{"id":5919,"date":"2025-08-04T08:15:24","date_gmt":"2025-08-04T15:15:24","guid":{"rendered":"https:\/\/www.iths.org\/participate\/?p=5919"},"modified":"2025-08-04T08:15:24","modified_gmt":"2025-08-04T15:15:24","slug":"relieve-a-clinical-trial-for-myasthenia-gravis","status":"publish","type":"post","link":"https:\/\/www.iths.org\/participate\/relieve-a-clinical-trial-for-myasthenia-gravis\/","title":{"rendered":"RELIEVE, a Clinical Trial for Myasthenia Gravis"},"content":{"rendered":"
<\/div>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Approximately 180 participants will be enrolled across multiple centers internationally. Join us in advancing treatment options for Myasthenia Gravis.<\/p>\n

Participant Eligibility<\/h3>\n

We would be pleased to consider you for this study if you are:
\n\u2022 An adult between the ages of 18-75 years with a confirmed diagnosis of MGFA Class II-IV gMG
\n\u2022 Have documented positive serologic testing for AChR+ antibody or MuSK+ antibody, OR seronegative for both AChR and MuSK antibodies
\n\u2022 Able to safely swallow study medication
\n\u2022 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)<\/p>\n

We are unable to consider you for this study if you:
\n\u2022 Have been treated with:
\n~ intravenous immunoglobulins or plasma exchange (IVIg\/PLEX) in the past month
\n~ rituximab in the past 6 months
\n~ ravulizumab or other complement inhibitors in the past 3 months
\n~ efgartigimod or other anti-FcRn therapies in the past 3 months<\/p>\n

\u2022 Have received any live vaccines (varicella-zoster virus or measles, oral polio, nasal influenza) within 6 weeks of treatment with the study medication
\n\u2022 Have had a thymectomy in the past 6 months or a planned thymectomy at any point during the study
\n\u2022 Have had a splenectomy
\n\u2022 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)
\n\u2022 Have a history of another autoimmune condition in addition to gMG (thyroiditis, rheumatoid arthritis, etc.)
\n\u2022 Have a history of ongoing drug or alcohol abuse that could interfere with your participation in the study
\n\u2022 Have worsening muscle weakness related to current infections or medications
\n\u2022 Are pregnant, nursing, or are intending to become pregnant
\n\u2022 Are participating in any other investigational drug study<\/p>\n

Other protocol-defined inclusion\/exclusion criteria may apply<\/p>\n

Contact<\/h3>\n

Kaycie Opiyo
\n(206) 616-3132<\/p>\n

<\/p>\n

Additional Study Details<\/h3>\n

Full Study Title<\/strong>
\nA 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
\n<\/span><\/p>\n

Study ID:<\/strong> SSU00273408<\/div>\n
ClinicalTrials.gov Link:<\/strong> NCT06744920<\/a><\/div>\n
<\/div>\n
Start Date:<\/strong> 03\/06\/2025<\/div>\n
End Date:<\/strong> 04\/01\/2027<\/div>\n
<\/div>\n

Investigator(s)<\/strong>
\nB. Jane Distad, MD (Principal Investigator)
\nMichael Weiss, MD
\n<\/span>
\nAccepts Healthy Volunteers?<\/strong>
\nNo<\/span><\/p>\n

Study Site(s)<\/strong><\/p>\n

\n

University of Washington Medical Center – Montlake<\/h4>\n

1959 NE Pacific St Translational Research Unit
\nSeattle, Washington 98195<\/p>\n<\/div>\n

\n

<\/h4>\n<\/div>\n
<\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

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…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14,4,5,12],"tags":[1671,1672,1677,1675,1676,1680,1681,1668,1669,1667,1673,1674,1666,463,1651,1678,401,1679,1650,1682,1670],"class_list":["post-5919","post","type-post","status-publish","format-standard","hentry","category-allergies-immune-system","category-bone-joints-muscles","category-brain-and-nervous-system","category-eyes-and-vision","tag-acetylcholine-receptor","tag-achr","tag-autoimmune","tag-brutons-tyrosine-kinase","tag-btk-inhibitor","tag-electromyography","tag-emg","tag-generalized-mysasthenia-gravis","tag-gmg","tag-mg","tag-muscle-specific-kinase","tag-musk","tag-myasthenia-gravis","tag-neurology","tag-neuromuscular","tag-neuromuscular-junction","tag-neuroscience","tag-nmj","tag-rare-disease","tag-remibrutinib","tag-seronegative-mg"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5919","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/comments?post=5919"}],"version-history":[{"count":3,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5919\/revisions"}],"predecessor-version":[{"id":5925,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5919\/revisions\/5925"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/media?parent=5919"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/categories?post=5919"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/tags?post=5919"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}