Trial Outcomes & Findings for Open-label Extension Study of Brazikumab in Crohn's Disease (NCT NCT03961815)
NCT ID: NCT03961815
Last Updated: 2026-04-01
Results Overview
Number and percentage of patients with Potentially Clinically Significant results in systolic and diastolic blood pressure, pulse rate and weight.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
through Week 70
Results posted on
2026-04-01
Participant Flow
Two subjects were assigned treatment but were also defined as screen failures based on Protocol Section 5.4. These patients never received treatment and are not included in the Participant Flow.
As of 1 June 2023, AstraZeneca discontinued the development of brazikumab. All study related dosing was immediately stopped. Because of study early termination, site data cleaning engagement proved challenging and as a result databases were locked with unclean data. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). Please be aware that the data submitted needs to be considered with the data quality in mind.
Participant milestones
| Measure |
Brazikumab/Brazikumab
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
2
|
|
Overall Study
COMPLETED
|
5
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
0
|
Reasons for withdrawal
| Measure |
Brazikumab/Brazikumab
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
The reason is either study terminated by the Sponsor, or Unknown.
|
3
|
3
|
0
|
Baseline Characteristics
Open-label Extension Study of Brazikumab in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Brazikumab/Brazikumab
n=12 Participants
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 Participants
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 Participants
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age, continuous
|
45.3 years
STANDARD_DEVIATION 15.74 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 17.84 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 6.36 • n=10 Participants
|
44.7 years
STANDARD_DEVIATION 15.70 • n=16 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
11 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Through Week 70Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
Number and percentage of patients with reported adverse events
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=12 Participants
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 Participants
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 Participants
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Adverse Events
Any adverse event
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events
No adverse events noted
|
1 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: through Week 70Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study. Participants with a baseline value and at least one post-baseline value are included in the analysis.
Number and percentage of patients with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, urinalysis.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=11 Participants
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 Participants
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 Participants
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Laboratory Values
Hemoglobin (g/L) · Normal
|
9 Participants
|
4 Participants
|
1 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Low
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Normal
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Normal
|
10 Participants
|
3 Participants
|
2 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Low
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · Normal
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Laboratory Values
Neutrophils (10^9/L) · Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · High
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Normal
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Albumin (g/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · High
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · Normal
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Bilirubin (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Calcium (mmol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Calcium (mmol/L) · Normal
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Calcium (mmol/L) · Low
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Creatinine (umol/L) · High
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Creatinine (umol/L) · Normal
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Creatinine (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Glucose (mmol/L) · High
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Normal
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Low
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · Normal
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · Low
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Potassium (mmol/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Potassium (mmol/L) · Normal
|
11 Participants
|
3 Participants
|
2 Participants
|
|
Laboratory Values
Potassium (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · High
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · Normal
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Laboratory Values
Protein (g/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urate (umol/L) · High
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Laboratory Values
Urate (umol/L) · Normal
|
9 Participants
|
1 Participants
|
1 Participants
|
|
Laboratory Values
Urate (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Normal
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · High
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Normal
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Normal
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · High
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Normal
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · Normal
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Laboratory Values
Eosinophils/Leukocytes (%) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Normal
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Low
|
4 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: through Week 70Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study. Participants with a baseline value and at least one post-baseline value are included in the analysis.
Number and percentage of patients with Potentially Clinically Significant results in systolic and diastolic blood pressure, pulse rate and weight.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=12 Participants
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 Participants
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 Participants
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · High
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Normal
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · High
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Normal
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Low
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · High
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Normal
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Low
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Weight (kg) · High
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Vital Signs
Weight (kg) · Normal
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Vital Signs
Weight (kg) · Low
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: through Week 70Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study. Participants with a baseline value and at least one post-baseline value are included in the analysis.
Number and percentage of patients with Potentially Clinically Significant results in 12-lead ECG recordings.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=12 Participants
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 Participants
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 Participants
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
ECG
Abnormal
|
2 Participants
|
0 Participants
|
0 Participants
|
|
ECG
Normal
|
7 Participants
|
4 Participants
|
2 Participants
|
|
ECG
No data
|
3 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Brazikumab/Brazikumab
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo/Brazikumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Adalimumab/Brazikumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brazikumab/Brazikumab
n=12 participants at risk
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 participants at risk
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 participants at risk
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Infections and infestations
Peritonitis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Ileal stenosis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
Other adverse events
| Measure |
Brazikumab/Brazikumab
n=12 participants at risk
Participants who received brazikumab study intervention in the lead-in study (D5271C00001).
|
Placebo/Brazikumab
n=4 participants at risk
Participants who received placebo study intervention in the lead-in study (D5271C00001).
|
Adalimumab/Brazikumab
n=2 participants at risk
Participants who received adalimumab study intervention in the lead-in study (D5271C00001).
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
COVID-19 pneumonia
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Clostridium difficile infection
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Kidney infection
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Peritonitis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Ileal stenosis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Loin pain haematuria syndrome
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
25.0%
1/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Urethral stenosis
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Reproductive system and breast disorders
Scrotal cyst
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Pain
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Investigations
Interferon gamma release assay positive
|
0.00%
0/12 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/4 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 70
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place