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

Celgene

Status and phase: Enrolling; Phase 2

Conditions: Multiple Sclerosis Spasticity

Treatments: Drug: BMS-986368; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06782490

IM045-1018

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

Administration of BMS-986368 Dose A

Experimental group

Treatment:

Drug: BMS-986368

Administration of BMS-986368 Dose B

Experimental group

Treatment:

Drug: BMS-986368

Administration of BMS-986368 Dose C

Experimental group

Treatment:

Drug: BMS-986368

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo