At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Placebo (other), Cladribine Low Dose (drug), Cladribine High Dose (drug)
- How long the study runs
- Study runs about 77 months (dates as stated)
- About the drug or intervention
- Placebo — other: Participants will receive placebo matched to cladribine in two courses separated by 4 weeks. · Cladribine Low Dose — drug: Participants will receive cladribine low dose in two courses separated by 4 weeks. · Cladribine High Dose — drug: Participants will receive cladribine high dose in two courses separated by 4 weeks.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 264
- Started
- 2024-06-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for generalized myasthenia gravis
- • Phase3 - 264 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with generalized myasthenia gravis
Where?
- • London - Queen Square Centre for Neuromuscular Diseases
- • Nottingham - Nottingham University Hospitals NHS Trust
- • Sheffield - Royal Hallamshire Hospital - Dept of Neurology
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults of ≥ 18 years of age at the time of signing the agreement to take part.
- ✓Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis...
- ✓In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody(anti-MuSK)
- ✓If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose ≤ 480 mg/day or...
- ✓Have a body weight \>= 40 kilograms
Who cannot take part
- ✗Active cancer, or history of cancer or signs of cancer in any Screening assessment
- ✗Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil,...
- ✗Treatment with FcRn or complement inhibitors (such as eculizumab, rozanolixizumab efgartigimod, ravulizumab,...
- ✗History of thymectomy within 6 months prior to Screening.
- ✗History of generalized seizures (except for history of febrile seizures during the participant's childhood).
See the full criteria
Where Is This Study? (3 UK sites)
Queen Square Centre for Neuromuscular Diseases
London SE1 9RT, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham NG7 2UH, United Kingdom
Royal Hallamshire Hospital - Dept of Neurology
Sheffield S10 2JF, United Kingdom
How to Get in Touch
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