Phase 3
Completed N=440
A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03435081 ↗Enrolled (actual)
440
Serious AEs
1.2%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) — 8.2; 29.5 percentage of participants — p=<0.001
◆ Published Evidence
Established
56citations · ~14 / year
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.
Summary
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.
Linked Publications (5)
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The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis.
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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.
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Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16.
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Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials.
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Onset of Symptom Relief Reported in Daily Diaries of Patients With Atopic Dermatitis Treated With Baricitinib in a United States Clinical Trial (BREEZE-AD5).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) |
8.2; 29.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement |
2.7; 5.4; 8.2 | 0.258 |
| SECONDARY Percentage of Participants Achieving EASI75 (1 mg Baricitinib) |
8.2; 12.9 | 0.167 |
| SECONDARY Percentage of Participants Achieving EASI90 |
3.4; 7.5; 20.5 | 0.131 |
| SECONDARY Percent Change From Baseline in EASI Score |
-34.07; -46.66; -54.37 | 0.077 |
| SECONDARY Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) |
2.7; 3.4; 14.4 | 0.733 |
| SECONDARY Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS) |
5.7; 15.9; 25.2 | 0.012 sig |
| SECONDARY Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) |
-0.40; -0.62; -0.99 | 0.433 |
| SECONDARY Change From Baseline in Skin Pain NRS |
-1.03; -2.16; -2.40 | 0.012 sig |
| SECONDARY Percentage of of Participants Achieving EASI50 |
12.9; 19.7; 34.9 | 0.105 |
| SECONDARY Percentage of Participants Achieving IGA of 0 |
0.7; 3.4; 2.7 | 0.144 |
| SECONDARY Change From Baseline in SCORAD |
-14.37; -18.31; -26.18 | 0.316 |
| SECONDARY Percentage of Participants Achieving SCORAD90 |
1.4; 2.0; 3.4 | 0.683 |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Affected |
-9.67; -15.69; -17.39 | 0.046 sig |
| SECONDARY Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment |
5.5; 4.1; 4.1 | 0.598 |
| SECONDARY Percent Change From Baseline in Itch NRS |
-18.01; -30.28; -39.87 | 0.063 |
| SECONDARY Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) |
-2.67; -4.57; -7.44 | 0.217 |
| SECONDARY Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score |
-0.46; -0.71; -0.88 | 0.155 |
| SECONDARY Change From Baseline on the Hospital Anxiety Depression Scale (HADS) |
-2.03; -1.50; -2.55; -1.31; -0.87; -1.73 | 0.345 |
| SECONDARY Change From Baseline on the Dermatology Life Quality Index (DLQI) |
-3.97; -5.47; -7.46 | 0.224 |
| SECONDARY Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire |
3.41; 0.05; 2.34; -3.44; -15.18; -19.33 | 0.575 |
| 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 |
0.04; 0.06; 0.10; 0.07; 0.09; 0.14 | 0.482 |
| SECONDARY Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) |
4.67; 3.34; 8.14 | 0.609 |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement |
2.7; 5.4; 8.2 | 0.258 |
Eligibility Criteria
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:
- EASI score ≥16
- IGA score of ≥3
- ≥10% of BSA involvement
- 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:
- monoclonal antibody for less than 5 half-lives before randomization
- received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks before randomization
- received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- have had an intra-articular corticosteroid injection within 6 weeks of planned randomization
- probenecid at the time of randomization that cannot be discontinued for the duration of the study
- 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.
Data sourced from ClinicalTrials.gov (NCT03435081) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.