Study of Switching to Omlyclo4, an Omalizumab Biosimilar, in Adults with Severe Asthma or Chronic Spontaneous Urticaria to Maintain Disease Control and Satisfaction

What this Trial Is About

This research aims to evaluate the use of OMLYCLO4, a biosimilar version of omalizumab, in patients with chronic inflammatory diseases such as severe asthma and chronic spontaneous urticaria CSU. It focuses on patients who have been stable or in remission for at least three months while receiving standard biologic therapy and whose doctors have independently decided to switch them to this biosimilar. The main goal is to assess whether disease control or remission is maintained 12 months after starting OMLYCLO4 and to measure patient satisfaction at 6 and 12 months. Participants in the study will switch from the reference omalizumab treatment to OMLYCLO4 as part of their usual care. The study includes two groups one with patients having CSU and another with those having allergic asthma. Patients must start treatment within 60 days of inclusion. This is an observational study, meaning it monitors patients receiving the biosimilar without altering their treatment beyond the switch. During the study, patients will be asked to complete questionnaires in French and have access to email and mobile phones for communication. Researchers will track disease control or remission using specific activity scores for asthma and CSU. The primary outcome is maintaining disease control or remission 12 months after switching. Patient satisfaction will also be assessed at 6 and 12 months. The study will continue until September 2028, allowing long-term observation of biosimilar use in real-world settings.

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