| CTRI Number |
CTRI/2025/04/085012 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis |
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Scientific Title of Study
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis |
| Trial Acronym |
MyClad |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MS700568_0183 V2.0 dated 14 March 2024 |
Protocol Number |
| MS700568_0183 V4.0 dated 11 Jun 2025 |
Protocol Number |
| NCT06463587 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Shweta Pradhan |
| Designation |
Head R&D Operations, India Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli
Bangalore
KARNATAKA
560103
India |
| Phone |
919833992566 |
| Fax |
|
| Email |
shweta.pradhan@iqvia.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Pradhan |
| Designation |
Head R&D Operations, India Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli
Bangalore
KARNATAKA
560103
India |
| Phone |
919833992566 |
| Fax |
|
| Email |
shweta.pradhan@iqvia.com |
|
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Source of Monetary or Material Support
|
| Merck Healthcare KGaA,
Frankfurter Strasse 250,
Darmstadt,64293, Germany |
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Primary Sponsor
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| Name |
Merck Healthcare KGaA |
| Address |
Frankfurter Strasse 250
64293 Darmstadt, Germany |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDSIndia Pvt Ltd |
Omega Embassy TechSquare,
Marathahalli-Sarjapur Outer Ring Road,
Kadubeesanahalli,
Bangalore – 560103,
Karnataka |
|
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Countries of Recruitment
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Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
France
Georgia
Germany
Greece
Hungary
India
Italy
Japan
Mexico
Poland
Republic of Korea
Romania
Serbia
South Africa
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
United States of America |
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Sites of Study
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| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveen Kumar S |
Bangalore Medical College and Research Institute |
K R Road, Fort, 560002
Bangalore
KARNATAKA |
9113030135
dmpraveens@gmail.com |
| Dr Amit Bhalchandra Yeole |
Chopda Medicare & Research Centre Pvt Ltd; Magnum Heart Institute |
Department of Neurology, OPD, Ground Floor, 3/5 Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, 422005
Nashik
MAHARASHTRA |
7588554530
0253-2313613
amit_yeole37@rediffmail.com |
| Dr Amit Ranjan Barua |
GNRC Medical |
GNRC Institute of Medical Science- A unit of GNRC Ltd., Near IIT, Sila Grant, North Guwahati-781031
Kamrup
ASSAM |
9864084855
amitrbarua@gmail.com |
| Dr Sanjay Ganpat Ramteke |
Jasleen Hospital |
Jasleen Building, Godhni, Panchsheel Square, 440012
Nagpur
MAHARASHTRA |
9890332286
ssrt95@yahoo.co.in |
| Dr Rahul Vitthal Kulkarni |
Lata Mangeshkar Medical Foundation’s Deenanath Mangeshkar Hospital & Research Center |
Super Speciality Building, 2nd Floor, Neurology Department, Room No.17 and Room No.3, Off Karve Road, Erandawane, 411004
Pune
MAHARASHTRA |
9822012588
rahulneuro@gmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Centre |
3rd Floor (Clinical Research Department), Opp. Mallikatta Circle, Kadri, Mangalore - 575002
Dakshina Kannada
KARNATAKA |
9845080925
dr.shankaramnc@gmail.com |
| Dr Sireesha Yareeda |
Nizams Institute of Medical Sciences |
Millennium Block, Ground floor,
Movement Disorder Clinic,
Department of Neurology
Panjagutta, 500082
Hyderabad
TELANGANA |
9966406827
mailforsiree@gmail.com |
| Dr Jaydip Ray Chaudhuri |
Yashoda Hospitals |
Raj Bhavan Road, Somajiguda, 500082
Hyderabad
TELANGANA |
9849007975
jaydiprc@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Aureus Institute of Medical Sciences Ethics Committee |
Approved |
| Ethics Committee Institute of Neurological Science |
Submittted/Under Review |
| Ethics Committee of BMCRI, Bangalore Medical College and Research Institute |
Approved |
| Institutional Ethics committee Deenanath Mangeshkar Hospital And Research Centre |
Submittted/Under Review |
| Magnacare Ethics Committee |
Approved |
| Mangala Institutional Ethics Committee |
Approved |
| NIMS Institutional Ethics Committee |
Approved |
| Yashoda Academy of Medical Education and Research |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G700||Myasthenia gravis, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cladribine High Dose 105mg |
Participants will receive cladribine high dose of 105mg in two courses separated by 4 weeks. |
| Intervention |
Cladribine Low Dose 52.5mg |
Participants will receive cladribine low dose of 52.5mg in two courses separated by 4 weeks |
| Comparator Agent |
Placebo |
Participants will receive placebo matched to cladribine in two courses separated by 4 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of more than or equal to 18 years of age at the time of signing the informed consent.
2. Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for MGFA Class II to IVa classification.
a. In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody(anti-MuSK).
b. In participants that are autoantibody seronegative and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4).
3. Has a Screening and Baseline MG ADL score more than or equal to 6 with at least 50 percent of the total score due to non ocular symptoms. Screening and Baseline MG-ADL scores must be stable. The difference between the Screening and Baseline scores should not be more than 2 and there should be no reported MG exacerbation during the Screening period.
4. If treated with oral corticosteroids: should be on a stable daily dose for at least 3 months prior to and during screening. In such case, the daily dose of oral steroids should not exceed 20 mg per day for prednisone or prednisolone or 16 mg per day for methylprednisolone.
5. If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose less than or equal to 480 mg per day) for at least 3 months prior to and during screening.
6. Have a body weight more than or equal to 40 kg.
7. Other protocol defined inclusion criteria could apply.
|
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| ExclusionCriteria |
| Details |
1. Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating Investigator or the participants regular treating physician recorded in the source documents, is not exclusionary
2. Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness
3. Active, clinically significant viral, bacterial, or fungal infection, including brain MRI findings consistent with signs of infection such as PML, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 8 weeks prior or during Screening, or completion of oral anti-infectives within 8 weeks prior or during Screening. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary
4. Has a history of or current diagnosis of active tuberculosis (TB)
5. Active malignancy, or history of cancer
6. Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization
7. Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization
8. History of thymectomy within 6 months prior to Screening.
9. History of generalized seizures (except for history of infantile febrile seizures)
10. Negative for Varicella Zoster Virus antibodies at screening
History of myasthenic crisis in the last 12 months prior to and during screening
11. History of recurrent infections (that is 3 or more infections per year) within the last 2 years
12. Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within the last 6 months prior to Screening
13. If treated with non-steroidal immunosuppressants for gMG, the dose at Screening should not exceed 50 mg/day for azathioprine, 500 mg/day for mycophenolate mofetil, 1 mg/day for tacrolimus, 50 mg/day for cyclosporine, or 7.5 mg/week for methotrexate
14. Participation in clinical study of any investigational drug within 6 months, or 5 half-lives of the investigational drug used in the previous clinical study prior to randomization, whichever is longer. However, participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure
15. Other protocol defined exclusion criteria could apply |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period |
Baseline, Week 24 |
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Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period
|
Baseline, Week 24
|
| Percentage of MG-ADL Responders at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period |
At Week 24 |
| Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period |
Baseline, Week 24 |
| Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period |
At Week 24 |
| Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study |
Up to End of Study (Week 144) |
| Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) |
Up to End of Study (Week 144) |
| Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 |
Up to End of Study (Week 144) |
| Number of Participants with Abnormal Laboratory Variables including Absolute Lymphocyte Count and Vital Signs |
Up to End of Study (Week 144) |
| Pharmacokinetic (PK) Plasma Concentration of Cladribine |
Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose |
| Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period |
Baseline, Week 24 |
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Target Sample Size
Modification(s)
|
Total Sample Size="264"
Sample Size from India="11"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
13/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="9"
Days="3" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The purpose of this clinical
study is to determine the efficacy and safety of a new oral cladribine
formulation in participants with Generalized Myasthenia Gravis (gMG) in
comparison to placebo. It will also investigate the sustained efficacy, the
need for retreatment, and the long-term safety of oral cladribine in gMG. An
additional component is included to characterize the Pharmacokinetics (PK) of
the new cladribine formulation in gMG participants. This study is divided into
3 periods: the double-blind placebo control (DBPC) pivotal period, and 2
extensions, the blinded extension (BE) and the retreatment (RT) period. |