Recruiting
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
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.
ClinicalTrials.gov IDNCT07425639
PhaseNot Applicable
Enrollment225
SponsorCelltrion HealthCare France
Age18 Years
SexALL
Conditions studied
Chronic Spontaneous Urticaria (CSU), Allergic Asthma
About this study
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.
Interventions
- Drug: Omalizumab — omalizumab biosimilar
Primary outcomes
- Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment. (12 months)
Eligibility information
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 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.
Study locations
- CHU Montpellier, Montpellier, France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.