ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar (NCT07425639) | Clinical Trial Compass
RecruitingNot Applicable
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
France225 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* Patients under guardianship or trusteeship, or otherwise deprived of liberty.
* Pregnant women or women of childbearing potential with a desire to become pregnant du…
What they're measuring
1
Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment.