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

NCT06782490 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IM045-1018
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 53

Brief Summary

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

Conditions

Multiple Sclerosis Spasticity

Keywords

Spasticity; Multiple Sclerosis; BMS-986368

Outcome Measures

Primary Outcomes (1)

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

  At week 6

Secondary Outcomes (12)

• 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

Study Arms (4)

Administration of BMS-986368 Dose A

EXPERIMENTAL

Drug: BMS-986368

Administration of BMS-986368 Dose B

EXPERIMENTAL

Drug: BMS-986368

Administration of BMS-986368 Dose C

EXPERIMENTAL

Drug: BMS-986368

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-986368 DRUG

Specified dose on specified days

Administration of BMS-986368 Dose A; Administration of BMS-986368 Dose B; Administration of BMS-986368 Dose C

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (53)

Local Institution - 0033

Birmingham, Alabama, 35209, United States

NOT YET RECRUITING

Perseverance Research Center,LLC

Scottsdale, Arizona, 85253, United States

RECRUITING

Local Institution - 0017

Aurora, Colorado, 80045, United States

WITHDRAWN

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

USF Health

Tampa, Florida, 33612, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Local Institution - 0039

Columbus, Ohio, 43214, United States

NOT YET RECRUITING

Local Institution - 0069

Columbus, Ohio, 43235, United States

WITHDRAWN

Local Institution - 0067

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Hope Neurology

Knoxville, Tennessee, 37922, United States

RECRUITING

EvergreenHealth Medical Center

Kirkland, Washington, 98034, United States

RECRUITING

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

University of Sydney - Brain and Mind Research Institute (BMRI)

Sydney, New South Wales, 2050, Australia

RECRUITING

Centre for Neuroscience Innovation

Kent Town, South Australia, 5067, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Perron Institute

Nedlands, Western Australia, 6009, Australia

RECRUITING

University Of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

University Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Local Institution - 0028

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Centre de Recherche Saint-Louis

Lévis, Quebec, G6W0M5, Canada

RECRUITING

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A2B4, Canada

RECRUITING

Fakultni Nemocnice u sv. Anny v Brne

Brno, Brno-město, 656 91, Czechia

RECRUITING

Local Institution - 0010

Hradec Králové, Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, Praha 2, 12111, Czechia

RECRUITING

Fakultni Thomayerova nemocnice

Prague, Praha 4, 14059, Czechia

RECRUITING

Local Institution - 0011

Prague, Praha 5, 150 06, Czechia

WITHDRAWN

Nemocnice Pardubického kraje

Pardubice, 532 03, Czechia

RECRUITING

Nemocnice Teplice

Teplice, Ústecký kraj, 415 01, Czechia

RECRUITING

Klinikum Würzburg Mitte

Würzburg, Bavaria, 97074, Germany

RECRUITING

Neurologischen Gemeinschaftspraxis Kassel und Vellmar

Kassel, Hesse, 34121, Germany

RECRUITING

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Local Institution - 0060

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Local Institution - 0031

Meisenheim, Rhineland-Palatinate, 55590, Germany

WITHDRAWN

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Neurozentrum Bielefeld

Bielefeld, 33647, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Local Institution - 0020

Essen, 45122, Germany

WITHDRAWN

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

RECRUITING

Local Institution - 0044

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

NOT YET RECRUITING

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 31-503, Poland

RECRUITING

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, 01-684, Poland

RECRUITING

Local Institution - 0061

Gdansk, 80-952, Poland

WITHDRAWN

M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM

Katowice, 40-571, Poland

RECRUITING

Local Institution - 0051

Słomniki, 32-090, Poland

WITHDRAWN

Puerto Rico Multiple Sclerosis Center

Caguas, 00725, Puerto Rico

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (14); PL (9); AU (7); CA (6); DE (9); PR (1); CZ (7)