NCT07223697 · Hoffmann-La Roche
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
(Velarite-LTE)
What this study is about
This study will assess long-term safety and effectiveness of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
View original scientific description
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
Interventions
DRUG
Afimkibart
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Primary outcome measures
Percentage of Participants with Adverse Events
Time frame: From Baseline up to 6 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Alpharetta, Georgia
- Troy, Michigan
- Camp Hill, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations