Crohn Disease, Ulcerative Colitis
Conditions
Keywords
BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
Exclusion criteria
* Women who are pregnant or breastfeeding * Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From first dose to 30 days post last dose (Up to 110 weeks) | 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 |
| Number of Participants With Laboratory Abnormalities | From first dose to 30 days post last dose (Up to 110 weeks) | Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | From first dose to 30 days post last dose (Up to 110 weeks) | — |
| Number of Participants With Vital Signs Abnormalities | From first dose to 30 days post last dose (Up to 110 weeks) | — |
| Change From Baseline in Laboratory Parameters | Baseline, Week 12, Week 108 | Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function |
| Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate | Baseline, Week 48, Week 96 | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline, Week 48, Week 96 | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters |
| Change From Baseline in Vital Signs Parameters - Heart Rate | Baseline, Week 12, Week 108 | Changes from IM011077 study baseline in vital signs parameters - heart rate |
| Change From Baseline in Vital Signs Parameters | Baseline, Week 12, Week 108 | Changes from IM011077 study baseline in vital signs parameters |
Countries
Australia, Canada, China, Germany, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Romania, Russia, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crohn's Disease Deucravacitinib (BMS-986165) 6 mg twice daily (BID) | 26 |
| Ulcerative Colitis Deucravacitinib (BMS-986165) 6 mg twice daily (BID) | 41 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment | Administrative reasons by sponsor | 17 | 33 |
| Treatment | Adverse Event | 2 | 1 |
| Treatment | Other reasons | 3 | 1 |
| Treatment | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Crohn's Disease | Ulcerative Colitis | Total |
|---|---|---|---|
| Age, Continuous | 38.7 Years STANDARD_DEVIATION 14.08 | 44.3 Years STANDARD_DEVIATION 15.7 | 42.2 Years STANDARD_DEVIATION 15.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 35 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Chinese | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 38 Participants | 59 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 29 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 41 |
| other Total, other adverse events | 12 / 24 | 13 / 41 |
| serious Total, serious adverse events | 2 / 24 | 2 / 41 |
Outcome results
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Time frame: Baseline, Week 48, Week 96
Population: All treated participants with baseline and post baseline measurements at pre-specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Aggregate, Week 96 | -9.3 msec | Standard Deviation 2.89 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Aggregate, Week 48 | -20.6388 msec | Standard Deviation 197.49472 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Aggregate, Week 96 | 14.7 msec | Standard Deviation 16.56 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Aggregate, Week 96 | 27.0 msec | Standard Deviation 62.55 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Aggregate, Week 48 | -1.2 msec | Standard Deviation 8.47 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Aggregate, Week 48 | 18.6 msec | Standard Deviation 30.33 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, Aggregate, Week 48 | -2.3 msec | Standard Deviation 21.78 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Aggregate, Week 96 | -86.9797 msec | Standard Deviation 198.61888 |
| Crohn's Disease | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Aggregate, Week 48 | 9.1 msec | Standard Deviation 20.62 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Aggregate, Week 96 | 101.0000 msec | — |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Aggregate, Week 48 | -2.4 msec | Standard Deviation 22.65 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Aggregate, Week 96 | 0.0 msec | — |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Aggregate, Week 48 | 7.6 msec | Standard Deviation 40.35 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Aggregate, Week 96 | 96.0 msec | — |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, Aggregate, Week 48 | 7.7 msec | Standard Deviation 19.41 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Aggregate, Week 96 | -22.0 msec | — |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Aggregate, Week 48 | -0.9 msec | Standard Deviation 8.53 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Aggregate, Week 48 | 31.1621 msec | Standard Deviation 141.14597 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Time frame: Baseline, Week 48, Week 96
Population: All treated participants with baseline and post baseline measurements at pre-specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | 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 |
| Crohn's Disease | 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 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate | ECG Mean Heart Rate, Week 48 | 2.6 beats/min | Standard Deviation 12.76 |
| Ulcerative Colitis | Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate | ECG Mean Heart Rate, Week 96 | -1.0 beats/min | — |
Primary
Change From Baseline in Laboratory Parameters
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Time frame: Baseline, Week 12, Week 108
Population: All treated participants with baseline and post baseline measurements at pre-specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Change From Baseline in Laboratory Parameters | LDL Cholesterol, Fasting Week 12 | 4.75 mg/dL | Standard Error 4.27 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Cholesterol, Fasting Week 108 | -12.00 mg/dL | — |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | HDL Cholesterol, Fasting Week 12 | -0.75 mg/dL | Standard Error 3.4 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | HDL Cholesterol, Fasting Week 108 | 0.00 mg/dL | — |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Bilirubin, Week 12 | 0.0650 mg/dL | Standard Error 0.05028 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Glucose, Fasting Serum Week 108 | 29.00 mg/dL | — |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Calcium, Week 12 | 0.152 mg/dL | Standard Error 0.0915 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Calcium, Week 108 | 0.350 mg/dL | Standard Error 0.15 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Creatinine, Week 12 | -0.008 mg/dL | Standard Error 0.0182 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Creatinine, Week 108 | 0.080 mg/dL | Standard Error 0.01 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Phosphate, Week 12 | 0.153 mg/dL | Standard Error 0.0893 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | LDL Cholesterol, Fasting Week 108 | 1.00 mg/dL | — |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Triglycerides, Fasting Week 12 | 2.3 mg/dL | Standard Error 11.31 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Triglycerides, Fasting Week 108 | -62.0 mg/dL | — |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Bilirubin, Week 108 | -0.1000 mg/dL | Standard Error 0 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Glucose, Fasting Serum Week 12 | 1.75 mg/dL | Standard Error 0.946 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Phosphate, Week 108 | -0.150 mg/dL | Standard Error 0.15 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Urea Nitrogen, Week 12 | -0.269 mg/dL | Standard Error 1.0631 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Urea Nitrogen, Week 108 | 5.500 mg/dL | Standard Error 0.5 |
| Crohn's Disease | Change From Baseline in Laboratory Parameters | Cholesterol, Fasting Week 12 | 10.20 mg/dL | Standard Error 7.207 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | LDL Cholesterol, Fasting Week 12 | -6.50 mg/dL | Standard Error 4.689 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Urea Nitrogen, Week 12 | 0.511 mg/dL | Standard Error 0.5902 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Phosphate, Week 12 | 0.019 mg/dL | Standard Error 0.1198 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Triglycerides, Fasting Week 12 | 3.2 mg/dL | Standard Error 4.78 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Calcium, Week 12 | 0.041 mg/dL | Standard Error 0.0612 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Cholesterol, Fasting Week 12 | -9.17 mg/dL | Standard Error 4.629 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Bilirubin, Week 12 | 0.0043 mg/dL | Standard Error 0.03566 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Glucose, Fasting Serum Week 12 | 0.80 mg/dL | Standard Error 1.114 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | Creatinine, Week 12 | 0.004 mg/dL | Standard Error 0.0153 |
| Ulcerative Colitis | Change From Baseline in Laboratory Parameters | HDL Cholesterol, Fasting Week 12 | -0.83 mg/dL | Standard Error 2.626 |
Primary
Change From Baseline in Vital Signs Parameters
Changes from IM011077 study baseline in vital signs parameters
Time frame: Baseline, Week 12, Week 108
Population: All treated participants with baseline and post baseline measurements at pre-specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Change From Baseline in Vital Signs Parameters | Systolic Blood Pressure Week 12 | 3.8 mmHg | Standard Deviation 11.56 |
| Crohn's Disease | Change From Baseline in Vital Signs Parameters | Systolic Blood Pressure Week 108 | 4.0 mmHg | — |
| Crohn's Disease | Change From Baseline in Vital Signs Parameters | Diastolic Blood Pressure Week 12 | 0.3 mmHg | Standard Deviation 7.82 |
| Crohn's Disease | Change From Baseline in Vital Signs Parameters | Diastolic Blood Pressure Week 108 | 9.0 mmHg | — |
| Ulcerative Colitis | Change From Baseline in Vital Signs Parameters | Systolic Blood Pressure Week 12 | 3.8 mmHg | Standard Deviation 13.62 |
| Ulcerative Colitis | Change From Baseline in Vital Signs Parameters | Diastolic Blood Pressure Week 12 | -1.3 mmHg | Standard Deviation 7.38 |
Primary
Change From Baseline in Vital Signs Parameters - Heart Rate
Changes from IM011077 study baseline in vital signs parameters - heart rate
Time frame: Baseline, Week 12, Week 108
Population: All treated participants with baseline and post baseline measurements at pre-specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Change From Baseline in Vital Signs Parameters - Heart Rate | Heart Rate Week 12 | 3.6 beats/min | Standard Deviation 11.89 |
| Crohn's Disease | Change From Baseline in Vital Signs Parameters - Heart Rate | Heart Rate Week 108 | 1.0 beats/min | — |
| Ulcerative Colitis | Change From Baseline in Vital Signs Parameters - Heart Rate | Heart Rate Week 12 | 0.9 beats/min | Standard Deviation 10.71 |
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Population: All treated participants with ECG measurements
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) >= 500 | 0 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | CHANGE FROM IM011077 STUDY BASELINE > 60 MSEC | 3 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) 480 - < 500 | 0 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | PRAG (MSEC) P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC | 0 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | 30 < CHANGE FROM IM011077 STUDY BASELINE <= 60 MSEC | 3 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | QRSAG(MSEC) QRS INTERVAL >= 200 MSEC | 0 Participants |
| Crohn's Disease | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) 450 - < 480 | 1 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | QRSAG(MSEC) QRS INTERVAL >= 200 MSEC | 0 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) 450 - < 480 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) 480 - < 500 | 1 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | QTCF (MSEC) >= 500 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | 30 < CHANGE FROM IM011077 STUDY BASELINE <= 60 MSEC | 0 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | CHANGE FROM IM011077 STUDY BASELINE > 60 MSEC | 5 Participants |
| Ulcerative Colitis | Number of Participants With Electrocardiogram (ECG) Abnormalities | PRAG (MSEC) P WAVE AND R WAVE (PR) INTERVAL >= 240 MSEC | 0 Participants |
Primary
Number of Participants With Laboratory Abnormalities
Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Population: All treated participants with laboratory measurements
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Potassium < 3 or > 5.5 MEQ/L (MMOL/L) | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Creatine Kinase > 10xupper limit of normal | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Platelet Count < 75 x 10^9/L or > 999 x 10^9/L | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Hemoglobin < 7.0 G/DL or > 30% reduction from baseline | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Sodium < 130 or > 150 MEQ/L (MMOL/L) | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Hematocrit < 20% or 30% reduction from baseline | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | White Blood Cell Count < 1.5 x 10^9/L or > 35 x 10^9/L | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Serum Creatinine Increase > 50% and > 44.2 UMOL/L | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Lymphocyte Count < 0.5 x 10^9/L | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Albumin < 2.0 G/DL | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Neutrophil Count < 0.75 x 10^9/L | 0 Participants |
| Crohn's Disease | Number of Participants With Laboratory Abnormalities | Calcium > 12.5 MG/DL | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Neutrophil Count < 0.75 x 10^9/L | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Platelet Count < 75 x 10^9/L or > 999 x 10^9/L | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Serum Creatinine Increase > 50% and > 44.2 UMOL/L | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Sodium < 130 or > 150 MEQ/L (MMOL/L) | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Potassium < 3 or > 5.5 MEQ/L (MMOL/L) | 1 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Calcium > 12.5 MG/DL | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Fasting Serum Glucose < 50 MG/DL or > 250 MG/DL | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Albumin < 2.0 G/DL | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Creatine Kinase > 10xupper limit of normal | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Hemoglobin < 7.0 G/DL or > 30% reduction from baseline | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Hematocrit < 20% or 30% reduction from baseline | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | White Blood Cell Count < 1.5 x 10^9/L or > 35 x 10^9/L | 0 Participants |
| Ulcerative Colitis | Number of Participants With Laboratory Abnormalities | Lymphocyte Count < 0.5 x 10^9/L | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 18 Participants |
| Crohn's Disease | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | AEs of Interest - Creatine Kinase events | 2 Participants |
| Crohn's Disease | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 Participants |
| Crohn's Disease | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | AEs of Interest - Skin-related events | 0 Participants |
| Crohn's Disease | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs leading to study discontinuation | 1 Participants |
| Ulcerative Colitis | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | AEs of Interest - Skin-related events | 2 Participants |
| Ulcerative Colitis | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs leading to study discontinuation | 1 Participants |
| Ulcerative Colitis | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 Participants |
| Ulcerative Colitis | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | AEs of Interest - Creatine Kinase events | 3 Participants |
| Ulcerative Colitis | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 19 Participants |
Primary
Number of Participants With Vital Signs Abnormalities
Time frame: From first dose to 30 days post last dose (Up to 110 weeks)
Population: All treated participants with vital signs measurements
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM IM011077 STUDY BASELINE > 30 | 1 Participants |
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -15 | 1 Participants |
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM IM011077 STUDY BASELINE > 20 | 3 Participants |
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM IM011077 STUDY BASELINE < -20 | 0 Participants |
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM IM011077 STUDY BASELINE > 10 | 3 Participants |
| Crohn's Disease | Number of Participants With Vital Signs Abnormalities | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -10 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM IM011077 STUDY BASELINE > 10 | 5 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM IM011077 STUDY BASELINE > 30 | 1 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM IM011077 STUDY BASELINE < -20 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -15 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM IM011077 STUDY BASELINE < -10 | 0 Participants |
| Ulcerative Colitis | Number of Participants With Vital Signs Abnormalities | SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM IM011077 STUDY BASELINE > 20 | 5 Participants |