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Clinical Trials in Spain / NCT07465289
Recruiting Phase 3

A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

NCT07465289 · tracked via the Priya Life Science Spain tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2026-09-16
Last updated
2026-09-24

Condition(s) studied

Ocular Myasthenia Gravis

Investigational drug(s) / intervention(s)

Rozanolixizumab →

Rozanolixizumab: Rozanolixizumab will be administered by subcutaneous infusion.

Study summary

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF) * Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038 * Participant for whom the investigator considers a favorable benefit/risk for participation * Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator * Male or female * A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance for the entire study period * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol Exclusion Criteria: * Participant meets any of the withdrawal criteria defined in MG0038 * Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry. * Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab * Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies * Participant has planned use of prohibited medications

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years
    Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.
  • Incidence of treatment-emergent serious adverse events (TESAEs) — Up to 2 years
    An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
  • Incidence of TEAEs leading to permanent withdrawal of study treatment — Up to 2 years
    Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.

Trial sites (7)

FacilityCityRegionStatus
Mg0039 10103 Columbus Ohio Recruiting
Mg0039 31901 Beijing China Recruiting
Mg0039 31907 Nanchang China Recruiting
Mg0039 31902 Suzhou China Recruiting
Mg0039 31802 Kobe Japan Recruiting
Mg0039 20604 Barcelona Spain Recruiting
Mg0039 20611 Madrid Spain Recruiting

More UCB Biopharma SRL trials in Spain

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) Recruiting
A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy Active, not recruiting
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus Enrolling by invitation
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis Recruiting
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465289 on ClinicalTrials.gov ↗ ← All trials in Spain