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

Phase 2

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
• Study Start: 2025-06-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-30
• Primary Completion: 2026-11-18
• Study Completion: 2027-01-27

Recruitment & Eligibility

• Status: 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 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
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

Trial Locations

Locations (48)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0039; 🇺🇸 Columbus, Ohio, United States

Puerto Rico Multiple Sclerosis Center; 🇵🇷 Caguas, Puerto Rico

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

Neurology Center of New England; 🇺🇸 Foxboro, Massachusetts, United States

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

Hope Neurology; 🇺🇸 Knoxville, Tennessee, United States

Scroll for more (38 remaining)