MG0003:A Phase 3 study of rozanolixizumab in myasthenia gravis.

• Research type

  Research Study

• Full title

  A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.

• IRAS ID

  264362

• Contact name

  Pradnya Lokhande

• Contact email

  pradnya.lokhande@parexel.com

• Sponsor organisation

  UCB BIOPHARMA SPRL

• Eudract number

  2019-000968-18

• Clinicaltrials.gov Identifier

  NCT03971422

• Clinicaltrials.gov Identifier

  132407, IND number

• Duration of Study in the UK

  1 years, 0 months, 3 days

• Research summary

  Myasthenia gravis (MG) is a serious debilitating condition which causes muscle weakness, tiredness. In MG some types of cells, IgG or antibodies (body proteins) that normally fight infections, go wrong, and affect the communication between nerves and muscles which results in the muscle weakness and tiredness.
  Several commonly available treatment currently in the market acts by reducing the concentration of abnormal IgG autoantibodies in the blood.
  Rozanolixizumab is a molecule which works by increasing the break down of IgG. This reduces the total level of IgG including the disease-causing antibodies. By reducing the level of antibodies, it is postulated that the disease will get better controlled.
  In this study, we want to see if rozanolixizumab is effective in improving the MG symptoms; how safe and tolerable rozanolixizumab is; how rozanolixizumab acts in the body; how the body reacts to rozanolixizumab; and to measure the amount of rozanolixizumab in the body.
  Participants will be randomly assigned to 1 of 3 treatments. Participants will either receive 7mg/kg rozanolixizumab or 10 mg/kg rozanolixizumab or a placebo dose. Neither the participant nor the study doctor will know whether they are given rozanolixizumab or placebo.
  The study will last for up to 18 weeks, including a Screening Period of up to 4 weeks before the first dose of study drug, Treatment Period of 6 weeks, and Observation Period of 8 weeks.
  Sponsor is UCB Biopharma SPRL. Approximately 240 participants will be enrolled at up to 100 sites from North America and Europe. Only those participants who meet certain eligibility criteria will receive the study drug.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  19/WM/0234

• Date of REC Opinion

  14 Nov 2019

• REC opinion

  Further Information Favourable Opinion