A Phase 2 interventional study of BMS-986368 and Placebo in Multiple Sclerosis Spasticity, sponsored by Celgene. Recruiting at 61 sites in 7 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.
This study's planned enrollment of 200 is above the median of 36 across 472 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted after Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986368
Drug: BMS-986368
Drug: BMS-986368
Drug: Placebo
Specified dose on specified days
Specified dose on specified days
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Time frame: At week 6
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Time frame: At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Time frame: At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Time frame: At week 6
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
Time frame: At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Time frame: Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 16
Serious adverse events (SAEs)
Time frame: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Time frame: Up to week 16
AEs leading to death
Time frame: Up to week 16
AEs leading to clinically significant lab abnormalities
Time frame: Up to week 16
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 16
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to week 15
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Irafamdastat