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

Conditions

• Allergic Asthma
• Chronic Spontaneous Urticaria (CSU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  omalizumab biosimilar

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

First listed

Feb 23, 2026

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

• Salim BENKHALIFA, MD
  +33 1 71 25 27 00
  [email protected]

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