Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

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

Sponsors

Lead Sponsor: AB Science

Source AB Science
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.

Overall Status Recruiting
Start Date 2022-06-28
Completion Date 2025-12-01
Primary Completion Date 2025-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to confirmed progression 96 weeks
Secondary Outcome
Measure Time Frame
Time to Expanded Disability Status Scale (EDSS) score of 7.0 96 weeks
Overall Change in Expanded Disability Status Scale (EDSS) Score 96 weeks
Brain Magnetic Resonance Imaging Assessments 96 weeks
Multiple Sclerosis Quality of Life (MSQOL)-54 96 weeks
Enrollment 800
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: treatment per os

Arm Group Label: Placebo

Other Name: Placebo Oral Tablet

Intervention Type: Drug

Intervention Name: Masitinib (4.5)

Description: Masitinib (titration to 4.5 mg/kg/day)

Arm Group Label: Masitinib (4.5)

Other Name: AB1010

Eligibility

Criteria:

Main inclusion criteria include: - Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening - Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline - Patients with an EDSS score progression ≥1 point with no improvement during 2 years - Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening Main exclusion criteria include: - Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening - Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic - Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline - Patients with lymphocytes <1.0 × 10^9/L at screening and at baseline

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Patrick VERMERSCH, MD, PhD Principal Investigator University of Lille, CHU of Lille, France
Overall Contact

Last Name: Clinical Study Coordinator

Phone: +33(0)147200014

Email: [email protected]

Location
Facility: Status:
Hôpital Roger Salengro | Lille, France Not yet recruiting
Centre Hospitalier Universitaire de Strasbourg | Strasbourg, France Recruiting
Location Countries

France

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Masitinib (4.5)

Type: Experimental

Description: Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control.

Label: Placebo

Type: Placebo Comparator

Description: Participants receive a matched dose placebo, given orally twice daily.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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