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

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

This will try switching adults who are stable on reference omalizumab to the biosimilar Omlyclo® to see if disease control and patient satisfaction stay the same over 12 months.

Quick facts

• Study type: Observational
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Celltrion HealthCare France (industry)
• Drugs / interventions: omalizumab
• Locations: 1 site (Montpellier)
• Trial ID: NCT07425639 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with chronic spontaneous urticaria or severe allergic asthma who have been on reference omalizumab ≥6 months and clinically stable for ≥3 months, and whose specialist has independently decided to switch to Omlyclo®.

Not a fit: Patients who are not clinically stable, who have been on the reference drug for less than six months, who are under 18, or who have contraindications/intolerance to omalizumab are unlikely to benefit from this switch-focused observation.

Why it matters

Potential benefit: If successful, the switch could maintain disease control while expanding access and reducing treatment costs through use of a lower-cost biosimilar.

How similar studies have performed: Switching studies for other biologic biosimilars have generally shown maintained efficacy and safety, and early real-world reports for omalizumab biosimilars are limited but reassuring.

Eligibility criteria

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 this trial is running

Montpellier

• CHU Montpellier — Montpellier, France (RECRUITING)

Study contacts

• Study coordinator: Salim BENKHALIFA, MD

Conditions: Chronic Spontaneous Urticaria, Allergic Asthma