Status:
COMPLETED
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Dermira, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Eligibility Criteria
Inclusion
- Male or female, 18 years or older.
- Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
- Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
- ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
Exclusion
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
- Treatment with:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
- Dupilumab within 3 months prior to baseline visit.
- Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
- Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
- Use of prescription moisturizers within 7 days of the baseline visit.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03443024
Start Date
January 30 2018
End Date
May 23 2019
Last Update
May 4 2021
Active Locations (58)
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1
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States, 85255
2
Dermatology Trial Associates
Bryant, Arkansas, United States, 72022
3
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
4
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538