Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cladribine Low Dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 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: If clinically justified, participants requiring retreatment with cladribine Low Dose or High Dose or cladribine supplemental dose will receive the selected dose of cladribine or matching placebo regimen. |
| Cladribine Low Dose | EXPERIMENTAL | 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: If clinically justified, participants requiring retreatment with cladribine Low Dose regimen and/or supplemental dose will receive the selected dose of cladribine or matching placebo regimen. |
| Cladribine High Dose | EXPERIMENTAL | 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: If clinically justified, participants requiring retreatment with cladribine High Dose regimen and/or supplemental dose will receive the selected dose of cladribine or matching placebo regimen. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Adults of ≥ 18 years of age at the time of signing the informed consent. * 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 A...
Cladribine Low Dose is an investigational small molecule being studied for the treatment of generalized myasthenia gravis, a chronic autoimmune neuromuscular disease. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Cladribine Low Dose is a small molecule that works by targeting and depleting certain immune cells, specifically lymphocytes, which play a role in the autoimmune attack on neuromuscular junctions in generalized myasthenia gravis. This mechanism aims to reduce the abnormal immune response.
Cladribine Low Dose is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in generalized myasthenia gravis.
Cladribine Low Dose is in Phase 3 clinical development for generalized myasthenia gravis. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is actively recruiting participants.
Cladribine Low Dose is being evaluated in a Phase 3 clinical trial with the identifier NCT06463587, titled 'Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad).' This randomized, double-blind, placebo-controlled study plans to enroll 264 participants across multiple countries.
Cladribine Low Dose is a specific low-dose formulation of cladribine, a purine nucleoside analog. While the active ingredient is the same, this new formulation is being developed specifically for generalized myasthenia gravis and is currently in Phase 3 trials, distinct from other cladribine products approved for different indications.