MG0004: A randomized open-label extension study to investigate the long-term safety tolerability and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis

MG0004: A randomized open-label extension study to investigate the long-term safety tolerability and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis
Recruiting
99 years or below
All
Phase 3
4 participants needed
1 Location

Brief description of study

Rozanolixizumab is a humanized IgG4 monoclonal antibody that is being developed as an inhibitor of the activity of the neonatal Fc receptor (FcRn) for IgG. By blocking the activity of neonatal FcRn, rozanolixizumab accelerates the catabolism of antibodies and reduces the serum IgG concentration, including pathogenic IgG in MG patients, thus offering a potentially safe, effective, and convenient alternative to existing treatments.

This Phase 3 study (MG0003) is underway to provide the required data to establish the efficacy and safety of rozanolixizumab inanti-AChR or anti-MuSK autoantibody-positive patients with generalized MG who experience moderate to severe symptoms and are being considered for additional treatment with IVIg or plasma exchange (PEX).MG0004 is a Phase 3 open-label extension study to evaluate the long-term safety, tolerability, and efficacy of rozanolixizumab with a weekly dosing regimen for 52 weeks in study participants with generalized MG.

The MG0004 open-label extension study will provide the opportunity to assess the long-term safety of rozanolixizumab in study participants with MG who participated in MG0003 and will provide them with a chance to benefit from long-term treatment.

If you agree to join the study, you will be asked to complete the following research procedures: • Take rozanolixizumab once per week for about 1 year. • Provide blood and urine samples during study visits. • Undergo health checks, physical and motor assessments during study visits. Your participation will last for about 15 months.

Eligibility of study

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

  • Conditions: myasthenia gravis
  • Age: 99 years or below
  • Gender: All


Updated on 04 Aug 2024. Study ID: 834252

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