Recruiting

Phase 2

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

Sponsor:

Celgene

Code:

NCT06782490

Conditions

Multiple Sclerosis Spasticity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

BMS-986368

Placebo

Study Details

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

Study ID

NCT06782490

Start date

Jun 5, 2025

Status verified date

Aug, 2026

Completion date

Jun 9, 2027

Anticipated

Primary completion date

May 26, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of BMS-986368 Dose A

experimental: Administration of BMS-986368 Dose B

experimental: Administration of BMS-986368 Dose C

placebo comparator: Placebo

Interventions

BMS-986368

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Alabama Neurology Associates

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Emily Riser, Site 0033

205-803-2210

Perseverance Research Center,LLC

Recruiting

Scottsdale, Arizona, United States, 85253

Contacts

Barry Hendin, Site 0050

602-258-3368

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

Matthew Baker, Site 0068

239-529-6780

USF Health

Recruiting

Tampa, Florida, United States, 33612

Contacts

Derrick Robertson, Site 0015

813-974-6378

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Sharon Lynch, Site 0016

913-588-6980

Neurology Center of New England

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Andrew Taylor, Site 0049

781-551-5812

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Robert Naismith, Site 0018

314-362-3293

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Shahla Hosseini, Site 0002

412-427-7087

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Jacqueline Nicholas, Site 0039

614-566-1255

Thomas Jefferson University, Jefferson Headache Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Thomas Leist, Site 0067

215-955-6871

Hope Neurology

Recruiting

Knoxville, Tennessee, United States, 37922

Contacts

Sibyl Wray, Site 0003

865-218-6222

EvergreenHealth Medical Center

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Theodore Brown, Site 0001

425-899-5385

University Of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

Gregg Blevins, Site 0013

780-248-5895

University Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Juan Racosta, Site 0024

519 685 8500x35520

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Mark Freedman, Site 0012

613-737-8104

Unity Health Toronto, St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

James Marriott, Site 0028

416-864-6060 x3450

Centre de Recherche Saint-Louis

Recruiting

Lévis, Quebec, Canada, G6W0M5

Contacts

Donald Rivest, Site 0014

418-780-3501x2703

Montreal Neurological Institute and Hospital

Recruiting

Montreal, Quebec, Canada, H3A2B4

Contacts

Adil Harroud, Site 0029

(514) 396-2950

More Information

Sponsor

Celgene

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Spasticity
Multiple Sclerosis
BMS-986368

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Celgene on 2026-08-19.