BMS-986165 Dose 1 for Ulcerative Colitis

Local Institution - 0011, San Juan, Puerto Rico
Ulcerative ColitisBMS-986165 Dose 1 - Drug
Eligibility
18 - 65
All Sexes

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.

Eligible Conditions
  • Ulcerative Colitis

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline to Week 56

At Week 12
Proportion of participants in clinical response
Baseline to Week 56
Number of adverse events (AEs)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

BMS-986165
1 of 5
BMS-986165 Dose 1
1 of 5
BMS-986165 Dose 2
1 of 5
Open label Extension, BMS-986165
1 of 5
Placebo
1 of 5

Experimental Treatment

Non-Treatment Group

50 Total Participants · 5 Treatment Groups

Primary Treatment: BMS-986165 Dose 1 · Has Placebo Group · Phase 2

BMS-986165
Drug
Experimental Group · 1 Intervention: BMS-986165 · Intervention Types: Drug
BMS-986165 Dose 1
Drug
Experimental Group · 1 Intervention: BMS-986165 Dose 1 · Intervention Types: Drug
BMS-986165 Dose 2
Drug
Experimental Group · 1 Intervention: BMS-986165 Dose 2 · Intervention Types: Drug
Open label Extension, BMS-986165
Drug
Experimental Group · 1 Intervention: BMS-986165 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo Comparator · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986165
2020
Completed Phase 3
~2960

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 56

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,539 Previous Clinical Trials
4,019,411 Total Patients Enrolled
10 Trials studying Ulcerative Colitis
1,863 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18 - 65 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.