Long-term afimkibart treatment for atopic dermatitis
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
We're testing whether long-term afimkibart is safe and keeps working in people with atopic dermatitis who already responded in an earlier trial.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 14 sites (Alpharetta, Georgia and 13 other locations) |
| Trial ID | NCT07223697 on ClinicalTrials.gov |
What this trial studies
This extension enrolls participants with atopic dermatitis who completed the parent afimkibart trial (CS45570) and achieved at least a 50% improvement in EASI by Week 36. Enrolled participants will continue to receive afimkibart and be followed for long-term safety, pharmacokinetics, and effectiveness using measures including EASI, IGA, DLQI, and POEM. Safety monitoring includes adverse event reporting, laboratory tests, and immunogenicity assessments. The trial is conducted at several U.S. dermatology research centers and requires adherence to scheduled visits and sample collections.
Who should consider this trial
Good fit: Ideal candidates are participants from the parent CS45570 trial who were still being followed at Week 36, achieved at least EASI50 from baseline, and can comply with ongoing visits and sample collections.
Not a fit: Patients who permanently discontinued afimkibart in the parent trial, withdrew consent, have other skin conditions that interfere with assessment, or have a history of severe allergic reactions to biologics are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could show that afimkibart provides sustained symptom control with an acceptable long-term safety profile for responders.
How similar studies have performed: Long-term extension programs of other biologic therapies for atopic dermatitis have often shown maintained benefit and acceptable safety, but afimkibart's long-term profile remains less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study Parent Clinical Trial-Specific Criteria: * Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\> EASI50 response from study baseline Exclusion Criteria: * Evidence of other skin conditions that would interfere with the assessment of AD * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
Where this trial is running
Alpharetta, Georgia and 13 other locations
- Hamilton Research, LLC — Alpharetta, Georgia, United States (Recruiting)
- Revival Research Institute, LLC — Troy, Michigan, United States (Recruiting)
- Best Skin Research LLC — Camp Hill, Pennsylvania, United States (Recruiting)
- Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A — Rio de Janeiro, Brazil (Recruiting)
- DermEffects — London, Ontario, Canada (Recruiting)
- DermEdge — Mississauga, Ontario, Canada (Recruiting)
- Dermatologikum Hamburg Gemeinschaftspraxis GbR — Hamburg, Germany (Recruiting)
- Centrum Medyczne Pratia Katowice I — Katowice, Silesian Voivodeship, Poland (Recruiting)
- Centrum Medyczne Pratia Gdynia — Gdynia, Poland (Recruiting)
- Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski — Krakow, Poland (Recruiting)
- Centrum Nowoczesnych Terapii "Dobry Lekarz" — Krakow, Poland (Recruiting)
- Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie — Rzeszów, Poland (Recruiting)
- Klinika Ambroziak Dermatologia — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: CS45943 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.