Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224801

Enrollment

120

Registered

2019-07-25

Start date

2019-07-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

BMS-986165:Specified Dose on Specified Days Placebo:Specified Dose on Specified Days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Active UC extending >= 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit -Documented diagnosis of UC of at least 3 months duration prior to screening -Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points, inclusive (modified Mayo score range = 0 to 9 points), which includes all of the following subscore values: A stool frequency (SF) subscore of >= 2, and A rectal bleeding (RB) subscore >= 1, and An endoscopic (ES) subscore of >= 2 (screening endoscopy)

Exclusion criteria

Exclusion criteria: -Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile]) -Stool positive for C. difficile toxin at screening visit -Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Design outcomes

Primary

Measure	Time frame
Clinical Remission Response Rate at Week 12 calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score = 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score <= 1 (modified, excludes friability)	—

Secondary

Measure	Time frame
-Clinical Response Rate at 12 Weeks defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore. It will be defined as the following: A decrease from baseline in the modified Mayo score of >= 2 points, and A decrease from baseline in the modified Mayo score >= 30%, and A decrease in rectal bleeding(RB) subscore of >= 1 point or absolute RB subscore <= 1 -Endoscopic Response rate at Week 12 defined as endscopic subscore<= 1 -Endoscopic Remission rate at Week 12 defined as an endoscopic subscore of 0	—

Measure

Time frame

-Clinical Response Rate at 12 Weeks defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore. It will be defined as the following: A decrease from baseline in the modified Mayo score of >= 2 points, and A decrease from baseline in the modified Mayo score >= 30%, and A decrease in rectal bleeding(RB) subscore of >= 1 point or absolute RB subscore <= 1 -Endoscopic Response rate at Week 12 defined as endscopic subscore<= 1 -Endoscopic Remission rate at Week 12 defined as an endoscopic subscore of 0

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Countries

Australia, Belgium, Czechia, France, Germany, Hungary, Italy, Korea, Poland, Russia, UK, USA

Contacts

Public ContactAntoine G. Sreih

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026