Actively Recruiting
An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials
Led by Hoffmann-La Roche · Updated on 2026-05-11
120
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of Afimkibart (also called RO7790121) in adults who have atopic dermatitis and previously took part in earlier Afimkibart clinical trials. This Phase 2 extension study focuses on participants who responded to Afimkibart in the parent study and continued follow-up through the Week 36 visit. Participants will receive Afimkibart as subcutaneous injections following a schedule defined in the study protocol. Both study groups receive the same treatment to monitor ongoing effects over a period of up to six years. This extension allows researchers to collect long-term data on the medication’s impact on eczema severity and quality of life. During the study, participants will complete various assessments including the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Dermatology Life Quality Index (DLQI), and Participant-Oriented Eczema Measure (POEM). Blood samples will be collected to measure Afimkibart levels and antibody responses at multiple timepoints. Safety will be closely monitored by tracking adverse events from baseline through up to six years of follow-up.
CONDITIONS
Brief Title
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to comply with all study procedures including efficacy assessments (EASI and IGA), outcome instruments (DLQI, POEM), and safety and pharmacokinetic sample collections throughout the study
- Participants from the parent clinical trial CS45570 who were evaluated at Week 36 follow-up and achieved at least a 50% improvement in eczema severity from baseline
You will not qualify if you...
- Presence of other skin conditions that would interfere with assessing atopic dermatitis
- Withdrawal of consent or early discontinuation from the parent study
- Permanent discontinuation of study drug in the parent study
- History of severe allergic or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years
Participants receive Afimkibart as subcutaneous injections as per the study schedule and are monitored for safety and efficacy.
Periodic visits for dosing and assessments over up to 6 years
Trial Site Locations
Total: 14 locations
1
Hamilton Research, LLC
Alpharetta, Georgia, United States, 30022
Actively Recruiting
2
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
3
Best Skin Research LLC
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
4
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
5
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Brazil, 20241-180
Actively Recruiting
6
DermEffects
London, Ontario, Canada, N6H 5L5
Actively Recruiting
7
DermEdge
Mississauga, Ontario, Canada, L4Y4C5
Actively Recruiting
8
Dermatologikum Hamburg Gemeinschaftspraxis GbR
Hamburg, Germany, 20354
Actively Recruiting
9
Centrum Medyczne Pratia Katowice I
Katowice, Silesian Voivodeship, Poland, 40-081
Actively Recruiting
10
Centrum Medyczne Pratia Gdynia
Gdynia, Poland, 81-338
Actively Recruiting
11
Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski
Krakow, Poland, 30-002
Actively Recruiting
12
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Poland, 31-011
Actively Recruiting
13
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
Rzeszów, Poland, 35-055
Actively Recruiting
14
Klinika Ambroziak Dermatologia
Warsaw, Poland, 02-953
Actively Recruiting
Research Team
R
Reference Study ID Number: CS45943 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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