A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

Phase 2

Not yet recruiting

• Conditions: Multiple Sclerosis Spasticity
• Interventions: Drug: BMS-986368; Drug: Placebo

• Registration Number: NCT06782490
• Lead Sponsor: Celgene

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Study Start: 2025-06-09
• Primary Completion: 2026-11-18
• Study Completion: 2027-01-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of BMS-986368 Dose C	BMS-986368	-
Placebo	Placebo	-
Administration of BMS-986368 Dose A	BMS-986368	-
Administration of BMS-986368 Dose B	BMS-986368	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score	At week 6

Secondary Outcome Measures

Name	Time	Method
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	Up to week 16
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score	At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores	At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score	At week 6
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score	At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points	Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)	Up to week 16
Serious adverse events (SAEs)	Up to week 16
Adverse events (AEs) leading to treatment discontinuation	Up to week 16
AEs leading to death	Up to week 16
AEs leading to clinically significant lab abnormalities	Up to week 16
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)	Up to week 15

Trial Locations

Locations (47)

Local Institution - 0060; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Local Institution - 0048; 🇵🇱 Oswiecim, MA, Poland

Local Institution - 0047; 🇵🇱 Warszawa, MZ, Poland

Local Institution - 0050; 🇺🇸 Scottsdale, Arizona, United States

Local Institution - 0017; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0015; 🇺🇸 Tampa, Florida, United States

Local Institution - 0016; 🇺🇸 Kansas City, Kansas, United States

Local Institution - 0049; 🇺🇸 Foxboro, Massachusetts, United States

Local Institution - 0018; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0002; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0003; 🇺🇸 Knoxville, Tennessee, United States

Local Institution - 0001; 🇺🇸 Kirkland, Washington, United States

Local Institution - 0005; 🇦🇺 Newcastle, New South Wales, Australia

Local Institution - 0004; 🇦🇺 Sydney, New South Wales, Australia

Local Institution - 0030; 🇦🇺 Kent Town, South Australia, Australia

Local Institution - 0007; 🇦🇺 Box Hill, Victoria, Australia

Local Institution - 0008; 🇦🇺 Heidelberg, Victoria, Australia

Local Institution - 0006; 🇦🇺 Parkville, Victoria, Australia

Local Institution - 0019; 🇦🇺 Nedlands, Western Australia, Australia

Local Institution - 0012; 🇨🇦 Ottawa, Ontario, Canada

Local Institution - 0013; 🇨🇦 Edmonton, Alberta, Canada

Local Institution - 0024; 🇨🇦 London, Ontario, Canada

Local Institution - 0028; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0014; 🇨🇦 Lévis, Quebec, Canada

Local Institution - 0029; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0046; 🇵🇱 Kraków, Małopolskie, Poland

Local Institution - 0055; 🇨🇿 Brno, Brno-město, Czechia

Local Institution - 0010; 🇨🇿 Hradec Kralove, Hradec Králové, Czechia

Local Institution - 0054; 🇨🇿 Prague, Praha 2, Czechia

Local Institution - 0059; 🇨🇿 Prague, Praha 4, Czechia

Local Institution - 0011; 🇨🇿 Praha, Praha 5, Czechia

Local Institution - 0053; 🇨🇿 Pardubice, Czechia

Local Institution - 0009; 🇨🇿 Teplice, Ústecký Kraj, Czechia

Local Institution - 0052; 🇩🇪 Wuerzburg, Bayern, Germany

Local Institution - 0022; 🇩🇪 Kassel, Hessen, Germany

Local Institution - 0027; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Local Institution - 0031; 🇩🇪 Meisenheim, Rheinland-Pfalz, Germany

Local Institution - 0023; 🇩🇪 Jena, Thüringen, Germany

Local Institution - 0051; 🇵🇱 Slomniki, Poland

Local Institution - 0021; 🇩🇪 Dresden, Germany

Local Institution - 0020; 🇩🇪 Essen, Germany

Local Institution - 0057; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Local Institution - 0044; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Local Institution - 0056; 🇵🇱 Kraków, Małopolskie, Poland

Local Institution - 0061; 🇵🇱 Gdańsk, Poland

Local Institution - 0045; 🇵🇱 Katowice, Śląskie, Poland

Local Institution - 0058; 🇵🇷 Caguas, Puerto Rico