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  • NCT06782490

Recruiting

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity - IM045-1018

Updated: 11 November, 2025   |   ClinicalTrials.gov

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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CONSIDERING THIS TRIAL?
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SELECT LANGUAGE

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-70

    Age Range

  • 49

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of BMS-986368 Dose A
Drug: BMS-986368
Experimental: Administration of BMS-986368 Dose B
Drug: BMS-986368
Experimental: Administration of BMS-986368 Dose C
Drug: BMS-986368
Placebo Comparator: Placebo
Drug: Placebo

Key Eligibility Criteria

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.

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MLTNO2000046