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

Sponsor
Celltrion HealthCare France
Study ID
NCT07425639
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: CSU group
    Switch from omalizumab originator in patients with CSU
  • Arm: Allergic asthma group
    Switch from omalizumab originator in patients with allergic asthma

Primary Outcome Measure

Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment. [ Time Frame: 12 months ]

Central Contacts

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