Recruiting
Phase 3

Rozanolixizumab

Sponsor:

UCB Biopharma SRL

Code:

NCT07465289

Conditions

Ocular Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rozanolixizumab

Study Details

Brief 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.

Conditions

Ocular Myasthenia Gravis

Study ID

NCT07465289

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Jan 23, 2031

Anticipated

Primary completion date

Jan 23, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rozanolixizumab

The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle.

A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.

Interventions

Rozanolixizumab

Rozanolixizumab will be administered by subcutaneous infusion.

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
  • Incidence of treatment-emergent serious adverse events (TESAEs) [ Time Frame: Up to 2 years ]
  • Incidence of TEAEs leading to permanent withdrawal of study treatment [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

UCB Cares

+18445992273ucbcares@ucb.com

UCB Cares

00184459922733 (UCB)ucbcares@ucb.com

Locations

Mg0039 10103

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Phase 3
  • oMG
  • rozanolixizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.