Study to evaluate 6-week treatment cycles of rozanolixizumab in study participants with gMG.

Enrolling By Invitation
18-99 years
All
Phase 3
4 participants needed
1 Location

Brief description of study

The research study is being conducted to test the long-term safety, tolerability and effectiveness of rozanolixizumab in adult patients with generalized myasthenia gravis (MG) who have already taken part in the MG0003 study and is intended to replace MG0004. This study will evaluate 6-week treatment cycles of rozanolixizumab in study participants with gMG. If you agree to join the study, you will be asked to complete the following research procedures: • Take rozanolixizumab over an initial 6-week treatment cycle and then as needed based on worsening of gMG symptoms. • Provide blood and urine samples during study visits. • Undergo health checks, physical and motor assessments during study visits. Your participation will continue until rozanolixizumab is approved or until study participants transition to a managed access program (MAP), if available through the Sponsor and according to local guidance. Participants for this study must have already participated in the MG0003 study. Participants will not be paid to take part in this study. However, they will be reimbursed up to $50 per study visit, for travel expenses to and from the hospital for completed visits.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: gMG myasthenia gravis
  • Age: Between 18 Years - 99 Years
  • Gender: All
Updated on 01 Aug 2024. Study ID: 848406
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Office of Clinical Research