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Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis (MyClad)
EU CTIS ID: 2023-507746-83-00
What this study is testing
To assess the clinical efficacy of cladribine capsules (high and low doses) on gMG relative to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- "Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification. - In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody (anti-MuSK) - In participants that are autoantibody seronegative and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4) "
- 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.
- 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 milligrams(mg)/day for prednisone/prednisolone or 16 mg/day for methylprednisolone.
- If treated with acetylcholinesterase inhibitor should be on a stable daily dose for at least 3 months prior and during screening..
- Have a body weight >= 40 kilograms.
- Other protocol defined inclusion criteria could apply.
You likely can't join if
- 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.
- Active malignancy, or history of cancer.
- Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization.
- History of generalized seizures (except for history of febrile seizures during the participant’s childhood)
- History of recurrent infections (that is 3 or more infections per year) within the last 2 years
- 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
See the full eligibility criteria
Who can join
- "Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification. - In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody (anti-MuSK) - In participants that are autoantibody seronegative and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4) "
- 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.
- 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 milligrams(mg)/day for prednisone/prednisolone or 16 mg/day for methylprednisolone.
- If treated with acetylcholinesterase inhibitor should be on a stable daily dose for at least 3 months prior and during screening..
- Have a body weight >= 40 kilograms.
- Other protocol defined inclusion criteria could apply.
What rules you out
- 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.
- Active malignancy, or history of cancer.
- Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization.
- History of generalized seizures (except for history of febrile seizures during the participant’s childhood)
- History of recurrent infections (that is 3 or more infections per year) within the last 2 years
- 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
- 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
- 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
- Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization
- History of thymectomy within 6 months prior to Screening.
- History of myasthenic crisis in the last 12 months prior to and during screening
- Applicable for France only: Persons under court protection, persons not affiliated to a social security system, protected adults.
- Negative for Varicella Zoster Virus antibodies at screening.
- Other protocol defined exclusion criteria could apply.
- 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.
- 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, or a history of recurrent infections. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.
- Has a history of or current diagnosis of active tuberculosis (TB).
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Japan
- Serbia
- Georgia
- Canada
- China
- Turkey
- Switzerland
- India
- Argentina
- United States
- Australia
- Brazil
- Taiwan
- United Kingdom
- Mexico
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Japan; Serbia; Georgia; Canada; China and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.