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

Last updated: July 29, 2025
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Memory Loss

Neurologic Disorders

Treatment

Placebo

BMS-986368

Clinical Study ID

NCT06782490
IM045-1018
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 05, 2025
Estimated Completion Date:
January 27, 2027

Connect with a study center

  • Local Institution - 0005

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • Local Institution - 0004

    Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Local Institution - 0030

    Kent Town, South Australia 5067
    Australia

    Site Not Available

  • Local Institution - 0007

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Local Institution - 0008

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Local Institution - 0006

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Local Institution - 0019

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perron Institute

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Local Institution - 0013

    Edmonton, Alberta T6G 2G3
    Canada

    Site Not Available

  • Local Institution - 0024

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Local Institution - 0012

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0028

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Local Institution - 0014

    Lévis, Quebec G6W0M5
    Canada

    Site Not Available

  • Local Institution - 0029

    Montreal, Quebec H3A2B4
    Canada

    Site Not Available

  • Local Institution - 0055

    Brno, Brno-město 656 91
    Czechia

    Site Not Available

  • Local Institution - 0010

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Local Institution - 0054

    Prague, Praha 2 12111
    Czechia

    Site Not Available

  • Local Institution - 0059

    Prague, Praha 4 14059
    Czechia

    Site Not Available

  • Local Institution - 0011

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Local Institution - 0009

    Teplice, Ústecký Kraj 415 01
    Czechia

    Site Not Available

  • Local Institution - 0053

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Local Institution - 0052

    Wuerzburg, Bayern 97074
    Germany

    Site Not Available

  • Local Institution - 0022

    Kassel, Hessen 34121
    Germany

    Site Not Available

  • Local Institution - 0027

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • Local Institution - 0060

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Local Institution - 0031

    Meisenheim, Rheinland-Pfalz 55590
    Germany

    Site Not Available

  • Local Institution - 0023

    Jena, Thüringen 07747
    Germany

    Site Not Available

  • Local Institution - 0051

    Bielefeld, 33647
    Germany

    Site Not Available

  • Local Institution - 0021

    Dresden, 01307
    Germany

    Site Not Available

  • Local Institution - 0020

    Essen, 45122
    Germany

    Site Not Available

  • Local Institution - 0044

    Bydgoszcz, Kujawsko-pomorskie 85-796
    Poland

    Site Not Available

  • Local Institution - 0057

    Bydgoszcz, Kujawsko-pomorskie 85-163
    Poland

    Site Not Available

  • Local Institution - 0047

    Warszawa, MZ 01-684
    Poland

    Site Not Available

  • Local Institution - 0046

    Kraków, Małopolskie 30-727
    Poland

    Site Not Available

  • Local Institution - 0056

    Kraków, Małopolskie 31-503
    Poland

    Site Not Available

  • Local Institution - 0048

    Oswiecim, Małopolskie 32-600
    Poland

    Site Not Available

  • Local Institution - 0045

    Katowice, Śląskie 40-571
    Poland

    Site Not Available

  • Local Institution - 0061

    Gdańsk, 80-952
    Poland

    Site Not Available

  • Local Institution - 0051

    Slomniki, 32-090
    Poland

    Site Not Available

  • Local Institution - 0058

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Puerto Rico Multiple Sclerosis Center

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Local Institution - 0050

    Scottsdale, Arizona 85253
    United States

    Site Not Available

  • Local Institution - 0017

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Local Institution - 0015

    Tampa, Florida 33612
    United States

    Site Not Available

  • Local Institution - 0016

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Local Institution - 0049

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Neurology Center of New England

    Foxboro, Massachusetts 02035
    United States

    Active - Recruiting

  • Local Institution - 0018

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Local Institution - 0002

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Local Institution - 0039

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Local Institution - 0003

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Local Institution - 0001

    Kirkland, Washington 98034
    United States

    Site Not Available

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