Clinical trial NCT06863961: A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Atopic Dermatitis
Official title: A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: 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
timeFrame: At Week 16 and Week 32
measure: Percentage of Participants who Achieve EASI-75 Response at Week 32
timeFrame: At Week 32
measure: Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32
timeFrame: At Week 16 and Week 32
measure: Percent Change from Baseline in EASI by Visit
timeFrame: Baseline up to end of study (approximately 1 year)
measure: Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit
timeFrame: Baseline up to end of study (approximately 1 year)
measure: Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit
timeFrame: Baseline, weeks 4, 10, 16, 22 and 32
measure: Percentage of EASI-75 Responders at Week 16
timeFrame: At Week 16
measure: Percentage of Participants with Adverse Events
timeFrame: Baseline up to end of study (approximately 1 year)
measure: Serum Concentration of RO7790121 at Specified Timepoints
timeFrame: Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associate
state: California
city: Miami
country: United States
facility: Suncoast Research Associates LLC - ERN - PPDS
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: Dermatology Affiliates Research Institute, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Res LLC
state: Indiana
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Hoboken
country: United States
facility: Care Access Research - Hoboken
state: New Jersey
city: Camp Hill
country: United States
facility: Best Skin Research LLC
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Goodlettsville Dermatology Research
state: Tennessee
city: Hermitage
country: United States
facility: Cumberland Skin Center for Clinical Research LLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dallas
country: United States
facility: Reveal Research Institute
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: