11C-BMS-986196 for Multiple Sclerosis

No longer recruiting at 4 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Benign MS, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 11C-BMS-986196 to assess its safety and behavior in the body. It focuses on individuals with multiple sclerosis (MS), a condition where the immune system affects the brain and spine. The trial includes two groups: healthy individuals and those with MS. People with MS, diagnosed based on standard criteria and experiencing symptoms that impact daily life, might be suitable candidates. The goal is to understand how the treatment moves through the body and its potential to help people with MS in the future. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that 11C-BMS-986196 is likely to be safe for humans?

Research shows that 11C-BMS-986196 is an experimental drug tested for safety when administered intravenously. This drug has not been approved for any conditions, including multiple sclerosis. Previous studies have not yet provided data on its tolerability or potential side effects.

As this study is in its early stages, it aims to gather initial safety information. Early-stage trials typically focus on determining a treatment's safety for humans, but they lack extensive data. Participants in this trial will help researchers learn more about any possible side effects or safety issues related to 11C-BMS-986196. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 11C-BMS-986196 because it offers a unique approach to understanding multiple sclerosis (MS) through advanced imaging techniques. Unlike standard MS treatments, which primarily aim to manage symptoms and slow disease progression, 11C-BMS-986196 is used to visualize how drugs are distributed and metabolized in the body, providing valuable insights into the disease process. This imaging agent could potentially reveal new targets for therapeutic intervention and help tailor treatments more precisely to individual patients, offering a more personalized approach to MS care.

What evidence suggests that 11C-BMS-986196 might be an effective treatment for multiple sclerosis?

Research has shown that 11C-BMS-986196 is under study for its potential to help treat multiple sclerosis (MS). This compound acts as a radiotracer, allowing doctors to visualize certain brain processes using imaging techniques like PET scans. Early findings suggest it attaches to specific brain areas, providing a clearer view of MS-related changes. In this trial, participants with MS will receive 11C-BMS-986196 to understand its effects in the body. Early human studies are crucial to determine its safety and effectiveness. Further research is needed to confirm these initial results and assess its impact on MS treatment. ^{1 2 3 5 6}

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 adults with a BMI of 18-34 kg/m2 and weight ≥50 kg. Healthy participants are needed, as well as those diagnosed with MS per the McDonald criteria, having an EDSS score of 0-6.5. People can't join if they've had recent surgery or have benign MS, spinal MS without brain lesions, or any significant illness.

Inclusion Criteria

My disability level is moderate, allowing me some daily activity.

For Parts A & B: Documentation of normal Allen's test result at Screening and on PET scanning days in the arm that will be used for arterial line placement

I am healthy with no significant medical issues based on my history, physical exams, ECGs, and lab tests.

Exclusion Criteria

I have a serious ongoing health issue.

My brain scans show no signs of inflammation.

I have mild MS and was diagnosed over 10 years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous administration of 11C-BMS-986196 and undergo PET-CT imaging

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 11C-BMS-986196

Trial Overview The study tests the safety and body distribution of a substance called 11C-BMS-986196 given through IV to healthy people and those with multiple sclerosis (MS). It looks at how the body processes this substance and its effects on the central nervous system.

How Is the Trial Designed?

Group I: Part B - Participants with MS Experimental Treatment 1 Intervention

Group II: Part A - Healthy Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

BMS-986001 was found to be safe and well tolerated in a study involving 64 healthy male subjects, with no serious adverse events reported and only 14.6% experiencing mild adverse effects that were not dose-related.

The pharmacokinetics of BMS-986001 showed a linear dose-exposure relationship, indicating consistent absorption and effectiveness across various doses, regardless of whether it was taken with or without food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects. Urata, Y., Paintsil, E., Cheng, YC., et al.[2014]

In a study involving 34 patients with advanced solid tumors, the maximum tolerated dose (MTD) of BMS-184476 was determined to be 60 mg/m2, with significant dose-limiting toxicities observed at higher doses, including severe neutropenia and diarrhea.

BMS-184476 demonstrated preliminary activity, with one patient showing a partial response and another a minor response, suggesting potential advantages over paclitaxel in terms of safety and pharmacokinetics, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. Hidalgo, M., Aylesworth, C., Hammond, LA., et al.[2018]

Citations

1. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT05064436.html

study connect - BMS Clinical Trials A study to evaluate the safety, tolerability, kinetics, biodistribution and repeatability of 11C-BMS-986196 after intravenous (IV) administration in healthy ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/36/NCT05064436/Prot_000.pdf

Official Title of Study: A Phase 1, Open-label, Multi-part ... Part B (Characterization of 11C-BMS-986196 binding in the human brain): Up to. 8 participants with MS will complete 2 evaluable cranial PET-CT ...

3. withpower.com withpower.com/trial/phase-1-multiple-sclerosis-9-2021-1b16a

A Study to Evaluate the Safety, Tolerability, Kinetics ... This Phase 1 medical study run by Bristol-Myers Squibb needs participants to evaluate whether 11C-BMS-986196 will have tolerable side effects & efficacy for ...

4. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/study-of-pet-ligand-11c-bms-986196-in-healthy-volunteers-and-ms-patien/

Study of PET Ligand 11C-BMS-986196 in Healthy ... The purpose of this study is to evaluate a new radioactive compound (radiotracer), 11C-BMS-986196, in healthy participants and participants with multiple ...

5. synapse.patsnap.com synapse.patsnap.com/drug/3a6377d9564f4dfa91afc95fb7fc7271

BMS-986196 - Drug Targets, Indications, Patents A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196

6. bmsstudyconnect.com bmsstudyconnect.com/dk/en/clinical-trials/NCT05064436.html

study connect - BMS Clinical Trials A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) ...