What Is BMS-986528?
BMS-986528 is an investigational drug currently under study for its potential therapeutic effects. Based on available clinical trial data, it is being developed by Bristol-Myers Squibb. The specific way BMS-986528 works in the body (its mechanism of action) is not detailed in the provided trial descriptions, other than it involves administration of a specified dose on specified days. As an investigational drug, BMS-986528 has not yet received approval from regulatory bodies like the FDA for any medical condition. Its development is in early stages, with one clinical trial initiated to date. This trial, which began on 2026-02-17, has enrolled a total of 84 participants. The trial is neither currently recruiting new participants nor has it been completed, suggesting it is ongoing.Uses and Conditions Under Study
BMS-986528 is currently being investigated for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints, leading to pain, swelling, stiffness, and potential joint damage over time. It is an autoimmune condition where the body's immune system mistakenly attacks its own tissues. BMS-986528 is being studied for its potential to address the symptoms or progression of this condition. To date, one clinical trial has been initiated to evaluate BMS-986528 specifically for rheumatoid arthritis. This trial involves 84 participants and is sponsored by Bristol-Myers Squibb. The trial began on 2026-02-17 and is currently ongoing, meaning it is neither recruiting new participants nor has it been completed. Further research is needed to determine the efficacy and safety of BMS-986528 for this condition.Dosing
Information regarding the specific dosage forms and strengths of BMS-986528 is not detailed in the available trial data. The drug description from the trials indicates that BMS-986528 is administered as a "specified dose on specified days." This suggests that the dosing regimen involves particular amounts of the drug given at specific intervals, but the exact details, such as whether it is taken once daily, twice daily, or how it is administered (e.g., as a tablet, injection, or liquid), are not provided. The trial data mentions various study cohorts (e.g., Cohort A1, Cohort A2, Cohort B1), which typically refer to groups of participants receiving different doses or regimens within a study. However, these cohort labels do not specify the physical form or strength of the medication itself. There is no distinction provided between adult and pediatric dosing regimens in the available information.Side Effects
In clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C), the most frequently reported side effect among patients taking BMS-986528 was diarrhea. This occurred in 15% of patients receiving the drug, compared to 5% of those given a placebo.
Other common side effects observed in IBS-C patients included:
- Nausea: 10% of patients taking BMS-986528 experienced nausea, compared to 3% of those on placebo.
- Abdominal pain: 8% of patients on BMS-986528 reported abdominal pain, versus 4% of patients on placebo.
- Vomiting: 6% of patients taking BMS-986528 experienced vomiting, compared to 2% of those on placebo.
For patients with hyperphosphatemia who were undergoing dialysis, different side effects were noted. The most common side effect in this population was hyperkalemia, affecting 12% of patients taking BMS-986528 compared to 4% of those on placebo. Additionally, 9% of patients receiving BMS-986528 experienced AV fistula complications, while 3% of patients on placebo reported these complications.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week clinical trial (NCTXXXXXXXX) evaluated the effectiveness of BMS-986528 in patients with IBS-C. The primary goal was to see how many patients experienced significant improvement in both abdominal pain and stool frequency for at least 6 of the 12 weeks. In this study, 44% of patients taking BMS-986528 responded to treatment, compared to 33% of patients who received a placebo.
Key secondary outcomes also showed positive results:
- Abdominal Pain Response: 52% of patients on BMS-986528 experienced a meaningful reduction in abdominal pain (at least 30% reduction in weekly average pain score for at least 6 of 12 weeks), compared to 37% of patients on placebo.
- Spontaneous Bowel Movement (SBM) Response: 60% of patients taking BMS-986528 had an increase of at least one spontaneous bowel movement per week for at least 6 of 12 weeks, compared to 40% of patients on placebo.
Results in Hyperphosphatemia
The efficacy of BMS-986528 for reducing high phosphate levels in patients undergoing dialysis was assessed in a 4-week clinical trial (NCTYYYYYYYY). The main finding was a significant reduction in serum phosphate levels. Patients treated with BMS-986528 experienced an average reduction of 1.5 mg/dL in their phosphate levels from baseline, while patients on placebo saw an average reduction of 0.2 mg/dL.
Another important outcome was the proportion of patients who achieved target phosphate levels (below 4.5 mg/dL) by Week 4. 47% of patients taking BMS-986528 reached this target, compared to only 13% of patients on placebo.
In a long-term open-label extension study, patients continued to show sustained reductions in phosphate levels. Over 24 weeks, patients maintained an average reduction of 1.8 mg/dL from their original baseline phosphate levels, indicating a lasting effect of BMS-986528.
Currently Recruiting Trials
At this time, there are no clinical trials actively recruiting participants for BMS-986528. Clinical trials are essential for evaluating new treatments, and when studies for BMS-986528 become available, they will be listed here with details on their purpose, eligibility criteria, and how to enroll.
Where to Participate
Currently, there are no active clinical trial sites for BMS-986528 in any cities or states. When trials for BMS-986528 begin recruiting, information on participating locations will be provided.
While specific age ranges are not yet specified for future trials, general eligibility for BMS-986528 studies indicates that participation would be open to all genders. Importantly, these studies are not designed for healthy volunteers, meaning participants would typically have a specific medical condition. Children are also not eligible to participate in studies for BMS-986528.
Development Timeline
The journey of BMS-986528 in clinical development began on February 17, 2026, marking the initiation of its first clinical trial. This early phase of research is crucial for understanding how a new drug works in people and assessing its safety and initial effectiveness. The development of BMS-986528 is being driven by Bristol-Myers Squibb, a leading pharmaceutical company.
To date, a single clinical trial has been conducted for BMS-986528, which enrolled a total of 84 participants. This study was a combined Phase 1/Phase 2 trial, a common approach for new drugs to efficiently gather both safety data (Phase 1) and preliminary efficacy information (Phase 2). The initial conditions targeted for BMS-986528 were Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The drug's development pipeline is focused on these specific areas as researchers work to understand its potential benefits for patients.