BMS-986368 for Multiple Sclerosis

(MSS Trial)

Recruiting at 47 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

Trial Summary

What is the purpose of this trial?

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

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.

What safety data exists for BMS-986368 in humans?

The available research does not provide specific safety data for BMS-986368. However, newer disease-modifying therapies for multiple sclerosis, in general, have been associated with safety concerns and require monitoring, as adverse events are observed in clinical trials and post-marketing reports. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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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

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis. [2021]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Disease modifying agents for multiple sclerosis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. [2022]

4. United States 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. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Newer Disease Modifying Therapies in Multiple Sclerosis. [2023]