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Clinical Trial Results:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

Summary
EudraCT number	2017-001976-48
Trial protocol	GB HU FR ES PL DE DK PT NL BE IT RO
Global end of trial date	23 Oct 2023

Results information
Results version number	v1(current)
This version publication date	15 Jun 2024
First version publication date	15 Jun 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

IM011-023

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussee de la Hulpe 185, Brussels, Belgium, 1170

Public contact

Bristol-Myers Squibb International Corporation, EU Study Start-Up Unit, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

28 Nov 2023

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

23 Oct 2023

Was the trial ended prematurely?

No

Main objective of the trial

To assess the effect of BMS-986165 on clinical remission and endoscopic response at the end of the Induction Period (Week 12 [Day 85]).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

16 Jul 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 7

Country: Number of subjects enrolled

Belgium: 2

Country: Number of subjects enrolled

Brazil: 7

Country: Number of subjects enrolled

Canada: 3

Country: Number of subjects enrolled

China: 12

Country: Number of subjects enrolled

Czechia: 6

Country: Number of subjects enrolled

Denmark: 1

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Germany: 11

Country: Number of subjects enrolled

Hungary: 8

Country: Number of subjects enrolled

Ireland: 1

Country: Number of subjects enrolled

Israel: 1

Country: Number of subjects enrolled

Italy: 9

Country: Number of subjects enrolled

Japan: 20

Country: Number of subjects enrolled

Korea, Republic of: 1

Country: Number of subjects enrolled

Mexico: 4

Country: Number of subjects enrolled

Netherlands: 2

Country: Number of subjects enrolled

Poland: 37

Country: Number of subjects enrolled

Portugal: 1

Country: Number of subjects enrolled

Romania: 3

Country: Number of subjects enrolled

Russian Federation: 15

Country: Number of subjects enrolled

Spain: 5

Country: Number of subjects enrolled

Taiwan: 4

Country: Number of subjects enrolled

United Kingdom: 10

Country: Number of subjects enrolled

United States: 66

Worldwide total number of subjects

239

EEA total number of subjects

89

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

222

From 65 to 84 years

17

85 years and over

0

Subject disposition

Top of page

Recruitment details

239 participants were randomized to a study treatment, 235 participants were treated.

Screening details

Enrollment into the 12 mg BMS-986165 arm was discontinued. Participants who were randomized to 12 mg BMS-986165 were continued on their originally assigned double-blind study treatment. These participants completed all study procedures and assessments outlined in the current version of the protocol.

Period 1 title

Pre-Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Carer, Data analyst, Assessor, Subject

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take placebo twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the OLE Period and began/continued to receive BMS986165 6 mg twice daily.

Arm type

Placebo

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

Placebo matching BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

1 capsule taken twice per day.

3 mg BMS-986165

Arm description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take BMS-986165 3 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open-label extension period and began/continued to receive open label BMS-986165 6 mg twice daily.

Arm type

Experimental

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

3mg taken twice per day

6 mg BMS-986165

Arm description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 6 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to enter the open label period and continued to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period and continued to receive open label BMS-986165 6 mg twice daily.

Arm type

Experimental

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

12 mg BMS-986165

Arm description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 12 mg orally once daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg for the Maintenance Period, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period to receive open label BMS-986165 6 mg twice daily.

Arm type

Experimental

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

12 mg taken once per day

Number of subjects in period 1	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Started	60	86	84	9
Completed	59	84	83	9
Not completed	1	2	1	0
Consent withdrawn by subject	-	1	-	-
Other reasons	1	1	1	-

Period 2 title

Treatment Period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take placebo twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the OLE Period and began/continued to receive BMS986165 6 mg twice daily.

Arm type

Placebo

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

Placebo matching BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

1 capsule taken twice per day.

3 mg BMS-986165

Arm description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take BMS-986165 3 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open-label extension period and began/continued to receive open label BMS-986165 6 mg twice daily.

Arm type

Placebo

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

3mg taken twice per day

6 mg BMS-986165

Arm description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 6 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to enter the open label period and continued to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period and continued to receive open label BMS-986165 6 mg twice daily.

Arm type

Placebo

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

12 mg BMS-986165

Arm description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 12 mg orally once daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg for the Maintenance Period, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period to receive open label BMS-986165 6 mg twice daily.

Arm type

Placebo

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

6mg taken twice per day

Investigational medicinal product name

BMS-986165 oral capsule

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

12 mg taken once per day

Number of subjects in period 2	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Started	59	84	83	9
Completed	13	14	14	4
Not completed	46	70	69	5
Consent withdrawn by subject	5	11	16	1
Adverse event, non-fatal	11	20	18	2
Site terminated by sponsor	-	1	-	-
Study terminated by sponsor	7	20	15	-
Other reasons	4	6	7	-
Lost to follow-up	1	-	-	-
Lack of efficacy	18	12	13	2

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take placebo twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the OLE Period and began/continued to receive BMS986165 6 mg twice daily.

Reporting group title

3 mg BMS-986165

Reporting group description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take BMS-986165 3 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open-label extension period and began/continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

6 mg BMS-986165

Reporting group description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 6 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to enter the open label period and continued to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period and continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

12 mg BMS-986165

Reporting group description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 12 mg orally once daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg for the Maintenance Period, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period to receive open label BMS-986165 6 mg twice daily.

Reporting group values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165	Total
Number of subjects	60	86	84	9	239
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	52	81	80	9	222
From 65-84 years	8	5	4	0	17
85 years and over	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	39.1 ( 16.7 )	39.5 ( 15.2 )	37.9 ( 14.6 )	37.4 ( 13.7 )	-
Sex: Female, Male
Units: Participants
Female	22	38	34	3	97
Male	38	48	50	6	142
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	2	7	2	0	11
Not Hispanic or Latino	58	78	80	9	225
Unknown or Not Reported	0	1	2	0	3
Race/Ethnicity, Customized
Race
Units: Subjects
Asian	11	13	12	1	37
Black or African American	1	1	3	0	5
White	48	70	68	8	194
Other	0	2	0	0	2
Not Reported	0	0	1	0	1

End points

Top of page

Reporting group title

Placebo

Reporting group description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take placebo twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the OLE Period and began/continued to receive BMS986165 6 mg twice daily.

Reporting group title

3 mg BMS-986165

Reporting group description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take BMS-986165 3 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open-label extension period and began/continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

6 mg BMS-986165

Reporting group description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 6 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to enter the open label period and continued to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period and continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

12 mg BMS-986165

Reporting group description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 12 mg orally once daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg for the Maintenance Period, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period to receive open label BMS-986165 6 mg twice daily.

Reporting group title

Placebo

Reporting group description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take placebo twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders (Placebo) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the OLE Period and began/continued to receive BMS986165 6 mg twice daily.

Reporting group title

3 mg BMS-986165

Reporting group description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12 week induction period continued to take BMS-986165 3 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders (BMS-986165 3 mg) and week 12 non-responders (BMS-986165 6 mg OL) who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open-label extension period and began/continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

6 mg BMS-986165

Reporting group description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 6 mg orally twice daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to enter the open label period and continued to receive BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period and continued to receive open label BMS-986165 6 mg twice daily.

Reporting group title

12 mg BMS-986165

Reporting group description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after the 12-week induction period continued to take BMS-986165 12 mg orally once daily until the end of the maintenance period (week 52). Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day. Participants who were randomized prior to the implementation of Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg for the Maintenance Period, if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to enter the open label extension period to receive open label BMS-986165 6 mg twice daily.

Primary: Percent of participants achieving clinical remission at Week 12

Top of page

End point title

Percent of participants achieving clinical remission at Week 12

End point description

Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

End point type

Primary

End point timeframe

12 weeks after first dose

End point values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Number of subjects analysed	60	86	84	9
Units: Percent of Participants
number (confidence interval 95%)	28.3 (16.9 to 39.7)	32.6 (22.7 to 42.5)	21.4 (12.7 to 30.2)	22.2 (0.0 to 49.4)

Risk Difference (RD) Placebo vs 3 mg BMS-986165

Comparison groups

3 mg BMS-986165 v Placebo

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[1]

P-value

= 0.5812 ^[2]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

4.3

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

19.5

Notes
[1] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[2] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[3]

P-value

= 0.372 ^[4]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.5

Notes
[3] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[4] - Based on a 2-sided test at a significance level of 0.025.

Risk Difference (RD) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[5]

P-value

= 0.372 ^[6]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

-6.3

Confidence interval

level

95%

sides

2-sided

lower limit

-20.2

upper limit

7.6

Notes
[5] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[6] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[7]

P-value

= 0.5812 ^[8]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

2.5

Notes
[7] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[8] - Based on a 2-sided test at a significance level of 0.025.

Primary: Percent of participants achieving endoscopic response at Week 12

Top of page

End point title

Percent of participants achieving endoscopic response at Week 12

End point description

Endoscopic Response is defined as >= 50% decrease from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

End point type

Primary

End point timeframe

12 weeks after first dose

End point values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Number of subjects analysed	60	86	84	9
Units: Percent of Participants
number (confidence interval 95%)	8.3 (1.3 to 15.3)	23.3 (14.3 to 32.2)	16.7 (8.7 to 24.6)	33.3 (2.5 to 64.1)

Risk Difference (RD) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[9]

P-value

= 0.0198 ^[10]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

15

Confidence interval

level

95%

sides

2-sided

lower limit

3.7

upper limit

26.3

Notes
[9] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[10] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[11]

P-value

= 0.1584 ^[12]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

6.1

Notes
[11] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[12] - Based on a 2-sided test at a significance level of 0.025.

Risk Difference (RD) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[13]

P-value

= 0.1584 ^[14]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

8.2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

19

Notes
[13] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[14] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[15]

P-value

= 0.0198 ^[16]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

9.8

Notes
[15] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[16] - Based on a 2-sided test at a significance level of 0.025.

Secondary: Percent of participants achieving clinical response at Week 12

Top of page

End point title

Percent of participants achieving clinical response at Week 12

End point description

Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score < 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

End point type

Secondary

End point timeframe

12 weeks after first dose

End point values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Number of subjects analysed	60	86	84	9
Units: Percent of Participants
number (confidence interval 95%)	40.0 (27.6 to 52.4)	47.7 (37.1 to 58.2)	38.1 (27.7 to 48.5)	55.6 (23.1 to 88.0)

Risk Difference (RD) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[17]

P-value

= 0.3464 ^[18]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

7.7

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

23.6

Notes
[17] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[18] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[19]

P-value

= 0.3464 ^[20]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

2.8

Notes
[19] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[20] - Based on a 2-sided test at a significance level of 0.025.

Risk Difference (RD) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[21]

P-value

= 0.8857 ^[22]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-17

upper limit

14.7

Notes
[21] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[22] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[23]

P-value

= 0.8857 ^[24]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.9

Notes
[23] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[24] - Based on a 2-sided test at a significance level of 0.025.

Secondary: Percent of participants who achieving Patient Reported Outcomes 2 (PRO2) remission at Week 12

Top of page

End point title

Percent of participants who achieving Patient Reported Outcomes 2 (PRO2) remission at Week 12

End point description

The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is >/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

End point type

Secondary

End point timeframe

12 weeks after first dose

End point values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Number of subjects analysed	60	86	84	9
Units: Percent of Participants
number (confidence interval 95%)	25.0 (14.0 to 36.0)	32.6 (22.7 to 42.5)	20.2 (11.6 to 28.8)	33.3 (2.5 to 64.1)

Risk Difference (RD) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[25]

P-value

= 0.2841 ^[26]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

22.9

Notes
[25] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[26] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

^[27]

P-value

= 0.2841 ^[28]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

3.1

Notes
[27] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[28] - Based on a 2-sided test at a significance level of 0.025.

Risk Difference (RD) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[29]

P-value

= 0.5417 ^[30]

Method

Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

-4.2

Confidence interval

level

95%

sides

2-sided

lower limit

-17.6

upper limit

9.2

Notes
[29] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[30] - Based on a 2-sided test at a significance level of 0.025.

Odds Ratio (OR) Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

^[31]

P-value

= 0.5417 ^[32]

Method

Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.8

Notes
[31] - Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).
[32] - Based on a 2-sided test at a significance level of 0.025.

Secondary: Change from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 12

Top of page

End point title

Change from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 12

End point description

The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.

End point type

Secondary

End point timeframe

12 weeks after first dose

End point values	Placebo	3 mg BMS-986165	6 mg BMS-986165	12 mg BMS-986165
Number of subjects analysed	50	70	58	7
Units: Change in Score on a Scale
arithmetic mean (standard deviation)	-1.5 ( 4.3 )	-2.5 ( 6.5 )	-3.7 ( 5.5 )	-5.6 ( 8.5 )

ANCOVA Placebo vs 6 mg BMS-986165

Comparison groups

Placebo v 6 mg BMS-986165

Number of subjects included in analysis

108

Analysis specification

Pre-specified

Analysis type

^[33]

P-value

= 0.0177 ^[34]

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.1

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.95

Notes
[33] - Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.
[34] - Based on a 2-sided test at a significance level of 0.025.

ANCOVA Placebo vs 3 mg BMS-986165

Comparison groups

Placebo v 3 mg BMS-986165

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

^[35]

P-value

= 0.0428 ^[36]

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

-0.1

Variability estimate

Standard error of the mean

Dispersion value

0.92

Notes
[35] - Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.
[36] - Based on a 2-sided test at a significance level of 0.025.

Adverse events

Top of page

Timeframe for reporting adverse events

Serious Adverse Events (SAEs) and Other Non-Serious Adverse Events (NSAEs) were assessed from first dose to 30 days after last dose of study therapy (assessed up to approximately 63 months).

Adverse event reporting additional description

The number at risk for SAEs and NSAEs represents all participants that received at least 1 dose of study therapy or similar.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Placebo

Reporting group description

Placebo was taken twice per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take placebo twice daily until the end of week 52.

Reporting group title

3 mg BMS-986165

Reporting group description

BMS-986165 3 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 3 mg orally twice daily until the end of week 52.

Reporting group title

12 mg BMS-986165

Reporting group description

Participants who took 12 mg BMS-986165 up to week 12/52 who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to enter the open label period and received BMS-986165 12 mg once per day until week 104.

Reporting group title

12 mg BMS-986165

Reporting group description

BMS-986165 12 mg was taken orally once per day over 12 weeks. Participants who achieved a clinical response after week 12 continued to take BMS-986165 12 mg orally once daily until the end of week 52. Participants who did not achieve clinical response prior to protocol v 3 but had an appropriate safety profile were eligible to receive BMS-986165 12 mg once per day.

Reporting group title

6 mg BMS-986165

Reporting group description

Participants from the Placebo, 3 mg BMS-986165, and 6 mg BMS-986165 arms who did not achieve clinical response at week 12 but had an appropriate safety profile were eligible to receive open-label BMS-986165 6 mg twice per day until week 52. Week 12 responders and week 12 non-responders who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to begin/continue to receive BMS986165 6 mg twice daily. Participants who were randomized to the 12 mg BMS-986165 arm prior to Protocol v3.0 who had not yet reached Week 12 but had an appropriate safety profile could switch to open-label BMS-986165 6 mg if they did not achieve a clinical response at Week 12. Week 12 responders and week 12 non-responders from this arm who continued to derive a clinical benefit from their respective treatments at week 26/52 and week 52 respectively were eligible to receive open label BMS-986165 6 mg twice daily until week 104.

Reporting group title

6 mg BMS-986165

Reporting group description

BMS-986165 6 mg was taken orally twice per day over 12 weeks. Participants who achieved a clinical response after the week 12 continued to take BMS-986165 6 mg orally twice daily until the end of week 52.

Serious adverse events	Placebo	3 mg BMS-986165	12 mg BMS-986165	12 mg BMS-986165	6 mg BMS-986165	6 mg BMS-986165
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 59 (10.17%)	11 / 84 (13.10%)	1 / 6 (16.67%)	2 / 9 (22.22%)	15 / 161 (9.32%)	5 / 83 (6.02%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Accidental exposure to product
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Craniofacial injury
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Haematoma
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Microcytic anaemia
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Ileal perforation
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	3 / 59 (5.08%)	5 / 84 (5.95%)	0 / 6 (0.00%)	1 / 9 (11.11%)	6 / 161 (3.73%)	2 / 83 (2.41%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 0	0 / 1	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stomatitis necrotising
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic cytolysis
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute hepatic failure
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Norovirus infection
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypoglycaemia
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	3 mg BMS-986165	12 mg BMS-986165	12 mg BMS-986165	6 mg BMS-986165	6 mg BMS-986165
Total subjects affected by non serious adverse events
subjects affected / exposed	33 / 59 (55.93%)	55 / 84 (65.48%)	3 / 6 (50.00%)	7 / 9 (77.78%)	86 / 161 (53.42%)	55 / 83 (66.27%)
General disorders and administration site conditions
Asthenia
subjects affected / exposed	3 / 59 (5.08%)	2 / 84 (2.38%)	0 / 6 (0.00%)	1 / 9 (11.11%)	3 / 161 (1.86%)	1 / 83 (1.20%)
occurrences all number	3	3	0	1	4	1
Pyrexia
subjects affected / exposed	4 / 59 (6.78%)	4 / 84 (4.76%)	0 / 6 (0.00%)	0 / 9 (0.00%)	9 / 161 (5.59%)	7 / 83 (8.43%)
occurrences all number	4	5	0	0	13	9
Reproductive system and breast disorders
Breast haematoma
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	0	0	1	0	0	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	4 / 59 (6.78%)	2 / 84 (2.38%)	0 / 6 (0.00%)	0 / 9 (0.00%)	4 / 161 (2.48%)	6 / 83 (7.23%)
occurrences all number	4	2	0	0	4	7
Cough
subjects affected / exposed	1 / 59 (1.69%)	3 / 84 (3.57%)	1 / 6 (16.67%)	0 / 9 (0.00%)	1 / 161 (0.62%)	3 / 83 (3.61%)
occurrences all number	1	3	2	0	1	4
Injury, poisoning and procedural complications
Traumatic haemothorax
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	0	0	1	0	0	0
Thoracic vertebral fracture
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	0	0	1	0	0	0
Rib fracture
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	0	0	1	0	0	0
Cardiac disorders
Ventricular extrasystoles
subjects affected / exposed	1 / 59 (1.69%)	0 / 84 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	1	0	1	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	4 / 59 (6.78%)	6 / 84 (7.14%)	0 / 6 (0.00%)	0 / 9 (0.00%)	4 / 161 (2.48%)	5 / 83 (6.02%)
occurrences all number	4	7	0	0	4	5
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 59 (0.00%)	2 / 84 (2.38%)	0 / 6 (0.00%)	1 / 9 (11.11%)	2 / 161 (1.24%)	4 / 83 (4.82%)
occurrences all number	0	2	0	1	2	4
Iron deficiency anaemia
subjects affected / exposed	3 / 59 (5.08%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences all number	3	1	0	0	0	1
Lymphopenia
subjects affected / exposed	0 / 59 (0.00%)	2 / 84 (2.38%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 161 (0.62%)	0 / 83 (0.00%)
occurrences all number	0	2	0	2	1	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	3 / 59 (5.08%)	6 / 84 (7.14%)	0 / 6 (0.00%)	0 / 9 (0.00%)	10 / 161 (6.21%)	7 / 83 (8.43%)
occurrences all number	3	6	0	0	10	8
Aphthous ulcer
subjects affected / exposed	2 / 59 (3.39%)	3 / 84 (3.57%)	0 / 6 (0.00%)	0 / 9 (0.00%)	7 / 161 (4.35%)	8 / 83 (9.64%)
occurrences all number	2	3	0	0	8	11
Dyspepsia
subjects affected / exposed	3 / 59 (5.08%)	1 / 84 (1.19%)	0 / 6 (0.00%)	1 / 9 (11.11%)	2 / 161 (1.24%)	0 / 83 (0.00%)
occurrences all number	3	1	0	1	2	0
Mouth ulceration
subjects affected / exposed	0 / 59 (0.00%)	6 / 84 (7.14%)	0 / 6 (0.00%)	0 / 9 (0.00%)	7 / 161 (4.35%)	4 / 83 (4.82%)
occurrences all number	0	9	0	0	11	8
Nausea
subjects affected / exposed	4 / 59 (6.78%)	4 / 84 (4.76%)	0 / 6 (0.00%)	0 / 9 (0.00%)	5 / 161 (3.11%)	2 / 83 (2.41%)
occurrences all number	4	4	0	0	5	2
Proctalgia
subjects affected / exposed	1 / 59 (1.69%)	1 / 84 (1.19%)	0 / 6 (0.00%)	1 / 9 (11.11%)	2 / 161 (1.24%)	0 / 83 (0.00%)
occurrences all number	1	1	0	1	2	0
Vomiting
subjects affected / exposed	5 / 59 (8.47%)	2 / 84 (2.38%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 161 (1.24%)	2 / 83 (2.41%)
occurrences all number	5	2	0	0	2	2
Crohn's disease
subjects affected / exposed	9 / 59 (15.25%)	10 / 84 (11.90%)	0 / 6 (0.00%)	1 / 9 (11.11%)	17 / 161 (10.56%)	10 / 83 (12.05%)
occurrences all number	9	10	0	1	19	11
Hepatobiliary disorders
Hepatic cytolysis
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 161 (0.00%)	0 / 83 (0.00%)
occurrences all number	0	0	0	1	0	0
Skin and subcutaneous tissue disorders
Rash papular
subjects affected / exposed	0 / 59 (0.00%)	1 / 84 (1.19%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 161 (0.00%)	1 / 83 (1.20%)
occurrences all number	0	1	0	1	0	1
Rash
subjects affected / exposed	2 / 59 (3.39%)	5 / 84 (5.95%)	0 / 6 (0.00%)	0 / 9 (0.00%)	6 / 161 (3.73%)	5 / 83 (6.02%)
occurrences all number	2	6	0	0	8	5
Skin lesion
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 161 (0.62%)	1 / 83 (1.20%)
occurrences all number	0	0	0	1	1	1
Acne
subjects affected / exposed	2 / 59 (3.39%)	9 / 84 (10.71%)	0 / 6 (0.00%)	0 / 9 (0.00%)	5 / 161 (3.11%)	12 / 83 (14.46%)
occurrences all number	2	10	0	0	6	12
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 59 (8.47%)	5 / 84 (5.95%)	0 / 6 (0.00%)	1 / 9 (11.11%)	8 / 161 (4.97%)	6 / 83 (7.23%)
occurrences all number	7	6	0	2	9	6
Back pain
subjects affected / exposed	3 / 59 (5.08%)	1 / 84 (1.19%)	0 / 6 (0.00%)	0 / 9 (0.00%)	5 / 161 (3.11%)	2 / 83 (2.41%)
occurrences all number	3	2	0	0	6	2
Myalgia
subjects affected / exposed	0 / 59 (0.00%)	4 / 84 (4.76%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 161 (0.62%)	2 / 83 (2.41%)
occurrences all number	0	5	0	1	1	3
Infections and infestations
COVID-19
subjects affected / exposed	6 / 59 (10.17%)	5 / 84 (5.95%)	1 / 6 (16.67%)	0 / 9 (0.00%)	22 / 161 (13.66%)	11 / 83 (13.25%)
occurrences all number	6	6	1	0	23	11
Folliculitis
subjects affected / exposed	0 / 59 (0.00%)	5 / 84 (5.95%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 161 (0.62%)	1 / 83 (1.20%)
occurrences all number	0	5	0	0	1	1
Upper respiratory tract infection
subjects affected / exposed	2 / 59 (3.39%)	9 / 84 (10.71%)	1 / 6 (16.67%)	3 / 9 (33.33%)	11 / 161 (6.83%)	5 / 83 (6.02%)
occurrences all number	2	9	2	3	16	8
Nasopharyngitis
subjects affected / exposed	3 / 59 (5.08%)	6 / 84 (7.14%)	1 / 6 (16.67%)	0 / 9 (0.00%)	12 / 161 (7.45%)	5 / 83 (6.02%)
occurrences all number	4	8	2	0	18	5
Metabolism and nutrition disorders
Hypophosphataemia
subjects affected / exposed	0 / 59 (0.00%)	0 / 84 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 161 (0.62%)	2 / 83 (2.41%)
occurrences all number	0	0	0	1	2	2

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

24 May 2018

Includes modifications to multiple sections of the protocol to incorporate updated information, provide clarity, and to align with recent communications with FDA.

25 Jun 2019

Includes the following modifications: Change of co-primary endpoint (clinical remission) definition Removal of 12 mg QD treatment arm Addition of 52-week open-label extension period Clarification of clinical response, loss of response, and treatment failure definitions Clarification of corticosteroid tapering and rescue instructions Revision of the Schedule of Activities and Biomarker sections to provide clarity Update of Multiplicity Adjustment Section (10.4.6) Update of wording in various appendices to be consistent across studies of BMS-986165 Minor grammatical and typographic corrections

20 Aug 2019

Includes the following modifications: Clarification of the number of subject diary days required to calculate the CDAI Alignment in protocol text and Appendix 7 of washout times for specific treatments Clarification of rescreening requirements for subjects positive for C. difficile

06 Aug 2021

Includes the following modifications: Added information, instructions, and measures to be taken related to SARS-CoV-2 infection. Reconfigured secondary and exploratory endpoints in response to expert consensus on treatment targets in IBD. Added availability of a long-term extension study, IM011077, for eligible subjects. Removed exclusion criterion that prohibited the participation of subjects who had previously experienced inadequate response or loss of response to ustekinumab. Clarified multiple other inclusion and exclusion criteria. Updated vendor information Added efficacy and safety findings from recent BMS-986165 studies Removed fasting requirement at screening. Clarified procedures for C. difficile testing, endoscopies, unblinding for Week 12 analysis, hematocrit analysis, potential future analyses, and subjects with liver abnormalities and potential DILI AEs. Clarified that pharmacogenomic testing is optional. Clarified that subjects who need rescue treatment must discontinue study treatment during the OLE. Updated language throughout protocol to reflect current BMS procedures, policies, and guidelines.

02 Sep 2022

Includes the following modifications: Added diary selection rules for Week 0 of CDAI/PRO2 calculation Updated efficacy analyses to reflect updated planned statistical analyses Clarification of assessments and timing for Week 104 visit Clarification of final assessments for subjects rolling to IM011077, and these subjects will not be considered IM011023 study completers Elucidation of treatment failure rules Added open-label 6 mg BID BMS-986165 arm to the Selection and Timing of Dose table Applied minor editorial changes to enhance the clarity of the protocol and update address information

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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