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CTRI Number  CTRI/2025/07/092102 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to examine usefulness and safety of remibrutinib in patients with generalized myasthenia gravis.  
Scientific Title of Study   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 
Trial Acronym  RELIEVE 
Secondary IDs if Any  
Secondary ID  Identifier 
CLOU064O12301_Protocol v01 dated 11-Jun-2024   Protocol Number 
NCT06744920  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Rashmi Chitgupi 
Designation  Country Head - Clinical Management 
Affiliation  PPD, part of Thermo Fisher Scientific  
Address  PPD, part of Thermo Fisher Scientific, 102, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai Mumbai

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax    
Email  rashmi.chitgupi@thermofisher.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi 
Designation  Country Head - Clinical Management 
Affiliation  PPD, part of Thermo Fisher Scientific  
Address  PPD, part of Thermo Fisher Scientific, 102, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai Mumbai

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax    
Email  rashmi.chitgupi@thermofisher.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG Novartis Pharma AG Lichtstrasse 35, 4056 Basel town, Switzerland  
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai - 400051,lndia 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Belgium
Brazil
Canada
China
France
Georgia
Germany
India
Italy
Japan
Netherlands
Poland
Romania
Serbia
Spain
Taiwan
United Kingdom
United States of America
Republic of Korea  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Achal Srivasrtava  All India Institute of Medical Sciences  Ansari Nagar, AIIMS Campus, New Delhi- 110029 India
New Delhi
DELHI 		 9811178784

achalsrivastava@hotmail.com 
Dr Amit Yeole  Chopda Medicare & Research Centre Pvt. Ltd.  Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India
Nashik
MAHARASHTRA 		 7588554530

amit_yeole37@rediffmail.com 
Dr Ajith Sivadasan  Christian Medical College  Ranipet Campus, Kilminnal Village, Vellore- 632517 Tamil Nadu, India
Vellore
TAMIL NADU 		 9894197059

ajiths@cmcvellore.ac.in 
Dr Monika Singla  Dayanand Medical College and Hospital  Civil Lines, Tagore Nagar, Ludhiana- 141001 Punjab, India
Ludhiana
PUNJAB 		 9872662436

drmonika78@yahoo.com 
Dr Shankara Nellikunja  Mallikatta Neuro Centre  Opposite Mallikatta Circle, Kadri, Mangalore-575002, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9845080925

dr.shankaramnc@gmail.com 
Dr Praveen Gupta  Marengo Asia Hospitals, Gurugram (part of NORTH EAST HEALTH CARE PVT LTD)  Golf Course Ext Rd, Sushant Lok II, Sector 56, Gurugram, Ghata, Haryana, India, 122011
Gurgaon
HARYANA 		 9891907903

praveenguptapg@gmail.com 
Dr Surya Prabha Turaga  Nizams Institute of Medical Sciences  Clinical Research Room, Ground Floor, Millennium Building, Punjagutta Road, Punjagutta Market, Punjagutta, Hyderabad, Telangana- 500082, India
Hyderabad
TELANGANA 		 9246589899

surmukh99@gmail.com 
Dr Usha Kant Misra  Vivekanand Polyclinic and Institute of Medical Sciences  Vivekanand Puram Lucknow 226007
Lucknow
UTTAR PRADESH 		 9450653685

drukmisra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Drug Trial Ethics Committee  Approved 
EC of North East Healthcare Pvt Ltd  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee Vivekanand Polyclinic and Institute of Medical Sciences  Approved 
Institutional Review Board Christian Medical College  Approved 
Magna-Care Ethics Committee  Approved 
Mangala Institutional Ethics Committee  Approved 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G700||Myasthenia gravis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   Dummy drug given in same manner as Intervention. Placebo arm: placebo orally b.i.d. for 6 months (double-blind)  
Intervention  Remibrutinib   Remibrutinib (LOU064) Remibrutinib arm: remibrutinib orally at 100 mg b.i.d. for 6 months (double-blind) followed by open-label remibrutinib at 100 mg b.i.d. for an additional 60 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with generalized Myasthenia Gravis who are not intubated (MGFA Class two to four)
2. Baseline MG ADL score of at least 6, with at least 50 percentage of the total score due to non ocular symptoms
3. Participants who are receiving at least one of the following treatments for generalized Myasthenia Gravis
just one NSIST for at least 6 months or
acetylcholinesterase inhibitors for at least 1 month on a maximum stable dose or
steroids for at least 4 months including the inability to taper to an acceptable level
Note, Non steroidal immunosuppressive therapies (NSIST) include azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, or tacrolimus
4. Participants who are receiving
azathioprine, are required to be on a stable dose for at least 2 months prior to baseline
Other immunosuppressive therapies are required to be on a stable dose for at least 1 month prior to baseline
Oral corticosteroids are required to be on a stable dose for at least 4 weeks prior to baseline
Cholinesterase inhibitors are required be on a stable dose for at least 2 weeks prior to baseline
5. Able to safely swallow study medication



 
 
ExclusionCriteria 
Details  1. Prior to baseline have been treated with Intravenous Immunoglobulin or plasmapheresis in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti neonatal Fc receptor therapies in the past 3 months or had a thymectomy in the past 6 months or a planned thymectomy during the trial period.
2. Participants with a known immunodeficiency syndrome
3. Pregnant or nursing (breast feeding) women
4. Women of child bearing potential unless they are using highly effective methods of contraception while taking study treatment and for 1 week after stopping study treatment.
5. Active systemic bacterial, viral including coronavirus disease 19, parasitic, or fungal infection or any major episode of infection that required hospitalization or injectable antimicrobial therapy within 14 days prior to study drug administration
6. Have received any live or live attenuated vaccines within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study.
7. History of hepatic disease that currently requires treatment or ongoing hepatic disease.
8. Major surgery within 8 weeks prior to screening
9. History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, at screening
10. History of autoimmune diseases other than MG (example, thyroiditis, rheumatoid arthritis, et cetera)
11. Requirement for anticoagulant medication (example warfarin or non vitamin K antagonist oral anticoagulants) or use of dual antiplatelet therapy (example, acetylsalicylic acid plus clopidogrel). The use of acetylsalicylic acid up to 100 milligram per day or clopidogrel up to 75 milligram per day is permitted
12. History or current diagnosis of clinically significant cardiac arrhythmias
13. Patient requiring frequent (quarterly or more frequent) plasmapheresis or intravenous immunoglobulin to control symptoms
14. History of galactose intolerance, total lactase deficiency and glucose galactose malabsorption
15. Ongoing drug or alcohol abuse
16. Participants who have had a splenectomy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to Month 6 in Myasthenia
Gravis Activity of Daily Living (MG-ADL) total
Score 		 Baseline, Month 0.5, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 
 
Secondary Outcome  
Outcome  TimePoints 
-Change from baseline to Month 6 in Quantitative MG (QMG) total score
Change from baseline to Month 6 in MGC total score
-Change from baseline to Month 6 in revised MGQuality of Life Questionnaire MG-QOL15r survey score
-Proportion of participants achieving MSE at Month 6, defined as MG-ADL score of 0 or 1 at Month 6 without rescue therapy and/or strongly confounding prohibited medication
-Proportion of participants with greater than or equal to 5 points reduction from baseline to Month 6 of QMG total score without rescue medication and/or strongly confounding prohibited medication
-Proportion of participants with greater than or equal to 3 points reduction from baseline to Month 6 of MG-ADL total score without rescue medication and/or strongly confounding prohibited medication
 		 Baseline, Month 0.5, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The purpose of this study is to evaluate the efficacy, safety and tolerability of remibrutinib in patients with generalized Myasthenia Gravis (gMG) who are acetylcholine receptor positive (AChR+), muscle-specific tyrosine kinase positive (MuSK+), or double seronegative (AChR- and MuSK-) who are on stable, standard-of-care (SOC) treatment. The study aims to evaluate whether treatment with remibrutinib will result in the reduction of the total score in Myasthenia Gravis Activity of Daily Living (MG-ADL) scale as compared to placebo.  
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