Actively Recruiting
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Led by Celltrion HealthCare France · Updated on 2026-02-23
225
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older diagnosed with severe asthma or chronic spontaneous urticaria
- Treated with reference omalizumab for at least 6 months prior to inclusion
- Stable disease or in clinical remission for at least 3 months, as assessed by disease-specific activity scores
- Physician has decided to switch to OMLYCLO4 biosimilar on the day of inclusion
- Able to start biosimilar treatment within 60 days of inclusion
- Have an email address and mobile phone number
- Able to understand and complete questionnaires in French
- Agree to participate in the study
- Affiliated with or beneficiary of a French Social Security scheme
You will not qualify if you...
- Under guardianship, trusteeship, or deprived of liberty
- Pregnant or women of childbearing potential wishing to become pregnant during treatment
- Currently participating in another clinical trial prohibiting simultaneous study participation
- Contraindicated to the study products
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France
Actively Recruiting
Research Team
S
Salim BENKHALIFA, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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