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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 baseline to week 56
Awards & highlights

Study Summary

This trial is testing a new drug for ulcerative colitis. The study was designed to compare the new drug to a placebo, but one of the dose treatment arms is being removed from the 12-week double blind period.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants in clinical response
Secondary outcome measures
Number of adverse events (AEs)

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462
18%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,476 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
8,652 Patients Enrolled for Ulcerative Colitis

Media Library

Ulcerative Colitis Research Study Groups: BMS-986165, Placebo, Open label Extension, BMS-986165
BMS-986165 (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613518 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation for this research?

"Affirmative. According to clinicaltrials.gov, this medical study is still recruiting participants as of November 21st 2022. The trial was posted on March 15th 2021 and requires a total of 50 enrollees from 23 distinct locations."

Answered by AI

Has BMS-986165 Dose 1 been studied in any other contexts?

"BMS-986165 Dose 1 was initially studied in 2018 at Gastromed and subsequent trials have yielded 141 complete studies. Currently, 11 active clinical trials are underway across London, Ontario with more planned for the future."

Answered by AI

Who is eligible to participate in the research study?

"For admittance to this study, candidates must be diagnosed with colitis or ulcerative and between the ages of 18-65. Presently, there is a need for 50 participants."

Answered by AI

Is the patient age requirement for this clinical trial inclusive of octogenarians?

"As indicated by the criteria, only individuals aged between 18 and 65 are eligible for this trial. Conversely, there are 66 studies recruiting minors and 351 clinical trials that accept elderly patients."

Answered by AI

Are there any healthcare facilities in this state currently conducting this trial?

"This clinical analysis is allowing individuals to enroll from Local Institution in London, Ontario; Illinois Gastroenterology Group - Arlington Heights in Arlington Heights, IL; Lubbock Digestive Disease Associates in San Diego, CA and an additional 23 sites."

Answered by AI

Is this trial pioneering or has it been attempted before?

"BMS-986165 Dose 1 has recently been subject to 141 clinical trials, with the first study being conducted in 2018. Sponsored by Bristol-Myers Squibb, this drug was tested on 240 patients across 401 cities and 36 countries during its Phase 2 approval stage. Currently there are 11 active studies for BMS-986165 Dose 1."

Answered by AI

Is there an opportunity to join this experiment presently?

"As seen on clinicaltrials.gov, this medical experiment is presently gathering participants and has been since March 15th 2021 when it was initially posted. The study details were most recently updated on November 21st 2022."

Answered by AI

Has the Food and Drug Administration approved BMS-986165 Dose 1 for medical use?

"Despite the lack of evidence for efficacy, there is sufficient data to indicate BMS-986165 Dose 1's safety rating at a 2 on our scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
2021. "A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04613518.
~9 spots leftby Apr 2025
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