A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Atopic Dermatitis
Purpose
The purpose of this study is to assess the efficacy and safety of RO7790121 in participants with moderate to severe atopic dermatitis (AD).
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening - Moderate to severe AD - At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study
Exclusion Criteria
- Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis - IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study - Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study - Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline - Acquired or congenital immunodeficiency - Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental RO7790121 Group I |
Participants will receive RO7790121 via subcutaneous (SC) injection. |
|
Experimental RO7790121 Group II |
Participants will receive RO7790121 via SC injection. |
|
Experimental RO7790121 Group III |
Participants will receive RO7790121 via SC injection. |
|
Placebo Comparator Placebo |
Participants will receive placebo via SC injection. |
|
Recruiting Locations
Los Angeles, California 90045
Miami, Florida 33173
Alpharetta, Georgia 30022
Atlanta, Georgia 30305
Indianapolis, Indiana 46250
Troy, Michigan 48084
Hoboken, New Jersey 07030
Camp Hill, Pennsylvania 17011
Goodlettsville, Tennessee 37072
Hermitage, Tennessee 37076
Arlington, Texas 76011
Dallas, Texas 75231
Dallas, Texas 75235
More Details
- NCT ID
- NCT06863961
- Status
- Recruiting
- Sponsor
- Hoffmann-La Roche
Study Contact
Reference Study ID Number: CS45570 https://forpatients.roche.com/888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com