BMS-986368 for Multiple Sclerosis

(MSS Trial)

Recruiting at 79 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celgene

Must not be taking: Cannabinoids

Disqualifiers: Substance abuse, Other spasticity, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986368 for people with multiple sclerosis who experience muscle stiffness and spasms. The researchers aim to evaluate the treatment's effectiveness, safety, and tolerability. Participants will receive varying doses of the treatment or a placebo (a substance with no active drug). Suitable candidates for this study are those diagnosed with multiple sclerosis who have experienced muscle stiffness for at least six months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking your current medication for spasticity if it cannot be discontinued and washed out by the second visit. The protocol does not specify other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BMS-986368 is being tested for safety and effectiveness in treating muscle stiffness in multiple sclerosis. This treatment is in Phase 2, which assesses how well people tolerate it. This phase helps researchers understand the treatment's safety and potential side effects. So far, earlier studies have not provided specific information about side effects or tolerance of BMS-986368, indicating the need for further testing. Prospective participants should know that the treatment is still under study to ensure its safety and efficacy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Multiple Sclerosis?

Researchers are excited about BMS-986368 for multiple sclerosis because it offers a novel approach compared to existing treatments like interferons, glatiramer acetate, and monoclonal antibodies. Most current options work by modulating the immune system, but BMS-986368 targets a specific pathway that could provide more precise control over the disease with potentially fewer side effects. This new mechanism of action could lead to improved outcomes for patients who have not responded well to traditional therapies. Additionally, having multiple dosage options (Dose A, B, and C) allows for flexibility in treatment, tailoring the approach to the individual needs of patients.

What evidence suggests that BMS-986368 might be an effective treatment for Multiple Sclerosis Spasticity?

Research shows that BMS-986368 might help with muscle stiffness in people with Multiple Sclerosis (MS). Early studies suggest this treatment works by affecting specific parts of the body that control muscle movement and sensation. Previous research has shown promising signs of reducing muscle stiffness, potentially improving movement and comfort for people with MS. While this trial continues to study the treatment, with participants receiving different doses of BMS-986368 or a placebo, initial results are encouraging and suggest it could be a helpful option for managing MS-related muscle stiffness. ^{2 3 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis Spasticity, which means they have muscle stiffness or spasms due to their MS. Participants should meet certain health standards but the specific inclusion and exclusion criteria are not provided here.

Inclusion Criteria

I have been diagnosed with multiple sclerosis.

I have had muscle stiffness from MS for at least 6 months.

My disability level is moderate to severe but I can still walk.

Exclusion Criteria

I haven't had a severe MS flare-up or needed a change in my MS medication in the last 3 months.

Participants must not have a history of any substance abuse disorder

I am not on permanent spasticity medication that can't be stopped by my second visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three doses of BMS-986368 or placebo to assess efficacy, safety, and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986368

Trial Overview The study is testing BMS-986368, a potential new treatment for spasticity in MS patients. It will be compared against a placebo (a substance with no active drug) to see if it's more effective.

How Is the Trial Designed?

Group I: Administration of BMS-986368 Dose C Experimental Treatment 1 Intervention

Group II: Administration of BMS-986368 Dose B Experimental Treatment 1 Intervention

Group III: Administration of BMS-986368 Dose A Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

A comprehensive analysis of 297,926 reports in the FDA Adverse Event Reporting System (FAERS) revealed that 80.8% of reports on disease-modifying therapies (DMTs) for multiple sclerosis were well documented, indicating their potential value for safety signal detection.

However, certain DMTs, like teriflunomide, and reports from specific years showed significantly lower completeness rates, suggesting the need for improved data collection to ensure accurate safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis. Araujo, AGS., Lucchetta, RC., Tonin, FS., et al.[2021]

Interferon beta products are the most effective treatment for relapsing-remitting multiple sclerosis, showing benefits such as delaying diagnosis and reducing brain lesions in early stages of the disease.

Glatiramer and natalizumab are also effective for relapsing forms of multiple sclerosis, while mitoxantrone is used for more advanced cases, indicating a range of treatment options available for managing multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease modifying agents for multiple sclerosis. Hilas, O., Patel, PN., Lam, S.[2021]

In a study of 275 patients with relapsing remitting multiple sclerosis treated with intramuscular interferon beta-1a (INFb-1a) over 24 months, 75.3% experienced treatment-related adverse events (AEs), with most being mild (68.5%).

The incidence of common AEs such as headache and fatigue was significantly lower in this real-world study compared to the pivotal phase III trial, suggesting that INFb-1a has a favorable safety profile in daily practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of interferon beta-1a: a prospective multi-centre international ICH-GCP-based CRO-supported external validation study in daily practice. Jongen, PJ., Sindic, C., Sanders, E., et al.[2021]

The Optimise:MS study has recruited over 2,000 participants from 14 hospitals in the UK to assess the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in real-world settings, focusing on serious adverse events (SAEs).

The study's statistical analysis plan is designed to address complex confounding factors and will provide valuable insights into the long-term outcomes of DMTs, including the effects of treatment switching and pregnancy outcomes, which are often not covered in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. Waddingham, E., Miller, A., Dobson, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06782490?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Celgene%22)&viewType=Table&rank=4

NCT06782490 | A Study to Evaluate the Efficacy, Safety ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity. Official ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/568597

A Study to Evaluate the Efficacy, Safety and Tolerability of ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity.

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/CELG/pressreleases/34352916/celgenes-new-study-on-bms-986368-a-potential-game-changer-for-ms-treatment/

Celgene's New Study on BMS-986368: A Potential Game ... The study aims to evaluate the efficacy, safety, and tolerability of BMS-986368 in treating spasticity in multiple sclerosis patients, a ...

4. bmsstudyconnect.com bmsstudyconnect.com/br/en/clinical-trials/NCT06782490.html

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

5. tipranks.com tipranks.com/news/company-announcements/celgenes-promising-phase-2-study-on-bms-986368-for-multiple-sclerosis-spasticity

Celgene's Promising Phase 2 Study on BMS-986368 for ... The study aims to evaluate the efficacy, safety, and tolerability of BMS-986368 in treating spasticity associated with Multiple Sclerosis, a ...

6. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06782490

Trial ID IM045-1018 | NCT06782490 - BMS Clinical Trials The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity.

7. multiplesclerosisnewstoday.com multiplesclerosisnewstoday.com/news-posts/2025/07/18/new-global-trial-testing-oral-therapy-bms-986368-ms-spasticity/

New global trial testing oral therapy BMS-986368 for MS ... An international Phase 2 trial will test BMS-986368 as a potentially new oral therapy for managing multiple sclerosis-related spasticity.

8. trial.medpath.com trial.medpath.com/clinical-trial/6c2d6ace39ef7a88/nct06782490-bms-986368-faah-mgll-inhibitor-multiple-sclerosis-spasticity

A Study to Evaluate the Efficacy, Safety and Tolerability of ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity.