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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
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial will test if an experimental drug is safe and effective for people with moderate to severe ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
To learn more about participating in the clinical trial by Bristol-Myers Squibb, please visit www.BMSStudyConnect.com.
Select...
You have ulcerative colitis that affects at least 15 centimeters of your colon, which will be confirmed by a colonoscopy or sigmoidoscopy before the start of the study.
Select...
You have been diagnosed with ulcerative colitis for at least 3 months before the screening.
Select...
You must have moderate to severe ulcerative colitis, which is a type of inflammatory bowel disease, as determined by certain symptoms and a diagnostic test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Remission Response Rate at Week 12
Secondary outcome measures
Clinical Response Rate at 12 Weeks
Endoscopic Response at Week 12
Histological Improvement Response Rate at 12 Weeks

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986165Experimental Treatment1 Intervention
Group II: 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
2,629 Previous Clinical Trials
4,126,405 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
8,521 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

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

Is BMS-986165 a reliable treatment option with minimal risk?

"BMS-986165 scores a 2 on our Power scale due to the preliminary safety data, but there is no evidence of efficacy yet."

Answered by AI

Are participants still being welcomed for this experiment?

"At present, this particular clinical trial is not enrolling any more patients. It was initially posted on July 1st 2019 and last edited November 27th 2022. If you are searching for other studies related to ulcer or BMS-986165, there are 408 trials recruiting participants afflicted with the former condition and 11 trials actively seeking individuals for the latter medication."

Answered by AI

Could you elucidate on other investigations which have utilized BMS-986165?

"BMS-986165 was initially tested in 2018 at Gastromed and has since accrued a total of 18,353 completed trials. Currently, 11 more studies are actively enrolling participants with the majority hosted by medical centres in Las Vegas, Nevada."

Answered by AI

Are any medical centers in North America currently conducting this research?

"This medical research study is being conducted across 41 different sites. Examples of locations that are participating include Local Institution - 0002 in Las Vegas, Local Institution- 0048 in New Port Richey and Local Institution - 0121 in Glenview as well as numerous other facilities."

Answered by AI

Who meets the criteria for enrollment in this experiment?

"This clinical trial is currently accepting applicants between the ages of 18 and 80 who have been diagnosed with ulcer. 131 participants are expected to be recruited for this opportunity."

Answered by AI

How many volunteers are engaged in this clinical experiment?

"This trial is no longer open to new participants as it was last modified on November 27th 2022. However, if you're seeking other clinical studies related to ulcers or BMS-986165, there are 408 and 11 such experiments accepting enrollees respectively."

Answered by AI

Does this experimental protocol specify any age restrictions?

"Eligible participants for this trial must have an age range between 18 to 80. Patients younger than 18 can seek out the 71 clinical trials tailored to their demographic, while seniors over 65 have access to 357 studies that meet their criteria."

Answered by AI

Is this a pioneering research project?

"Investigated since 2018, BMS-986165 has been developed under the aegis of Bristol-Myers Squibb. After 240 participants participated in its initial clinical trial in 2018, the drug was approved for Phase 2 testing. Currently, 36 nations and 401 cities are hosting 11 active trials involving this compound."

Answered by AI
~23 spots leftby Mar 2025