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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: RO7790121; 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 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: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-05-07
• Study Completion: 2026-11-19

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
RO7790121 Group I	RO7790121	Participants will receive RO7790121 via subcutaneous (SC) injection.
RO7790121 Group II	RO7790121	Participants will receive RO7790121 via SC injection.
RO7790121 Group III	RO7790121	Participants will receive RO7790121 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 RO7790121 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 (7)

Goodlettsville Dermatology Research; 🇺🇸 Goodlettsville, Tennessee, United States

Reveal Research Institute; 🇺🇸 Dallas, Texas, United States

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

Dawes Fretzin Clinical Res LLC; 🇺🇸 Indianapolis, Indiana, United States

Revival Research Institute, LLC; 🇺🇸 Troy, Michigan, United States

Best Skin Research LLC; 🇺🇸 Camp Hill, Pennsylvania, United States

Arlington Research Center; 🇺🇸 Arlington, Texas, United States