BMS-986165 for Granulomatous Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Granulomatous Colitis+5 More
BMS-986165 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Granulomatous Colitis
  • Crohn Disease
  • Granulomatous Enteritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Week 12

Week 12
Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12
Proportion of participants achieving clinical remission at Week 12
Proportion of participants achieving deep remission at Week 12
Proportion of participants achieving endoscopic normalization at Week 12
Proportion of participants achieving endoscopic remission at Week 12
Proportion of participants achieving endoscopic response at Week 12
Abdominal Pain
Proportion of participants who achieve a clinical response at Week 12

Trial Safety

Safety Progress

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

Side Effects for

Arm 1: BMS-986165
18%Upper respiratory tract infection
8%Mouth ulceration
7%Nasopharyngitis
5%Headache
4%Pruritus
3%Psoriasis
1%Gastroenteritis shigella
1%Accidental overdose
1%Psoriatic arthropathy
1%Cholecystitis
1%Hepatobiliary procedural complication
1%Gastroenteritis
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT04167462) in the Arm 1: BMS-986165 ARM group. Side effects include: Upper respiratory tract infection with 18%, Mouth ulceration with 8%, Nasopharyngitis with 7%, Headache with 5%, Pruritus with 4%.

Trial Design

3 Treatment Groups

BMS-986165 Dose 2
1 of 3
BMS-986165 Dose 1
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

240 Total Participants · 3 Treatment Groups

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

BMS-986165 Dose 2
Drug
Experimental Group · 1 Intervention: BMS-986165 · Intervention Types: Drug
BMS-986165 Dose 1
Drug
Experimental Group · 1 Intervention: BMS-986165 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,919,349 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Men and women must agree to follow specific methods of contraception, if applicable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.