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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Afimkibart; Drug: Placebo

• Registration Number: NCT06863961
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Study Start: 2025-04-01
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-07-13
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afimkibart Group I	Afimkibart	Participants will receive afimkibart via subcutaneous (SC) injection.
Afimkibart Group II	Afimkibart	Participants will receive afimkibart via SC injection.
Afimkibart Group III	Afimkibart	Participants will receive afimkibart via SC injection.
Placebo	Placebo	Participants will receive placebo via SC injection.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16	Baseline and Week 16

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32	At Week 16 and Week 32
Percentage of Participants who Achieve EASI-75 Response at Week 32	At Week 32
Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32	At Week 16 and Week 32
Percent Change from Baseline in EASI by Visit	Baseline up to end of study (approximately 1 year)
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit	Baseline up to end of study (approximately 1 year)
Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit	Baseline, weeks 4, 10, 16, 22 and 32
Percentage of EASI-75 Responders at Week 16	At Week 16
Percentage of Participants with Adverse Events	Baseline up to end of study (approximately 1 year)
Serum Concentration of Afimkibart at Specified Timepoints	Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.

Trial Locations

Locations (43)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Regents of the University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

DRK Krankenhaus Chemnitz-Rabenstein; 🇩🇪 Chemnitz, Saxony, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Emilia-Romagna, Italy

Dermatology Research Associate; 🇺🇸 Los Angeles, California, United States

Suncoast Research Associates LLC - ERN - PPDS; 🇺🇸 Doral, Florida, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

Hamilton Research, LLC; 🇺🇸 Alpharetta, Georgia, United States

Dermatology Affiliates Research Institute, LLC; 🇺🇸 Atlanta, Georgia, United States

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