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

NCT07425639 | Recruiting

• 2 other identifiers: CTHC-CTP39-32025-A00875-44
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Spontaneous Urticaria (CSU); Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CSU group

Switch from omalizumab originator in patients with CSU

Drug: Omalizumab

Allergic asthma group

Switch from omalizumab originator in patients with allergic asthma

Drug: Omalizumab

Interventions

Omalizumab DRUG

omalizumab biosimilar

Allergic asthma group; CSU group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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®.
• Contraindication to the study products.

Sponsors & Collaborators

• Celltrion HealthCare France: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Salim BENKHALIFA, MD

CONTACT

+33 1 71 25 27 00; rollyn-oma@sanoia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: October 2, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)