NCT07425639

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: Celltrion HealthCare France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Spontaneous Urticaria (CSU)
• Allergic Asthma

Interventions

Type	Name	Description
DRUG	Omalizumab	omalizumab biosimilar

Timeline

• Start date: 2025-10-02
• Primary completion: 2028-03-01
• Completion: 2028-09-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: France