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

• BMS-986368 (Drug): Specified dose on specified days
• Placebo (Drug): Specified dose on specified days

Primary outcomes

• Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score [At week 6]

Secondary outcomes

• 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 suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [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]

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria

* Participants must have a multiple sclerosis (MS) diagnosis.
* Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
* Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.
* Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.

Exclusion Criteria

* Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
* Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.
* Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse.
* Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
* Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb