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Trial ID IM045-1018  |   NCT06782490

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

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

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18-70
    Age Range
  • 48
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have a multiple sclerosis (MS) diagnosis.
    1. Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
      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.
        1. Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
            1. 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.
              1. 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.
                1. Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
                  1. 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.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Administration of BMS-986368 Dose A

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986368

                      Study Arms

                      Experimental: Administration of BMS-986368 Dose B

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986368

                      Study Arms

                      Experimental: Administration of BMS-986368 Dose C

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986368

                      Study Arms

                      Placebo Comparator: Placebo

                      ASSIGNED INTERVENTION
                      • Drug: Placebo
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