Phase 3
N=286
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis, Atopic · Dermatitis · Eczema · Skin Diseases · Skin Diseases, Genetic
Bottom Line
View on ClinicalTrials.gov: NCT04760314 ↗Enrolled (actual)
286
Serious AEs
1.7%
Results posted
Aug 2023
Primary outcome: Primary: Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 — 6.1; 29.1; 33.4 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lebrikizumab (Drug); Placebo (Drug); Topical Corticosteroid (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 |
6.1; 29.1; 33.4 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16 |
13.4; 47.2; 51.2 | <0.001 sig |
| SECONDARY Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16 |
-25.25; -59.74; -64.23 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 at Week 16 |
9.8; 28.4; 34.3 | 0.003 sig |
| SECONDARY Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1 |
0; 0; 1.3 | 0.404 |
| SECONDARY Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2 |
0; 1.7; 3.8 | 0.294 |
| SECONDARY Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4 |
0; 8.5; 16.3 | 0.013 sig |
| SECONDARY Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16 |
3.3; 23.8; 32.7 | 0.001 sig |
Summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.
Eligibility Criteria
Inclusion Criteria
- Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the screening.
- Have moderate-to-severe AD, including all of the following:
- EASI score ≥16 at the baseline
- IGA score ≥3 (scale of 0 to 4) at the baseline
- AD involvement on ≥10% of Body Surface Area (BSA) at the baseline
- Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:
- Inability to achieve good disease control, defined as mild disease or better (for example, IGA ≤2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.
- Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.
- Body weight ≥40 kilogram (kg)
Exclusion Criteria
- Have a history of anaphylaxis
- Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline.
- Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.
- Evidence of acute or chronic hepatitis or known liver cirrhosis.
- Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.
- Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.
- Have presence of significant uncontrolled neuropsychiatric disorder.
- Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.
Data sourced from ClinicalTrials.gov (NCT04760314). 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.