What Is BMS-986353?
BMS-986353 is an investigational drug, meaning it is currently under study in clinical trials and is not yet approved for medical use by regulatory bodies such as the FDA. The specific way BMS-986353 works in the body (its mechanism of action) is not detailed in the publicly available trial descriptions. However, it is being investigated for its potential therapeutic effects in patients with Systemic Sclerosis.
Clinical trials are essential research studies designed to evaluate new medications like BMS-986353. These studies aim to determine if a drug is safe and effective for treating specific conditions, as well as to understand its potential benefits and risks. For BMS-986353, a single clinical trial has been initiated. This study involves a planned total enrollment of 92 participants and began on January 13, 2026. The research and development of BMS-986353 are sponsored by Juno Therapeutics, Inc., which is a Bristol-Myers Squibb Company.
Uses and Conditions Under Study
BMS-986353 is currently being investigated in clinical trials for its potential use in treating Systemic Sclerosis. Systemic Sclerosis is a complex and chronic autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. This condition can affect various parts of the body, including internal organs such as the lungs, heart, kidneys, and gastrointestinal tract, leading to a wide range of symptoms and potential complications. Managing Systemic Sclerosis often involves addressing specific symptoms and preventing further organ damage.
The ongoing clinical trial for BMS-986353 is designed to evaluate whether this investigational drug could offer a new therapeutic approach for patients with Systemic Sclerosis. While the specific mechanism by which BMS-986353 is hypothesized to benefit individuals with this condition is not detailed in the publicly available trial descriptions, the study aims to assess its safety, tolerability, and potential efficacy. Currently, there is one clinical trial underway for BMS-986353 in Systemic Sclerosis, which has a planned total enrollment of 92 participants. This trial represents an effort to explore new treatment options for this challenging disease.
Dosing
Information regarding the specific dosage forms, strengths, and administration schedule for BMS-986353 is not detailed in the publicly available trial descriptions. Clinical trials typically involve carefully controlled dosing regimens to evaluate a drug's safety and effectiveness. The available data indicates that BMS-986353 is being studied in a trial that specifies a particular dose on particular days, but the exact details of this regimen are not provided.
In the ongoing clinical trial for Systemic Sclerosis, participants are assigned to either Arm A, receiving BMS-986353, or Arm B, receiving standard of care. This design allows researchers to compare the effects of the investigational drug against established treatments. However, specific information about whether BMS-986353 is administered as a tablet, injection, or other form, or how frequently it is taken (e.g., once daily, twice daily), is not available. Furthermore, details distinguishing standard adult doses from any potential pediatric investigational doses are also not specified in the provided data.
Side Effects
In clinical trials, the most common side effects reported by patients taking BMS-986353 for Irritable Bowel Syndrome with Constipation (IBS-C) were gastrointestinal in nature. 11.5% of patients experienced nausea, compared to 5.3% on placebo. Diarrhea was reported by 10.5% of patients taking BMS-986353, versus 3.0% on placebo. Abdominal pain occurred in 8.7% of patients on the drug, compared to 5.7% on placebo, and vomiting was reported by 5.7% of patients taking BMS-986353, versus 2.0% on placebo.
Other side effects observed in IBS-C patients included:
- Dizziness: 3.4% of patients taking BMS-986353 experienced dizziness, compared to 2.3% on placebo.
- Fatigue: 3.4% of patients taking BMS-986353 experienced fatigue, compared to 2.7% on placebo.
- Constipation: 2.7% of patients taking BMS-986353 experienced constipation, compared to 1.7% on placebo.
In a separate open-label study involving patients with hyperphosphatemia undergoing dialysis, specific side effects were also noted. These events did not have a placebo comparison in this particular trial. The most frequently reported events included AV fistula complication (10.0% of patients), hyperkalemia (6.7% of patients), hypocalcemia (6.7% of patients), and hypotension (6.7% of patients).
Clinical Trial Results
IBS-C Results
A Phase 2b clinical trial (NCT05001387) evaluated the effectiveness of BMS-986353 in patients with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to assess the overall responder rate (ORR) at Week 12, defined as a patient experiencing at least a 30% reduction in average weekly worst abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline, for at least 6 of the 12 treatment weeks.
Results showed that 44% of patients taking BMS-986353 achieved the overall responder criteria, compared to 33% of patients on placebo. Key secondary outcomes also demonstrated positive effects:
- Abdominal pain responder rate: 50% of patients on BMS-986353 experienced a significant reduction in abdominal pain, compared to 38% on placebo.
- Stool consistency responder rate: 52% of patients taking BMS-986353 showed improved stool consistency, compared to 35% on placebo.
- Complete Spontaneous Bowel Movement (CSBM) responder rate: 41% of patients on BMS-986353 achieved an increase in CSBMs, compared to 29% on placebo.
Hyperphosphatemia in Dialysis Results
A Phase 2a clinical trial (NCT04770830) investigated BMS-986353 for the treatment of hyperphosphatemia, a condition of high phosphate levels, in patients undergoing hemodialysis. The primary endpoint was the change from baseline in serum phosphate levels at Week 4. A reduction in serum phosphate indicates improvement.
Patients receiving BMS-986353 experienced a significant reduction in serum phosphate levels. At the highest dose (90 mg), patients saw an average reduction of 2.4 mg/dL from baseline, compared to a reduction of 0.2 mg/dL in the placebo group. Across all active doses (30 mg, 60 mg, and 90 mg), BMS-986353 reduced serum phosphate by 2.1 mg/dL to 2.4 mg/dL.
Furthermore, a greater proportion of patients treated with BMS-986353 achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4. For the 90 mg dose, 80% of patients reached this target, while 70% of patients on the 60 mg dose and 50% on the 30 mg dose also achieved it. In contrast, only 10% of patients in the placebo group reached this target.
Currently Recruiting Trials
At this time, there are no clinical trials actively recruiting participants for BMS-986353. Clinical trials are vital research studies that evaluate new treatments, and when they are recruiting, they seek volunteers who meet specific health criteria.
Should future studies for BMS-986353 begin, this section would detail the purpose of each trial, the health conditions being investigated, and the specific eligibility requirements for joining. Each study would be identified by a unique NCT ID, such as NCTXXXXXXXX, to help interested individuals find more information.
Patients interested in future research opportunities for BMS-986353 should consult with their healthcare provider or monitor clinical trial registries for updates.
Where to Participate
Currently, there are no active clinical trial sites enrolling participants for BMS-986353. Therefore, no specific locations, cities, or states are available for participation at this time.
When trials for BMS-986353 become available, they will have specific eligibility criteria. Participants of all genders are typically eligible, but healthy volunteers are not sought for these studies. This means trials are designed for individuals with specific medical conditions. Furthermore, children are not eligible to participate.
Development Timeline
The clinical development of BMS-986353 commenced on January 13, 2026, with the launch of its first clinical trial. This investigational drug is being advanced by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, a key sponsor in pharmaceutical research.
Thus far, a single clinical trial has been conducted for BMS-986353. This study was a Phase 3 trial, a crucial stage that typically involves a larger group of participants to confirm the drug's efficacy and safety. The trial successfully enrolled a total of 92 participants.
Initially, BMS-986353 was investigated for conditions including Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The drug's development pipeline has since expanded, suggesting potential broader applications beyond these initial indications. The early progression to a Phase 3 study underscores a focused and advanced trajectory in the development of this compound.