Status:
COMPLETED
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Dermatitis, Atopic
Dermatitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04760314
Start Date
March 10 2021
End Date
February 1 2023
Last Update
August 23 2023
Active Locations (37)
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1
Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, Japan, 272-0143
2
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, Japan, 272-0033
3
Charme Clinique
Matsudo, Chiba, Japan, 270-2223
4
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, Japan, 818-0083