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

Inclusion Criteria10

Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria
Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).
Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \< 1.5 and FEV1 ≥ 80% of the patient's most recent values/ Chronic Spontaneous Urticaria : UCT ≥ 12
For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).
Be able to start treatment within a maximum of 60 days following inclusion.
Have an email address.
Have a mobile phone number.
Be able to understand and complete questionnaires in French.
Not object to participating in the study.
Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme

Exclusion Criteria4

Patients under guardianship or trusteeship, or otherwise deprived of liberty.
Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.
Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.
Contraindication to the study products.