84 Participants NeededMy employer runs this trial

BMS-986528 for Rheumatoid Arthritis

Recruiting at 44 trial locations
BC
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BMS-986528, an experimental drug, to determine its safety and effectiveness for people with rheumatoid arthritis (RA) who struggle to find effective treatments. The researchers aim to learn about the drug's safety, how the body processes it, and any signs of disease improvement. Several groups will receive the treatment to gather diverse data. Those who have struggled with hard-to-treat RA, despite trying other treatments, might be a good fit for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

Is there any evidence suggesting that BMS-986528 is likely to be safe for humans?

Research has shown that BMS-986528 is undergoing tests to determine its safety and tolerability in individuals with hard-to-treat rheumatoid arthritis. Although detailed results from earlier studies are not available, this treatment is in the early testing stages, focusing primarily on human safety. Researchers closely monitor patient responses to the drug and record any side effects. Early trials prioritize safety before advancing to later stages. Therefore, while detailed safety data for BMS-986528 is not yet available, current studies primarily aim to ensure its safety.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-986528 for rheumatoid arthritis because it offers a novel approach compared to current treatments like methotrexate and biologics such as TNF inhibitors. Unlike these standard options, BMS-986528 targets a different pathway, possibly offering relief for patients who do not respond well to traditional therapies. Additionally, this new treatment may have a faster onset of action, providing quicker symptom relief. Its unique mechanism of action could also potentially lead to fewer side effects, making it a promising option for those seeking alternative therapies.

What evidence suggests that BMS-986528 might be an effective treatment for rheumatoid arthritis?

Research has shown that BMS-986528 could be a promising treatment for rheumatoid arthritis (RA). This trial will evaluate BMS-986528 across various treatment arms, each focusing on different aspects of its potential effects. The treatment targets parts of the immune system that may contribute to RA. Early results suggest that patients with difficult-to-treat RA might experience a decrease in symptoms. Although the full extent of its efficacy is still under investigation, BMS-986528 aims to adjust immune responses, potentially reducing inflammation and joint damage in RA patients. Further studies will provide a clearer picture of its effectiveness.12467

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with rheumatoid arthritis that has not responded to standard treatments and is hard to manage. People cannot join if they have juvenile arthritis, certain other pain conditions like active fibromyalgia, or if their diagnosis isn't clear.

Inclusion Criteria

I am an adult with rheumatoid arthritis that is hard to control.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply.
I have seronegative rheumatoid arthritis and may have polymyalgia rheumatica.
I developed arthritis before I turned 18.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986528 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986528

Trial Overview

The study is testing a new drug called BMS-986528 in people with tough-to-treat rheumatoid arthritis. It aims to see how safe the drug is, how it works in the body, and whether it can help improve symptoms.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Group I: Cohort B2Experimental Treatment1 Intervention
Group II: Cohort B1Experimental Treatment1 Intervention
Group III: Cohort A8Experimental Treatment1 Intervention
Group IV: Cohort A7Experimental Treatment1 Intervention
Group V: Cohort A6Experimental Treatment1 Intervention
Group VI: Cohort A5Experimental Treatment1 Intervention
Group VII: Cohort A4Experimental Treatment1 Intervention
Group VIII: Cohort A3Experimental Treatment1 Intervention
Group IX: Cohort A2Experimental Treatment1 Intervention
Group X: Cohort A1Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

A Study of BMS-986528 in Participants With Refractory ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of ...

A Study of BMS-986528 in Participants With Refractory ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of ...

A Study of BMS-986528 in Participants With Refractory ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary ...

Q1 2026 Results Presentation (with Appendix)

✦ Rheumatoid Arthritis. CD19 HD Allo CAR T. ✦ Autoimmune Diseases. CD19 TCE (BMS-986528) ... Data Source: IQVIA Xponent data thru 3/28/2026; Q1 ...

BMS-986528 - Drug Targets, Indications, Patents

... Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis. 100 Clinical Results associated with BMS-986528. Login to view more data. 100 ...

A Study of BMS-986528 in Participants With Refractory ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary ...

A Study of BMS-986528 in Participants With Refractory ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary ...