A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

ArmDescriptionAssigned Intervention
Experimental
Afimkibart Group I 		Participants will receive afimkibart via subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RO7790121
Experimental
Afimkibart Group II 		Participants will receive afimkibart via SC injection.
  • Drug: Afimkibart
    Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RO7790121
Experimental
Afimkibart Group III 		Participants will receive afimkibart via SC injection.
  • Drug: Afimkibart
    Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RO7790121
Placebo Comparator
Placebo 		Participants will receive placebo via SC injection.
  • Drug: Placebo
    Placebo will be administered as SC injection.

Recruiting Locations

University of California Los Angeles
Los Angeles 5368361, California 5332921 90024

Dermatology Research Associate
Los Angeles 5368361, California 5332921 90045

Suncoast Research Associates LLC - ERN - PPDS
Doral 4153471, Florida 4155751 33172

Olympian Clinical Research
Tampa 4174757, Florida 4155751 33615

Hamilton Research, LLC
Alpharetta 4179574, Georgia 4197000 30022

Dermatology Affiliates Research Institute, LLC
Atlanta 4180439, Georgia 4197000 30305

Dawes Fretzin Clinical Res LLC
Indianapolis 4259418, Indiana 4921868 46250

Revival Research Institute, LLC
Troy 5012639, Michigan 5001836 48084

Regents of the University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455

Care Access Research - Hoboken
Hoboken 5099133, New Jersey 5101760 07030

Weill Cornell Medicine
New York 5128581, New York 5128638 10075

Centricity Research Dublin
Dublin 5152333, Ohio 5165418 43016

DOCS Clinical Research - Springfield
Springfield 4525353, Ohio 5165418 45505

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239

Best Skin Research LLC
Camp Hill 5182928, Pennsylvania 6254927 17011

Goodlettsville Dermatology Research
Goodlettsville 4625282, Tennessee 4662168 37072

Cumberland Skin Center for Clinical Research LLC
Hermitage 4628929, Tennessee 4662168 37076

Arlington Research Center
Arlington 4671240, Texas 4736286 76011

Modern Research Associates
Dallas 4684888, Texas 4736286 75231

Reveal Research Institute
Dallas 4684888, Texas 4736286 75235

Care Access Research - Arlington
Arlington 4744709, Virginia 6254928 22206

More Details

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