Trial Outcomes & Findings for A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis (NCT NCT04613518)

Last Updated: 2024-07-12

Results Overview

Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) * 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 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: * Stool frequency (SF) subscore (0 to 3) * Rectal bleeding (RB) subscore (0 to 3) * Endoscopic (ES) subscore (0 to 3)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

At week 12

Results posted on

2024-07-12

Participant Flow

BMS-986165 6 mg BID arm was removed under Protocol Amendment 02.

Participant milestones

Participant milestones
Measure	BMS-986165 12 mg BID Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	BMS-986165 6 mg BID Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.	Placebo BID PO Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Double-Blind Treatment Period STARTED	26	4	8
Double-Blind Treatment Period COMPLETED	19	3	7
Double-Blind Treatment Period NOT COMPLETED	7	1	1
Open-Label Treatment Period STARTED	19	3	7
Open-Label Treatment Period COMPLETED	11	0	1
Open-Label Treatment Period NOT COMPLETED	8	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS-986165 12 mg BID Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	BMS-986165 6 mg BID Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.	Placebo BID PO Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Double-Blind Treatment Period Lack of Efficacy	1	0	0
Double-Blind Treatment Period Adverse Event	2	0	1
Double-Blind Treatment Period Participant request to discontinue treatment	1	0	0
Double-Blind Treatment Period Participant withdrew consent	1	1	0
Double-Blind Treatment Period Other Reasons	2	0	0
Open-Label Treatment Period Lack of Efficacy	0	3	0
Open-Label Treatment Period Adverse Event	1	0	3
Open-Label Treatment Period Participant request to discontinue treatment	1	0	0
Open-Label Treatment Period Participant withdrew consent	1	0	3
Open-Label Treatment Period Administrative reason by sponsor	4	0	0
Open-Label Treatment Period Other reasons	1	0	0

Baseline Characteristics

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	BMS-986165 6 mg BID n=4 Participants Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Total n=38 Participants Total of all reporting groups
Age, Continuous	41.8 Years STANDARD_DEVIATION 14.4 • n=5 Participants	28.8 Years STANDARD_DEVIATION 6.7 • n=7 Participants	38.0 Years STANDARD_DEVIATION 15.1 • n=5 Participants	39.6 Years STANDARD_DEVIATION 14.2 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: At week 12

Population: Prespecified to be collected for all randomized participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02.

Outcome measures

Outcome measures
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Percentage of Participants in Clinical Response at Week 12	53.8 Percentage of participants Interval 33.4 to 73.4	50.0 Percentage of participants Interval 15.7 to 84.3

PRIMARY outcome

Timeframe: From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

Population: All randomized participants who receive at least 1 dose of double-blind study treatment. Prespecified to be collected for participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02.

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

Outcome measures

Outcome measures
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Number of Participants Experiencing Adverse Events (AEs) Double-Blind Treatment Period	21 Participants	6 Participants
Number of Participants Experiencing Adverse Events (AEs) Open-Label Treatment Period	15 Participants	6 Participants

PRIMARY outcome

An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

Outcome measures

Outcome measures
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Number of Participants Experiencing Serious Adverse Events (SAEs) Double-Blind Treatment Period	4 Participants	1 Participants
Number of Participants Experiencing Serious Adverse Events (SAEs) Open-Label Treatment Period	1 Participants	1 Participants

PRIMARY outcome

Outcome measures

Outcome measures
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation Double-Blind Treatment Period	2 Participants	0 Participants
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation Open-Label Treatment Period	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From first dose to 52 weeks after first dose

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.

Outcome measures

Outcome measures
Measure	BMS-986165 12 mg BID n=26 Participants Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.	Placebo BID PO n=8 Participants Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Skin Events	15 Participants	5 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Influenza	1 Participants	2 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Herpes Viral Infections	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Opportunistic Infections	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Tuberculosis	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Cardiovascular events	1 Participants	0 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) Malignancy	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events of Special Interest (AEIs) COVID-19	3 Participants	0 Participants

Adverse Events

BMS-986165 12 mg BID (Double-Blind Treatment Period)

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

BMS-986165 6 mg BID (Double-Blind Treatment Period)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo BID PO (Double-Blind Treatment Period)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

BMS-986165 6 mg BID (Open-Label Treatment Period)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BMS-986165 12 mg BID (Double-Blind Treatment Period) n=26 participants at risk Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period.	BMS-986165 6 mg BID (Double-Blind Treatment Period) n=4 participants at risk Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period.	Placebo BID PO (Double-Blind Treatment Period) n=8 participants at risk Participants receive placebo for a 12-week double-blind treatment period.	BMS-986165 6 mg BID (Open-Label Treatment Period) n=29 participants at risk Eligible participants that move into the 40-week open-label extension period receive BMS-986165 6 mg BID PO.
Gastrointestinal disorders Anal fissure	0.00% 0/26 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/4 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/8 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	3.4% 1/29 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
Gastrointestinal disorders Colitis ulcerative	7.7% 2/26 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/4 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	12.5% 1/8 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	3.4% 1/29 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
Infections and infestations Bacteroides bacteraemia	3.8% 1/26 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/4 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/8 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/29 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
Renal and urinary disorders Nephrolithiasis	3.8% 1/26 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/4 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/8 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/29 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
Vascular disorders Deep vein thrombosis	3.8% 1/26 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/4 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/8 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)	0.00% 0/29 • All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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Restriction type: OTHER