What side effects are associated with this type of intervention?

Common treatments for ulcerative colitis include glucocorticoids, 5-ASA agents, and biologics such as anti-TNF agents. Glucocorticoids can cause systemic side effects like adrenal suppression, especially with long-term use. 5-ASA agents, such as mesalamine, may cause nausea, headache, and rash. Biologics, including anti-TNF agents, can lead to increased risk of infections, infusion reactions, and potential development of antibodies against the drug. For treatments similar to Deucravacitinib, selective TYK2 inhibitors may have side effects such as increased risk of infections, liver enzyme elevations, and potential gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for moderate to severe Ulcerative Colitis, including biologics like infliximab and adalimumab, which are anti-TNF agents. Other biologics such as ustekinumab (an IL-12/23 inhibitor) and vedolizumab (an integrin receptor antagonist) have also been approved. Small molecules like tofacitinib, a Janus kinase (JAK) inhibitor, are similar to Deucravacitinib in targeting intracellular signaling pathways. These treatments aim to reduce inflammation and maintain remission in patients with Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Ulcerative Colitis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown efficacy in immune-mediated disorders. 2) Vedolizumab, an antibody to the alpha4beta7 integrin, used for induction and maintenance therapy in inflammatory bowel diseases. 3) Risankizumab, targeting interleukin-23, which has demonstrated positive results in phase 3 trials for Crohn's disease and may be applicable to UC.

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Janus Kinase (JAK) Inhibitor

BMS-986165 for Ulcerative Colitis

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

Summary

This trial is testing a new oral medication called BMS-986165 for people with moderate to severe ulcerative colitis. The medication aims to reduce inflammation by blocking certain signals in the body. The study will check how safe and effective the medication is over several weeks, followed by a phase where all participants receive the active treatment.

Who is the study for?

This trial is for adults with moderate to severe ulcerative colitis, diagnosed at least 3 months ago. Participants must have tried standard treatments without success or could not tolerate them. They should agree to use contraception if needed and cannot join if they've had significant colon surgery, are pregnant/breastfeeding, or have certain other bowel conditions.

What is being tested?

The study tests the safety and effectiveness of BMS-986165, an oral medication for ulcerative colitis. Initially comparing two doses against a placebo for 12 weeks, it now continues with all subjects receiving the drug in an open-label extension after one dose arm was removed.

What are the potential side effects?

While specific side effects aren't listed here, participants may experience issues related to the digestive system due to the nature of their condition and treatment type. Other common drug-related side effects might include headaches, nausea, fatigue or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Experiencing Adverse Events (AEs)

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

Number of Participants Experiencing Adverse Events of Special Interest (AEIs)

+2 more

Secondary study objectives

Number of adverse events (AEs)

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462

18%

Upper respiratory tract infection

Mouth ulceration

Nasopharyngitis

Pruritus

Headache

Folliculitis

Psoriasis

Cholecystitis

Pharyngitis

Gastroenteritis

Gastroenteritis shigella

Diabetes mellitus

Accidental overdose

Hepatobiliary procedural complication

Psoriatic arthropathy

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Week 0 up to Week 16

BMS-986165 Week 0 up to Week 52

BMS-986165 Week 16 up to Week 52

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open label Extension, BMS-986165Experimental Treatment1 Intervention

Group II: BMS-986165Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986165

2020

Completed Phase 3

~2990

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) primarily focus on modulating the immune system to reduce inflammation. Deucravacitinib, a selective TYK2 inhibitor, targets specific cytokine signaling pathways involved in the inflammatory process. TNF inhibitors like infliximab and adalimumab block TNF-alpha, a key cytokine in promoting inflammation. Thiopurines such as azathioprine and 6-mercaptopurine broadly suppress the immune system. These mechanisms are vital for UC patients as they help in reducing inflammation, managing symptoms, and improving quality of life.

Novel topical therapies for distal colitis.