAIX (NCT03559720).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered orally every day. |
| FG001 | 1 Milligram (mg) Baricitinib | 1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 0 to Week 16 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2019 | Aug 7, 2020 |
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| Placebo | Drug | Administered orally |
|
| Week 16 |
| Percentage of Participants Achieving EASI75 (1 mg Baricitinib) | 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. | Week 16 |
| 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. | Week 16 |
| Percent Change From Baseline in EASI Score | 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). Least Squares (LS) Means were calculated using a MMRM model with treatment, 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. | Baseline, Week 16 |
| 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 a visual analogue scales (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. | Week 16 |
| Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS) | The Itch NRS is a patient-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 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. | 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. | Baseline, Week 16 |
| Change From Baseline in Skin Pain 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, 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. | Baseline, Week 16 |
| Percentage of 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. | Week 16 |
| 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. | Week 16 |
| 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, baseline disease severity (IGA), visit and treatment-by-visit interaction as fixed categorial effects and baseline and baseline-by-visit interaction as fixed continuous effects. | Baseline, Week 16 |
| 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. | Week 16 |
| 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 a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | Baseline, Week 16 |
| Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | Percentage of participants developing skin infections requiring antibiotic treatment. | Week 16 |
| 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, baseline disease severity (IGA),and treatment-by-visit-interaction as fixed categorical effects and baseline, and baseline-by-visit-interaction as fixed continuous effects. | Baseline, Week 16 |
| 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, 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. | Baseline, Week 16 |
| Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score | The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, 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. | Baseline, Week 16 |
| Change From Baseline on the Hospital Anxiety 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, 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. | Baseline, Week 16 |
| Change From Baseline on 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 little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), 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, baseline disease severity (IGA),visit, and treatment-by-visit-interaction as fixed categorical and baseline, and baseline-by-visit-interaction as fixed continuous effects. | Baseline, Week 16 |
| 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 Mean were calculated using a MMRM model with treatment, 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. | Baseline, Week 16 |
| Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm | The 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 UK algorithm, with scores ranging from -0.594 to 1, and the US algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | Baseline, Week 16 |
| 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 ranges 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 a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | Baseline, Week 16 |
| 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. | Week 4 |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Wallace Medical Group, Inc. | Beverly Hills | California | 90211 | United States |
| California Dermatology and Clinical Research Institute | Encinitas | California | 92024 | United States |
| Tien Q. Nguyen, MD inc. DBA First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Keck School of Medicine University of Southern California | Los Angeles | California | 90033 | United States |
| University of California Davis-Dermatology | Sacramento | California | 95816 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| University Clinical Trials, Inc. | San Diego | California | 92123 | United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Care Access Research-Walnut Creek | Walnut Creek | California | 94598 | United States |
| Clinical Research Center of CT/NY | Danbury | Connecticut | 06810 | United States |
| Univ of Connecticut | Farmington | Connecticut | 06032 | United States |
| GWU/Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Solutions Through Advanced Research, Inc. | Jacksonville | Florida | 32256 | United States |
| Olympian Clinical Research | Largo | Florida | 33770 | United States |
| Miami Dermatology & Laser Research | Miami | Florida | 33173 | United States |
| Riverchase Dermatology and Cosmetic Surgery | Pembroke Pines | Florida | 33028 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Dermatologic Surgery Specialists, PC | Macon | Georgia | 31217 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Treasure Valley Dermatology | Boise | Idaho | 83713 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University Dermatology | Darien | Illinois | 60561 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Dawes Fretzin Clinical Research | Indianapolis | Indiana | 46250 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| The South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Dermatology Specialist | Louisville | Kentucky | 40241 | United States |
| Dermatology and Skin Cancer Specialists | Rockville | Maryland | 20850 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Central Dermatology PC | St Louis | Missouri | 63117 | United States |
| Skin Specialists, P.C | Omaha | Nebraska | 68144 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10003 | United States |
| DermResearchCenter of New York, Inc | Stony Brook | New York | 11790 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Wright State Univ School of Medicine | Fairborn | Ohio | 45324 | United States |
| Dermatologists of Southwest Ohio, Inc. | Mason | Ohio | 45040 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| Dermatology and Skin Surgery Center | Exton | Pennsylvania | 19341 | United States |
| Clinical Partners LLC | Johnston | Rhode Island | 02919 | United States |
| Dermatology & Laser Center of Charleston | Charleston | South Carolina | 29407 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Bellaire Dermatology | Bellaire | Texas | 77401 | United States |
| Modern Research Associates PLLC | Dallas | Texas | 75231 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Acclaim Dermatology, PLLC | Sugar Land | Texas | 77497 | United States |
| University of Utah MidValley Dematology | Murray | Utah | 84107 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23502 | United States |
| Multicare Health System | Tacoma | Washington | 98405 | United States |
| Kirk Barber Research | Calgary | Alberta | T2G 1B1 | Canada |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Dr. Chih-ho Hong Medical Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Simcoderm Medical & Surgical Dermatology Centre | Barrie | Ontario | L4M 7G1 | Canada |
| Kingsway Clinical Research | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Medicor Research Inc | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P1X2 | Canada |
| Allergy Research Canada Inc. | Niagara Falls | Ontario | L2H 1H5 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| K. Papp Clinical Research Inc | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2K4L5 | Canada |
| Centre de Recherche Dermatologique de Quebec Metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| York Dermatology Center | Richmond Hill | L4C 9M7 | Canada |
| Office of Dr. Samuel Sanchez PSC | Caguas | PR | 00727 | Puerto Rico |
| Office of Dr. Alma M. Cruz | Carolina | PR | 00985 | Puerto Rico |
| Ponce School of Medicine CAIMED Center | Ponce | PR | 00716 | Puerto Rico |
| GCM Medical Group PSC | San Juan | PR | 00917 | Puerto Rico |
| Simpson EL, Bissonnette R, Paller AS, King B, Silverberg JI, Reich K, Thyssen JP, Doll H, Sun L, DeLozier AM, Nunes FP, Eichenfield LF. The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): a clinical outcome measure for the severity of atopic dermatitis. Br J Dermatol. 2022 Oct;187(4):531-538. doi: 10.1111/bjd.21615. Epub 2022 Aug 21. |
| 35086348 | Derived | Rosmarin D, Casillas M, Chen S, Dawson Z, Pierce E, Zhang H, Bukhalo M, Smith S. Onset of Symptom Relief Reported in Daily Diaries of Patients With Atopic Dermatitis Treated With Baricitinib in a United States Clinical Trial (BREEZE-AD5). J Cutan Med Surg. 2022 May-Jun;26(3):262-266. doi: 10.1177/12034754211073661. Epub 2022 Jan 28. |
| 34846636 | Derived | Silverberg JI, Boguniewicz M, Waibel J, Weisman J, Strowd L, Sun L, Ding Y, Feely M, Nunes FP, Simpson EL. Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16. Dermatol Ther (Heidelb). 2022 Jan;12(1):137-148. doi: 10.1007/s13555-021-00640-7. Epub 2021 Nov 30. |
| 34688290 | Derived | Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8. |
| 33826132 | Derived | King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7. |
| FG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
| Received at Least One Dose of Study Drug |
|
| Completed Week 16 and Entered JAIX Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Week 16 to Week 104 |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered orally every day. |
| BG001 | 1 mg Baricitinib | 1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
| BG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) | 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. | All participants randomized to placebo or 2 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving EASI75 (1 mg Baricitinib) | 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. | All participants randomized to placebo or 1 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | Percent Change From Baseline in EASI Score | 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). Least Squares (LS) Means were calculated using a MMRM model with treatment, 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. | All randomized participants with Week 16 EASI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 16 |
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| Secondary | 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 a visual analogue scales (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. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS) | The Itch NRS is a patient-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 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. | All randomized participants with a Baseline Itch NRS score >=4. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 Weeks |
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| Secondary | 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. | All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in Skin Pain 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, 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. | All randomized participants with Week 16 Skin Pain NRS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Percentage of 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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, baseline disease severity (IGA), visit and treatment-by-visit interaction as fixed categorial effects and baseline and baseline-by-visit interaction as fixed continuous effects. | All randomized participants with Week 16 SCORAD data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | 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 a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | All randomized participants with Week 16 BSA data. | Posted | Least Squares Mean | Standard Error | percentage of BSA | Baseline, Week 16 |
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| Secondary | Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | Percentage of participants developing skin infections requiring antibiotic treatment. | All randomized participants who received at least 1 dose of study drug and who did not discontinue from study for reason lost to follow-up at the first post-baseline visit. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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, baseline disease severity (IGA),and treatment-by-visit-interaction as fixed categorical effects and baseline, and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 Itch NRS data. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 16 |
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| Secondary | 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, 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. | All randomized participants with Week 16 POEM data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score | The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, 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. | All randomized participants with Week 16 PGI-S-AD data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline on the Hospital Anxiety 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, 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. | All randomized participants with Week 16 HADS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline on 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 little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), 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, baseline disease severity (IGA),visit, and treatment-by-visit-interaction as fixed categorical and baseline, and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 DLQI data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | 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 Mean were calculated using a MMRM model with treatment, 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. | All randomized participants with baseline and at least 1 post-baseline WPAI measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States (US) and United Kingdom (UK) Algorithm | The 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 UK algorithm, with scores ranging from -0.594 to 1, and the US algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | All randomized participants with Week 16 EQ-5D-5L Index Score US and UK Algorithm | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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| Secondary | 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 ranges 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 a MMRM model with treatment, baseline disease activity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects. | All randomized participants with Week 16 EQ-5D-5L VAS data. | Posted | Least Squares Mean | Standard Error | millimeters | Baseline, Week 16 |
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| Secondary | 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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Baseline up to Week 104
All randomized participants who receive at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit.
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Period 1 WK 0 to 16) | Placebo administered orally every day (Period 1 WK 0 to 16) | 0 | 146 | 3 | 146 | 34 | 146 |
| EG001 | 1 Milligram (mg) Baricitinib (Period 1 WK 0 to 16) | 1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16) | 0 | 147 | 1 | 147 | 24 | 147 |
| EG002 | 2 mg Baricitinib (Period 1 WK 0 to 16) | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 1 WK 0 to 16) | 0 | 145 | 2 | 145 | 36 | 145 |
| EG003 | Placebo (Period 2 WK 16 to 104) | Placebo administered orally every day (Period 2 WK 16 to 104) | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | 1 mg Baricitinib (Period 2 WK 16 to 104) | 1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104) | 0 | 19 | 0 | 19 | 10 | 19 |
| EG005 | 2 mg Baricitinib (Period 2 WK 16 to 104) | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. (Period 2 WK 16 to 104) | 0 | 35 | 0 | 35 | 11 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2021 | Jun 28, 2022 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Non--Compliance |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| Participants |
|
|
|
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| 2 mg Baricitinib |
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
|
|
|
| OG002 |
| 2 mg Baricitinib |
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| 2 mg Baricitinib |
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| 2 mg Baricitinib |
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|