NCT07425639Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 225 (estimated)
- First submitted
- 16 Feb 2026
- Start date
- 2 Oct 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Celltrion HealthCare France
- Diseases
- Asthma
- NCT number
- NCT07425639
What you commit to
- Study type: Observational
- Planned participants: 225
- From 2 Oct 2025 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.
Other
- Patients under guardianship or trusteeship, or otherwise deprived of liberty.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.