RecruitingNCT07425639

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

ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire

Sponsor

Celltrion HealthCare France

Enrollment

225 participants

Start Date

Oct 2, 2025

Study Type

OBSERVATIONAL

Conditions

Chronic Spontaneous Urticaria (CSU)Allergic Asthma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study (ROLL'YN-OMA) is following patients with severe asthma or chronic hives (chronic spontaneous urticaria) who have already been switched from the original omalizumab medication to a biosimilar version called Omlyclo. Researchers want to track how well the biosimilar works over time. **You may be eligible if...** - You are 18 years old or older - You have severe asthma or chronic spontaneous urticaria - You have been on the original omalizumab for at least 6 months before switching to Omlyclo - Your condition has been stable and well-controlled for at least 3 months before switching **You may NOT be eligible if...** - You have not previously been treated with the reference omalizumab drug - Your condition is not being managed by a specialist - You do not meet disease-specific stability criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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