Trials Today

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.	Drug: RO7790121 RO7790121 will be administered as SC injection. Other names: PF-06480605 RVT-3101
Experimental RO7790121 Group II	Participants will receive RO7790121 via SC injection.	Drug: RO7790121 RO7790121 will be administered as SC injection. Other names: PF-06480605 RVT-3101
Experimental RO7790121 Group III	Participants will receive RO7790121 via SC injection.	Drug: RO7790121 RO7790121 will be administered as SC injection. Other names: PF-06480605 RVT-3101
Placebo Comparator Placebo	Participants will receive placebo via SC injection.	Drug: Placebo Placebo will be administered as SC injection.

Recruiting Locations

Dermatology Research Associate
Los Angeles, California 90045

Suncoast Research Associates LLC - ERN - PPDS
Miami, Florida 33173

Hamilton Research, LLC
Alpharetta, Georgia 30022

Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia 30305

Dawes Fretzin Clinical Res LLC
Indianapolis, Indiana 46250

Revival Research Institute, LLC
Troy, Michigan 48084

Care Access Research - Hoboken
Hoboken, New Jersey 07030

Best Skin Research LLC
Camp Hill, Pennsylvania 17011

Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072

Cumberland Skin Center for Clinical Research LLC
Hermitage, Tennessee 37076

Arlington Research Center
Arlington, Texas 76011

Modern Research Associates
Dallas, Texas 75231

Reveal Research Institute
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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.