Rozanolixizumab for long-term safety and efficacy in adult ocular myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating Rozanolixizumab in adults with ocular myasthenia gravis. Participants have previously received at least one dose of Rozanolixizumab or placebo in a prior study and will be monitored for long-term safety and efficacy. The study design focuses on sustained treatment effects and ongoing safety outcomes, with adherence to a defined visit schedule. Locations include sites in Scottsdale, AZ; Columbus, OH; and Beijing, China, under the lead sponsor UCB Biopharma SRL. Eligibility requires adults 18+ who can provide informed consent and meet contraceptive or non-pregnant criteria as applicable.

Why it matters

Who can join: the full rules

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

Where it's running

• Mg0039 10104
  Scottsdale, Arizona, United States Recruiting
• Mg0039 10103
  Columbus, Ohio, United States Recruiting
• Mg0039 31901
  Beijing, China Recruiting
• Mg0039 31912
  Beijing, China Recruiting
• Mg0039 31908
  Chongqing, China Recruiting
• Mg0039 31907
  Nanchang, China Recruiting

Study contacts

• Study coordinator: UCB Cares
• Email: ucbcares@ucb.com
• Phone: +18445992273

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rozanolixizumab for adult ocular myasthenia gravis

  This trial tests Rozanolixizumab versus placebo to see if it helps adults with ocular myasthenia gravis see improvements in eye muscles with tolerable safety.

  Recruiting at 36 sites Phase 3 UCB Pharma · Scottsdale, Arizona and 35 other locations · NCT07463521

• Tracking Real-Life Myasthenia Gravis Symptoms in Patients on Rozanolixizumab

  This observational study follows adults with generalized myasthenia gravis who are treated with Rozanolixizumab to see how their symptoms and fatigue change in real life.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes-maritimes and 10 other locations · NCT07570589

• Immediate corticosteroids with rituximab as needed to stop ocular myasthenia from spreading

  We will test whether starting corticosteroids right away, and adding rituximab if eye symptoms come back, can prevent recent-onset ocular myasthenia from spreading to other muscles in adults.

  Recruiting at 6 sites Phase 3 Fondation Ophtalmologique Adolphe de Rothschild · Bordeaux and 10 other locations · NCT06342544

• Different immunosuppressants and treatments for new-onset ocular myasthenia gravis

  This project tries different immunosuppressants and symptomatic treatments to see which works best and is safest for adults with new-onset ocular myasthenia gravis.

  Recruiting Tang-Du Hospital · Xi'an, Shaanxi · NCT04182984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.