Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

NCT ID: NCT01433497

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2020-02-29

Brief Summary

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).

Conditions

Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Arm A

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.

Group Type: EXPERIMENTAL

Masitinib

Intervention Type: DRUG

Experimental Arm B

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.

Group Type: EXPERIMENTAL

Masitinib

Intervention Type: DRUG

Placebo Comparator A

Participants receive placebo given orally twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Comparator B

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Masitinib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

AB1010; Placebo Oral Tablet

Eligibility Criteria

Inclusion Criteria

• Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald's criteria.

Exclusion Criteria

• Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AB Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Vermersch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Salengro, Lille, France

Locations

"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment

Sofia, , Bulgaria

GHICL hopital ST vincent de Paul

Lille, , France

Hôpital de Gui de Chauliac

Montpellier, , France

Universitätsklinikum Gießen und Marburg

Marburg, , Germany

Rehibilitation Center "KENTAVROS"

Volos, , Greece

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Centrul Medical Clubul Sănătăţii

Campulung Muscel, , Romania

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Bulgaria; France; Germany; Greece; Poland; Romania; Spain

References

Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

Reference Type: DERIVED

PMID: 35190477 (View on PubMed)

Other Identifiers

AB07002

Identifier Type: -

Identifier Source: org_study_id