RELIEVE, a Clinical Trial for Myasthenia Gravis

04 Aug RELIEVE, a Clinical Trial for Myasthenia Gravis

We are inviting adults aged 18-75 living with generalized Myasthenia Gravis (gMG) who are on stable standard-of-care treatment to participate in a Phase III clinical trial evaluating remibrutinib, an oral medication.

RELIEVE is a clinical trial is testing the effectiveness and safety of remibrutinib for adults living with generalized Myasthenia Gravis. The first stage of the trial will be a double-blind Core Treatment period where participants will be randomly assigned to receive either remibrutinib or placebo for 6 months. This will be followed by an Open-Label Extension period where participants will be able to continue remibrutinib (or start receiving it if previously on placebo) for up to 60 months.

During the trial, there will be clinic visits at the UW Medical Center involving various clinical assessments and questionnaires. There is no cost for study medication or study-related care, and reimbursement for travel will be provided.

Approximately 180 participants will be enrolled across multiple centers internationally. Join us in advancing treatment options for Myasthenia Gravis.

Participant Eligibility

We would be pleased to consider you for this study if you are:
• An adult between the ages of 18-75 years with a confirmed diagnosis of MGFA Class II-IV gMG
• Have documented positive serologic testing for AChR+ antibody or MuSK+ antibody, OR seronegative for both AChR and MuSK antibodies
• Able to safely swallow study medication
• Currently on a stable dose of standard-of-care treatment for Myasthenia Gravis (Note: you must continue to take your regular gMG medication for the duration of the study)

We are unable to consider you for this study if you:
• Have been treated with:
~ intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month
~ rituximab in the past 6 months
~ ravulizumab or other complement inhibitors in the past 3 months
~ efgartigimod or other anti-FcRn therapies in the past 3 months

• Have received any live vaccines (varicella-zoster virus or measles, oral polio, nasal influenza) within 6 weeks of treatment with the study medication
• Have had a thymectomy in the past 6 months or a planned thymectomy at any point during the study
• Have had a splenectomy
• Have a major disease in addition to gMG (hepatic disease, HIV, severe kidney disease, advanced cardiac disease, severe pulmonary disease, or a serious gastric disorder)
• Have a history of another autoimmune condition in addition to gMG (thyroiditis, rheumatoid arthritis, etc.)
• Have a history of ongoing drug or alcohol abuse that could interfere with your participation in the study
• Have worsening muscle weakness related to current infections or medications
• Are pregnant, nursing, or are intending to become pregnant
• Are participating in any other investigational drug study

Other protocol-defined inclusion/exclusion criteria may apply

Contact

Kaycie Opiyo
(206) 616-3132