Switching to Omlyclo® (omalizumab biosimilar) for adults with chronic spontaneous urticaria or severe allergic asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ROLL'YN-OMA is a real-world observational follow-up of adults with chronic spontaneous urticaria or severe allergic (severe) asthma who are stable on the reference omalizumab and are switched to the biosimilar Omlyclo® by their treating specialist. Eligible participants must have received the reference omalizumab for at least six months and been clinically controlled or in remission for at least three months before the switch. The protocol records clinical disease control or remission at 12 months and patient satisfaction at 6 and 12 months without assigning treatment—data are collected during routine care. The study is sponsored by Celltrion HealthCare France and is conducted at CHU Montpellier in France.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Salim BENKHALIFA, MD
• Email: rollyn-oma@sanoia.com
• Phone: +33 1 71 25 27 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.