← Back to Search

Anti-metabolites

Cladribine for Myasthenia Gravis

Phase 3
Recruiting
Research Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization
Has a history of or current diagnosis of active tuberculosis (TB)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to test a new oral medication for Generalized Myasthenia Gravis (gMG) compared to a placebo. It will look at how effective and safe the medication is over time

Who is the study for?
This trial is for individuals with Generalized Myasthenia Gravis, a condition causing muscle weakness. Participants should not have taken certain other medications recently and must meet specific health criteria to ensure safety during the trial.
What is being tested?
The study tests a new oral formulation of Cladribine at two different doses against a placebo to evaluate its effectiveness and safety in treating gMG. The trial includes initial treatment, follow-up extensions, and possible retreatment phases.
What are the potential side effects?
While the side effects of this new Cladribine formulation are being studied, common ones may include low white blood cell count, infections, nausea, and potential liver issues as seen with similar drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Myasthenia Gravis with moderate to severe muscle weakness.
Select...
I tested positive for anti-AChR or anti-MuSK antibodies.
Select...
I am 18 years old or older.
Select...
I weigh at least 40 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any nonsteroidal immunosuppressants for my gMG in the last 4 weeks.
Select...
I have been diagnosed with or have a history of active tuberculosis.
Select...
I have cancer or have had cancer in the past.
Select...
I had my thymus gland removed within the last 6 months.
Select...
I haven't taken eculizumab, rozanolixizumab, efgartigimod, ravulizumab, or zilucoplan in the last 8 weeks.
Select...
I do not have antibodies for chickenpox.
Select...
I have had seizures, but not just fever-related ones as a baby.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cladribine Low DoseExperimental Treatment1 Intervention
DBPC Period: Participants will be administered with cladribine Low Dose, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5. BE Period: Participants initially randomized to cladribine Low Dose in DBPC period will receive placebo matched to cladribine as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated with cladribine supplemental dose if clinically justified. RT Period: Participants requiring retreatment with cladribine Low Dose regimen and/or supplemental dose will receive the selected dose of cladribine if clinically justified.
Group II: Cladribine High DoseExperimental Treatment1 Intervention
DBPC Period: Participants will be administered cladribine High Dose, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5. BE Period: Participants initially randomized to cladribine High Dose in DBPC period will receive placebo matched to cladribine as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated with cladribine supplemental dose if clinically justified. RT Period: Participants requiring retreatment with cladribine High Dose regimen and/or supplemental dose will receive the selected dose of cladribine if clinically justified.
Group III: PlaceboPlacebo Group3 Interventions
DBPC Period: Participants will be administered with Placebo, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5. BE Period: Participants initially randomized to placebo matched to cladribine in DBPC period will receive cladribine Low Dose or High Dose, orally as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated if clinically justified with placebo matched to cladribine. RT Period: Participants requiring retreatment with cladribine Low Dose or High Dose or retreated with cladribine supplemental dose if clinically justified.

Find a Location

Who is running the clinical trial?

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor
54 Previous Clinical Trials
7,112 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Industry Sponsor
82 Previous Clinical Trials
22,386 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
295 Previous Clinical Trials
60,740 Total Patients Enrolled
~160 spots leftby May 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top