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Unknown

Experimental Medication BMS-986165 for Crohn's Disease

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 week 12
Awards & highlights

Study Summary

This trial is testing a potential new Crohn's Disease treatment to see if it is safe and effective.

Who is the study for?
This trial is for adults with moderate to severe Crohn's Disease who haven't responded well to standard treatments. They must have been diagnosed at least 3 months ago and agree to use contraception if needed. People with other types of colitis, previous BMS-986165 use, or those likely needing surgery/hospitalization for their condition can't participate.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a new medication called BMS-986165 against a placebo in people with active Crohn's Disease. Participants will be randomly assigned to receive either the experimental drug or a placebo.See study design
What are the potential side effects?
Potential side effects from BMS-986165 are not specified here but typically could include immune system reactions, gastrointestinal symptoms, fatigue, and possible risks associated with new medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 achieving clinical remission at Week 12
Proportion of participants achieving endoscopic response at Week 12
Secondary outcome measures
Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12
Abdominal Pain
Proportion of participants who achieve a clinical response at Week 12

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: BMS-986165 Dose 2Experimental Treatment1 Intervention
Group II: BMS-986165 Dose 1Experimental 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
4,128,273 Total Patients Enrolled

Media Library

BMS-986165 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT03599622 — Phase 2
Crohn's Disease Research Study Groups: BMS-986165 Dose 2, BMS-986165 Dose 1, Placebo
Crohn's Disease Clinical Trial 2023: BMS-986165 Highlights & Side Effects. Trial Name: NCT03599622 — Phase 2
BMS-986165 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03599622 — Phase 2

Frequently Asked Questions

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

How many medical institutions are currently administering this experimental trial?

"Seventy patients are currently being recruited for this trial, including individuals from Local Institution - 0159 in Vancouver, Vanderbilt Inflammatory Bowel Disease Clinic in Nashville and a Local Institution based in New york. Additionally, there are 70 other sites participating as well."

Answered by AI

How many participants is this trial enrolling?

"Correct. The clinicaltrials.gov information indicates that recruitment is still underway for this trial, which was first shared on July 16th 2018 and last refreshed October 7th 2022. To fulfill the requirements of the study, 240 participants must be recruited from 70 different sites."

Answered by AI

Are applicants aged 18 or older allowed to join this clinical study?

"The eligibility requirements for this investigation excludes individuals under 18 and those over the age of 75. Separately, there are 73 separate clinical trials open to minors and 214 such studies available for older patients."

Answered by AI

Does this investigation offer any groundbreaking advances?

"Since 2018, research has been performed on BMS-986165. Initially funded by Bristol-Myers Squibb, the first trial was completed in 2018 with 240 patients and eventually granted Phase 2 drug approval. Currently there are 11 ongoing studies of this medication across 401 cities and 36 countries worldwide."

Answered by AI

Have any other clinical research studies previously utilized BMS-986165?

"BMS-986165 was first introduced to the scientific community in 2018 with H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia being at the forefront of its research. Since then, 18348 trials have been successfully completed and 11 more are currently enrolling patients - notably in Vancouver, British Columbia."

Answered by AI

Am I eligible to partake in this scientific trial?

"This trial is seeking 240 patients aged 18 to 75 years with granulomatous colitis. In order to qualify, applicants must demonstrate a documented case of Crohn's disease (CD) lasting at least 3 months, exhibiting either ileal, colonic or ilo-colonic symptoms and display active moderate to severe CD. Furthermore, males and females need to agree upon employing specific contraceptive methods when necessary."

Answered by AI

Has the FDA granted authorization for BMS-986165?

"Our team at Power rated the safety of BMS-986165 a 2, as its Phase 2 trial status implies some evidence for security but lacks information on efficacy."

Answered by AI

Is this trial still acquiring participants?

"Affirmative. Records on clinicaltrials.gov confirm that this medical trial, which initially launched on July 16th 2018, is actively enrolling patients. The study requires 240 participants to be recruited from 70 different sites around the world."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Florida Hospital Orlando
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
2018. "An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03599622.
~36 spots leftby Apr 2025
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