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Trial of rocatinlimab in adult and adolescent subjects with moderate to severe atopic dermatitis (AD)
THE STUDY IS DESIGNED TO CONFIRM WHETHER ROCATINLIMAB IS SAFE AND EFFECTIVE FOR TREATING PATIENTS WITH MODERATE TO SEVERE AD WHO HAVE NOT RESPONDED TO TOPICAL (APPLIED EXTERNALLY TO THE SKIN) OR OTHER TREATMENTS AND WHETHER IT IS WELL TOLERATED AND CAUSES ANY SIDE EFFECTS. IT WILL ALSO HELP ESTABLISH THE BENEFICIAL IMPACT OF ROCATINLIMAB TREATMENT ON RELATED OUTCOMES, INCLUDING SKIN ITCHING, SKIN PAIN, SLEEP DEPRIVATION AND IMPAIRED QUALITY OF LIFE IN PARTICIPANTS WITH AD.
Technical Summary
- PHASE 3, MULTICENTER, DOUBLE-BLIND MAINTENANCE STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF ROCATINLIMAB IN ADULT AND ADOLESCENT SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (AD). IMMUNOTHERAPY
- Code EudraCT: 2022-501587-17-00
- Protocol number: 20210146
- Promoter: Amgen, S.A.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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