A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2019-05-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.; Eli Lilly and Company
• Collaborator: Dermira, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.