RELIEVE

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety, and tolerability of remibrutinib in patients with generalized Myasthenia Gravis, followed by an open-label extension phase

• IRAS ID

  1012403

• Contact name

  Fiona Morris

• Contact email

  fiona.morris@novartis.com

• Sponsor organisation

  Novartis Pharmaceuticals UK Limited

• Clinicaltrials.gov Identifier

  NCT06744920

• Research summary

  The purpose of this Phase 3, randomized, double-blind, placebo-controlled, multicenter study is to find out whether remibrutinib treatment is safe, well tolerated and effective in patients with generalised Myasthenia Gravis, who are on stable dose of standard of care treatment. The sponsor conducting this study is Novartis Pharma AG.
  
  Generalised Myasthenia gravis is a rare autoimmune neuromuscular condition where antibodies damage the signals between nerves and muscles, causing muscle weakness and tiredness. Remibrutinib blocks a specific part of the immune system called Bruton’s tyrosine kinase (BTK), which will help reduce this harmful immune activity. This can help lower muscle weakness and improve systems.

  The study is split into two parts: A Core part and an Extension part.

  Core Part includes screening period (up to 4 weeks), treatment period where participants will receive either remibrutinib or placebo for 6 months and a safety follow-up visit. The maximum length of the Core Part of the study is up to 7 months. Participants and their study doctor will not know which treatment they are assigned to except in an emergency.

  After completing the Core Part of the study, participants who are eligible will continue into an open label extension part for up to 60 months, followed by another safety follow-up visit. All participants will receive remibrutinib in the open label extension part.
  At the study visits, the following procedures will take place: blood pressure and pulse measurement, physical examination, recording of any change in medications, recording of any side effects, ECG, blood and urine collection, swallowing test, pregnancy test, completion of questionnaires, study treatment dispensing.

  Approximately 180 participants between the ages of 18 and 75 years will participate in this study across the globe.

• REC name

  London - Central Research Ethics Committee

• REC reference

  25/LO/0884

• Date of REC Opinion

  13 Feb 2026

• REC opinion

  Further Information Favourable Opinion