ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar (ROLL'YN-OMA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Asthma; Chronic Spontaneous Urticaria (CSU)
• Intervention / Treatment: Drug: Omalizumab

Detailed Description

Biotherapies have revolutionized the management of chronic inflammatory diseases in gastroenterology (Crohn's disease and ulcerative colitis), dermatology (plaque psoriasis or chronic urticaria, for example), and even, more recently, in pulmonology (severe asthma). However, due to their specificity and complexity, these treatments have a high cost that significantly impacts healthcare systems.

Following the loss of patent protection for these reference biotherapies, biosimilars were developed. These are similar to the reference molecules, but not strictly identical. As a result, to obtain marketing authorization, a biosimilar must demonstrate equivalence to the reference biologic in terms of efficacy and safety in a single indication defined in a Phase I (pharmacokinetic) and Phase III (clinical) study, before being extrapolated to other indications, as applicable.

The main objective of biosimilars is to reduce the costs associated with treatment and ease the pressure on healthcare systems, enabling more patients to be treated. Having already demonstrated bioequivalence during the preauthorization development phases, once marketed, two major subjects remain for patients and healthcare professionals regarding the real-world use of biosimilars: maintaining efficacy after switching from the reference biologic, and patient satisfaction. In short, ensuring there is no opportunity cost for patients taking biosimilars. In addition, European learned societies such as ECCO (European Crohn's and Colitis Organization) and EULAR (European Alliance of Associations for Rheumatology) have stated that switching from the reference biologic to a biosimilar is acceptable when not contraindicated. Furthermore, international patient associations such as the IFPA (International Federation of Psoriasis Associations) welcome the introduction of safe and effective biosimilars, which could improve access to treatment and broaden therapeutic options for patients. This study aims to answer these questions for OMLYCLO® (CT-P39), a biosimilar omalizumab approved by the European Commission on May 16, 2024, through a centralized procedure. OMLYCLO® is indicated for allergic asthma in children, adolescents, and adults, as well as for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older.

Although these conditions are different, the principle is the same. Physicians switch patients who are controlled or in clinical remission, regardless of the condition, with a common goal: maintaining this control or clinical remission after the switch. This aims to demonstrate that there is no loss of opportunity for patients treated with a biosimilar, while ensuring good patient acceptability and satisfaction within the framework of shared decision-making.

ROLL'YN-OMA (Cohort for the management of chronic inflammatory diseases in a national observational study of patients treated by OMLYCLO®, an OMAlizumab biosimilar) 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.

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

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

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • CHU Montpellier
    • Contact: Arnaud Bourdin, MD, PhD; Phone Number: +33 4 67 33 60 96; Email: a-bourdin@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult dermatology or pulmonology patients presenting a diagnosis for any of the following pathologies: - CSU - Allergic Asthma

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CSU group; Switch from omalizumab originator in patients with CSU	Drug: Omalizumab; omalizumab biosimilar
Allergic asthma group; Switch from omalizumab originator in patients with allergic asthma	Drug: Omalizumab; omalizumab biosimilar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment.	Patients still controlled or in clinical remission 12 months after initiation of biosimilar treatment, according to the definitions used at base	12 months

Collaborators and Investigators

• Sponsor: Celltrion HealthCare France

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Anti-Idiotypic; Omalizumab
• Other Study ID Numbers: CTHC-CTP39-3; 2025-A00875-44 (Other Identifier: Ethics Committee Ile de France III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No