Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celgene Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Nervous System Diseases [C10]

Trial duration

24 Sep 2025 → ongoing

Decision date (initial)

2025-09-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Celgene Corporation

External identifiers

EU CT number

2024-517745-14-00

WHO UTN

U1111-1312-8812

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy

The main goal (objective) of the study is to understand the effect of BMS-986368 compared with placebo (a pill with no medicine), on spasticity in patients with MS.

Secondary objectives 2

1. Other important (secondary) goals of the study are to understand the effect of BMS- 986368 compared with placebo on walking, overall ability to function, and patients’ experience living with spasticity in patients with MS
2. Other secondary goals are to learn more about how safe BMS-986368 is and to understand the levels of drug in the body after taking BMS-986368 in patients with MSS (Multiple Sclerosis Spasticity).

Conditions and MedDRA coding

Multiple Sclerosis Spasticity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants must be 18-70 years old who have a multiple sclerosis (MS) diagnosis.
2. Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1 (Screening).
3. 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.
4. Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 (meaning moderate-significant disability) at Visit 1.

Exclusion criteria 4

1. Participants must not have had any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant’s level of spasticity.
2. 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 (Randomization).
3. Participants must not have a history of any substance abuse disorder. Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
4. Participants must not have used cannabinoid-related products (including cannabis, CBD, or THC) within 30 days prior to Visit 1. Other protocol defined Inclusion/Exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this

Secondary endpoints 2

1. The secondary trial endpoints include the Numeric Rating Scale-Spasticity (NRS-S), which is a question answered every day using an eDiary provided to the participant.
2. Other secondary endpoints include the MS Spasticity Scale (MSSS-88), a set of questions asking about spasticity in the participant’s daily life, the Timed 25-Foot Walk (T25FW) test, a test to see how long it takes the participant to walk 25 feet, and the Clinical Global Impression of Severity, a question for the investigator to determine how severe the participant’s condition is.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene Corp.

Sponsor organisation

Celgene Corp.

Address

Route 206 And Province Line Road

City

Princeton

Postcode

08543-4000

Country

United States

Scientific contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Public contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Third parties 4

Locations

3 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications