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RecruitingPhase 3

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

UCB Biopharma SRL · NCT07465289

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
100
US sites recruiting
1
Study start
September 16, 2026
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Rozanolixizumab

Conditions: Ocular Myasthenia Gravis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • UCB Cares · +18445992273 · ucbcares@ucb.com
  • UCB Cares · 00184459922733 (UCB) · ucbcares@ucb.com
A Study to Evaluate The Long-Term Safety And Efficacy of… (NCT07465289) | Bored Studies