Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis (MAXIMS)
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis (MAXIMS)
ClinicalTrials.gov ID: NCT05441488
Sponsor: AB Science
Information provided by: AB Science (Responsible Party)
Last Update Posted: 2023-03-30
Brief Summary:
To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
Detailed Description:
Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). This is a multicenter, double-blind, randomized, placebo-controlled, comparative study of oral masitinib in the treatment of patients with progressive MS who were progressing but not clinically active.
OFFICIAL TITLE
A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse
INTERVENTION / TREATMENT
Drug: Placebo
Drug: Masitinib (4.5)
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-06-28 |
| Primary Completion (Estimated) | 2025-12 |
| Study Completion (Estimated) | 2025-12 |
| Enrollment (Estimated) | 800 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | AB20009; MAXIMS |