Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis (NCT NCT04877990)

NCT ID: NCT04877990

Last Updated: 2024-09-24

Results Overview

Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: From first dose to 30 days post last dose (Up to 110 weeks)
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	Crohn's Disease Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Pre-treatment STARTED	26	41
Pre-treatment COMPLETED	24	41
Pre-treatment NOT COMPLETED	2	0
Treatment STARTED	24	41
Treatment COMPLETED	0	0
Treatment NOT COMPLETED	24	41

Reasons for withdrawal

Measure	Crohn's Disease Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Treatment Other reasons	3	1
Treatment Administrative reasons by sponsor	17	33
Treatment Withdrawal by Subject	2	6
Treatment Adverse Event	2	1

Baseline Characteristics

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Baseline characteristics by cohort

Measure	Crohn's Disease n=26 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Total n=67 Participants Total of all reporting groups
Age, Continuous	38.7 Years STANDARD_DEVIATION 14.08 • n=5 Participants	44.3 Years STANDARD_DEVIATION 15.70 • n=7 Participants	42.2 Years STANDARD_DEVIATION 15.24 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	35 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	38 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)

Population: All treated participants

Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment

Outcome measures

Measure	Crohn's Disease n=24 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TEAEs	18 Participants	19 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TESAEs	2 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to study discontinuation	1 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) AEs of Interest - Skin-related events	0 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) AEs of Interest - Creatine Kinase events	2 Participants	3 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)

Population: All treated participants with laboratory measurements

Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.

Outcome measures

Measure	Crohn's Disease n=23 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Number of Participants With Laboratory Abnormalities Sodium < 130 or > 150 MEQ/L (MMOL/L)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Potassium < 3 or > 5.5 MEQ/L (MMOL/L)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Calcium > 12.5 MG/DL	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Albumin < 2.0 G/DL	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Creatine Kinase > 10xupper limit of normal	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Hemoglobin < 7.0 G/DL or > 30% reduction from baseline	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Neutrophil Count < 0.75 x 10^9/L	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Platelet Count < 75 x 10^9/L or > 999 x 10^9/L	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Serum Creatinine Increase > 50% and > 44.2 UMOL/L	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Hematocrit < 20% or 30% reduction from baseline	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities White Blood Cell Count < 1.5 x 10^9/L or > 35 x 10^9/L	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Lymphocyte Count < 0.5 x 10^9/L	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)

Population: All treated participants with ECG measurements

Outcome measures

Measure	Crohn's Disease n=24 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Number of Participants With Electrocardiogram (ECG) Abnormalities QTCF (MSEC) 450 - < 480	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTCF (MSEC) 480 - < 500	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities 30 < CHANGE FROM IM011077 STUDY BASELINE <= 60 MSEC	3 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities CHANGE FROM IM011077 STUDY BASELINE > 60 MSEC	3 Participants	5 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities PRAG (MSEC) P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QRSAG(MSEC) QRS INTERVAL >= 200 MSEC	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTCF (MSEC) >= 500	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 110 weeks)

Population: All treated participants with vital signs measurements

Outcome measures

Measure	Crohn's Disease n=24 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Number of Participants With Vital Signs Abnormalities HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM IM011077 STUDY BASELINE > 30	1 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -15	1 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM IM011077 STUDY BASELINE > 20	3 Participants	5 Participants
Number of Participants With Vital Signs Abnormalities SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM IM011077 STUDY BASELINE < -20	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM IM011077 STUDY BASELINE > 10	3 Participants	5 Participants
Number of Participants With Vital Signs Abnormalities DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -10	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 108

Population: All treated participants with baseline and post baseline measurements at pre-specified time points

Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function

Outcome measures

Measure	Crohn's Disease n=23 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=38 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Change From Baseline in Laboratory Parameters Cholesterol, Fasting Week 12	10.20 mg/dL Standard Error 7.207	-9.17 mg/dL Standard Error 4.629
Change From Baseline in Laboratory Parameters Cholesterol, Fasting Week 108	-12.00 mg/dL Standard Error NA insufficient number of participants with events	—
Change From Baseline in Laboratory Parameters HDL Cholesterol, Fasting Week 12	-0.75 mg/dL Standard Error 3.400	-0.83 mg/dL Standard Error 2.626
Change From Baseline in Laboratory Parameters HDL Cholesterol, Fasting Week 108	0.00 mg/dL Standard Error NA insufficient number of participants with events	—
Change From Baseline in Laboratory Parameters LDL Cholesterol, Fasting Week 12	4.75 mg/dL Standard Error 4.270	-6.50 mg/dL Standard Error 4.689
Change From Baseline in Laboratory Parameters LDL Cholesterol, Fasting Week 108	1.00 mg/dL Standard Error NA insufficient number of participants with events	—
Change From Baseline in Laboratory Parameters Triglycerides, Fasting Week 12	2.3 mg/dL Standard Error 11.31	3.2 mg/dL Standard Error 4.78
Change From Baseline in Laboratory Parameters Triglycerides, Fasting Week 108	-62.0 mg/dL Standard Error NA insufficient number of participants with events	—
Change From Baseline in Laboratory Parameters Bilirubin, Week 12	0.0650 mg/dL Standard Error 0.05028	0.0043 mg/dL Standard Error 0.03566
Change From Baseline in Laboratory Parameters Bilirubin, Week 108	-0.1000 mg/dL Standard Error 0.00000	—
Change From Baseline in Laboratory Parameters Glucose, Fasting Serum Week 12	1.75 mg/dL Standard Error 0.946	0.80 mg/dL Standard Error 1.114
Change From Baseline in Laboratory Parameters Glucose, Fasting Serum Week 108	29.00 mg/dL Standard Error NA insufficient number of participants with events	—
Change From Baseline in Laboratory Parameters Creatinine, Week 12	-0.008 mg/dL Standard Error 0.0182	0.004 mg/dL Standard Error 0.0153
Change From Baseline in Laboratory Parameters Phosphate, Week 12	0.153 mg/dL Standard Error 0.0893	0.019 mg/dL Standard Error 0.1198
Change From Baseline in Laboratory Parameters Phosphate, Week 108	-0.150 mg/dL Standard Error 0.1500	—
Change From Baseline in Laboratory Parameters Urea Nitrogen, Week 12	-0.269 mg/dL Standard Error 1.0631	0.511 mg/dL Standard Error 0.5902
Change From Baseline in Laboratory Parameters Urea Nitrogen, Week 108	5.500 mg/dL Standard Error 0.5000	—
Change From Baseline in Laboratory Parameters Calcium, Week 12	0.152 mg/dL Standard Error 0.0915	0.041 mg/dL Standard Error 0.0612
Change From Baseline in Laboratory Parameters Calcium, Week 108	0.350 mg/dL Standard Error 0.1500	—
Change From Baseline in Laboratory Parameters Creatinine, Week 108	0.080 mg/dL Standard Error 0.0100	—

PRIMARY outcome

Timeframe: Baseline, Week 48, Week 96

Population: All treated participants with baseline and post baseline measurements at pre-specified time points

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate

Outcome measures

Measure	Crohn's Disease n=9 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=17 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate ECG Mean Heart Rate, Week 48	-1.4 beats/min Standard Deviation 9.21	2.6 beats/min Standard Deviation 12.76
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate ECG Mean Heart Rate, Week 96	-1.0 beats/min Standard Deviation 11.27	-1.0 beats/min Standard Deviation NA insufficient number of participants with events

PRIMARY outcome

Timeframe: Baseline, Week 48, Week 96

Population: All treated participants with baseline and post baseline measurements at pre-specified time points

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters

Outcome measures

Measure	Crohn's Disease n=9 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=16 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, Aggregate, Week 48	9.1 msec Standard Deviation 20.62	-2.4 msec Standard Deviation 22.65
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, Aggregate, Week 96	14.7 msec Standard Deviation 16.56	-22.0 msec Standard Deviation NA insufficient number of participants with events
Change From Baseline in Electrocardiogram (ECG) Parameters QRS Duration, Aggregate, Week 48	-1.2 msec Standard Deviation 8.47	-0.9 msec Standard Deviation 8.53
Change From Baseline in Electrocardiogram (ECG) Parameters QRS Duration, Aggregate, Week 96	-9.3 msec Standard Deviation 2.89	0.0 msec Standard Deviation NA insufficient number of participants with events
Change From Baseline in Electrocardiogram (ECG) Parameters QT Interval, Aggregate, Week 48	18.6 msec Standard Deviation 30.33	7.6 msec Standard Deviation 40.35
Change From Baseline in Electrocardiogram (ECG) Parameters QTcF Interval, Aggregate, Week 48	-20.6388 msec Standard Deviation 197.49472	31.1621 msec Standard Deviation 141.14597
Change From Baseline in Electrocardiogram (ECG) Parameters QTcF Interval, Aggregate, Week 96	-86.9797 msec Standard Deviation 198.61888	101.0000 msec Standard Deviation NA insufficient number of participants with events
Change From Baseline in Electrocardiogram (ECG) Parameters QT Interval, Aggregate, Week 96	27.0 msec Standard Deviation 62.55	96.0 msec Standard Deviation NA insufficient number of participants with events
Change From Baseline in Electrocardiogram (ECG) Parameters QTcB Interval, Aggregate, Week 48	-2.3 msec Standard Deviation 21.78	7.7 msec Standard Deviation 19.41

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 108

Population: All treated participants with baseline and post baseline measurements at pre-specified time points

Changes from IM011077 study baseline in vital signs parameters - heart rate

Outcome measures

Measure	Crohn's Disease n=24 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Change From Baseline in Vital Signs Parameters - Heart Rate Heart Rate Week 12	3.6 beats/min Standard Deviation 11.89	0.9 beats/min Standard Deviation 10.71
Change From Baseline in Vital Signs Parameters - Heart Rate Heart Rate Week 108	1.0 beats/min Standard Deviation NA insufficient number of participants with events	—

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 108

Population: All treated participants with baseline and post baseline measurements at pre-specified time points

Changes from IM011077 study baseline in vital signs parameters

Outcome measures

Measure	Crohn's Disease n=24 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	Ulcerative Colitis n=41 Participants Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Change From Baseline in Vital Signs Parameters Systolic Blood Pressure Week 12	3.8 mmHg Standard Deviation 11.56	3.8 mmHg Standard Deviation 13.62
Change From Baseline in Vital Signs Parameters Systolic Blood Pressure Week 108	4.0 mmHg Standard Deviation NA insufficient number of participants with events	—
Change From Baseline in Vital Signs Parameters Diastolic Blood Pressure Week 12	0.3 mmHg Standard Deviation 7.82	-1.3 mmHg Standard Deviation 7.38
Change From Baseline in Vital Signs Parameters Diastolic Blood Pressure Week 108	9.0 mmHg Standard Deviation NA insufficient number of participants with events	—

Adverse Events

CROHN'S DISEASE

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

ULCERATIVE COLITIS

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	CROHN'S DISEASE n=24 participants at risk Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	ULCERATIVE COLITIS n=41 participants at risk Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Cardiac disorders Cardiac failure chronic	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	4.2% 1/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders General physical health deterioration	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	4.2% 1/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	4.2% 1/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	4.2% 1/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events

Measure	CROHN'S DISEASE n=24 participants at risk Deucravacitinib (BMS-986165) 6 mg twice daily (BID)	ULCERATIVE COLITIS n=41 participants at risk Deucravacitinib (BMS-986165) 6 mg twice daily (BID)
Gastrointestinal disorders Colitis ulcerative	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.3% 3/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth ulceration	8.3% 2/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	8.3% 2/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations COVID-19	25.0% 6/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.3% 3/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	12.5% 3/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	12.5% 3/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Tonsillitis	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.3% 3/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	8.3% 2/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.2% 5/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Depression	0.00% 0/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.3% 3/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.4% 1/41 • SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.com

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.
• Publication restrictions are in place

Restriction type: OTHER