A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Overview
- Phase
- Phase 3
- Intervention
- Baricitinib
- Conditions
- Atopic Dermatitis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 660
- Locations
- 92
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
- •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 prior to randomization.
- •Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- •Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- •Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- •Have high blood pressure characterized by a repeated systolic blood pressure \>160 millimeters of mercury (mm Hg) or diastolic blood pressure \>100 mm Hg.
Arms & Interventions
2 mg Baricitinib
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Intervention: Baricitinib
4 milligram (mg) Baricitinib
4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
Intervention: Baricitinib
4 milligram (mg) Baricitinib
4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match.
Intervention: Placebo
2 mg Baricitinib
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Intervention: Placebo
1 mg Baricitinib
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Intervention: Baricitinib
1 mg Baricitinib
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Intervention: Placebo
Placebo
Placebo administered orally once daily.
Intervention: Placebo
4 mg Baricitinib Maximum Extended Enrollment Cohort
4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
Intervention: Baricitinib
4 mg Baricitinib Maximum Extended Enrollment Cohort
4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match.
Intervention: Placebo
2 mg Baricitinib Maximum Extended Enrollment Cohort
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Intervention: Baricitinib
2 mg Baricitinib Maximum Extended Enrollment Cohort
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match.
Intervention: Placebo
1 mg Baricitinib Maximum Extended Enrollment Cohort
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Intervention: Baricitinib
1 mg Baricitinib Maximum Extended Enrollment Cohort
1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match.
Intervention: Placebo
Placebo Maximum Extended Enrollment Cohort
Placebo administered orally once daily.
Intervention: Placebo
Outcomes
Primary Outcomes
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)
Time Frame: 16 Weeks
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.
Secondary Outcomes
- Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)(16 Weeks)
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)(16 Weeks)
- Percentage of Participants Achieving EASI90(16 Weeks)
- Percent Change From Baseline in EASI Score(Baseline, 16 Weeks)
- Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)(16 Weeks)
- Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)(16 Weeks)
- Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)(Baseline, 16 Weeks)
- Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)(Baseline, 16 Weeks)
- Percentage of Participants Achieving EASI50(16 Weeks)
- Percentage of Participants Achieving IGA of 0(16 Weeks)
- Change From Baseline in SCORAD(Baseline, 16 Weeks)
- Percentage of Participants Achieving SCORAD90(16 Weeks)
- Change From Baseline in Body Surface Area (BSA) Affected(Baseline, 16 Weeks)
- Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment(16 Weeks)
- Percent Change From Baseline in Itch NRS(Baseline, 16 Weeks)
- Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)(Baseline, 16 Weeks)
- Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score(Baseline, 16 Weeks)
- Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)(Baseline, 16 Weeks)
- Change From Baseline in the Dermatology Life Quality Index (DLQI)(Baseline, 16 Weeks)
- Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire(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(Baseline, 16 Weeks)
- Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)(Baseline, 16 Weeks)
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement(4 Weeks)