Clinical Trial

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

Study acronym: ROLL'YN-OMA
Recruiting
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Summary
ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.
Trial Details
NCT Number NCT07425639
Lead Sponsor Celltrion HealthCare France
Conditions Chronic Spontaneous Urticaria (CSU), Allergic Asthma
Enrollment 225 participants
Start Date 2025-10-02
Primary Completion 2028-03 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-23