Trial Outcomes & Findings for Open-label Extension Study of Brazikumab in Ulcerative Colitis (NCT NCT04277546)
NCT ID: NCT04277546
Last Updated: 2026-06-23
Results Overview
Number and percentage of patients with reported adverse events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Through Week 70
Results posted on
2026-06-23
Participant Flow
Participants were enrolled from study D5272C00001. Participants fulfilling response criteria specified in the protocol entered directly into the Maintenance period. Participants not fulfilling response criteria entered the Induction period, and then could continue into maintenance.
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 (D5272C00001).
|
Placebo/Brazikumab
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Period: Overall Study
STARTED
|
31
|
24
|
2
|
|
Period: Overall Study
COMPLETED
|
10
|
3
|
2
|
|
Period: Overall Study
NOT COMPLETED
|
21
|
21
|
0
|
|
Induction Period
STARTED
|
19
|
23
|
1
|
|
Induction Period
COMPLETED
|
10
|
14
|
1
|
|
Induction Period
NOT COMPLETED
|
9
|
9
|
0
|
|
Maintenance Period
STARTED
|
22
|
15
|
2
|
|
Maintenance Period
COMPLETED
|
10
|
3
|
2
|
|
Maintenance Period
NOT COMPLETED
|
12
|
12
|
0
|
Reasons for withdrawal
| Measure |
Brazikumab/Brazikumab
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Period: Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
|
Period: Overall Study
Reason Other as per CRF
|
7
|
7
|
0
|
|
Period: Overall Study
Study terminated by Sponsor
|
11
|
10
|
0
|
|
Period: Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Period: Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
|
Induction Period
Lack of Efficacy
|
2
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
0
|
2
|
0
|
|
Induction Period
Reason Other as per CRF.
|
7
|
7
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
1
|
1
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Maintenance Period
Study terminated by sponsor
|
11
|
10
|
0
|
Baseline Characteristics
Open-label Extension Study of Brazikumab in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Brazikumab/Brazikumab
n=31 Participants
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 Participants
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 Participants
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 15.84 • n=20 Participants
|
42.1 years
STANDARD_DEVIATION 14.18 • n=20 Participants
|
38.5 years
STANDARD_DEVIATION 13.44 • n=40 Participants
|
42.9 years
STANDARD_DEVIATION 15.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 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=31 Participants
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 Participants
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 Participants
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Adverse Events
|
15 Participants
|
11 Participants
|
2 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.
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=29 Participants
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=22 Participants
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 Participants
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Laboratory Values
Specific Gravity (RATIO) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Normal
|
28 Participants
|
22 Participants
|
2 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Low
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Normal
|
26 Participants
|
16 Participants
|
2 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Normal
|
29 Participants
|
21 Participants
|
2 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Normal
|
28 Participants
|
22 Participants
|
2 Participants
|
|
Laboratory Values
Albumin (g/L) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · Normal
|
29 Participants
|
21 Participants
|
2 Participants
|
|
Laboratory Values
Aspartate Aminotransferase (ukat/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urate (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urate (umol/L) · Normal
|
28 Participants
|
21 Participants
|
2 Participants
|
|
Laboratory Values
Urate (umol/L) · High
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Normal
|
23 Participants
|
20 Participants
|
2 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · High
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Normal
|
24 Participants
|
20 Participants
|
2 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · High
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Normal
|
22 Participants
|
21 Participants
|
2 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · High
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Normal
|
24 Participants
|
20 Participants
|
2 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Specific Gravity (RATIO) · Normal
|
20 Participants
|
17 Participants
|
1 Participants
|
|
Laboratory Values
Specific Gravity (RATIO) · High
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Normal
|
19 Participants
|
16 Participants
|
0 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · 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.
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=31 Participants
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 Participants
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 Participants
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · High
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Normal
|
28 Participants
|
21 Participants
|
2 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · High
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Normal
|
29 Participants
|
20 Participants
|
2 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · High
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Low
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Normal
|
24 Participants
|
19 Participants
|
2 Participants
|
|
Vital Signs
Weight (kg) · High
|
12 Participants
|
7 Participants
|
1 Participants
|
|
Vital Signs
Weight (kg) · Low
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Vital Signs
Weight (kg) · Normal
|
14 Participants
|
13 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.
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings.
Outcome measures
| Measure |
Brazikumab/Brazikumab
n=25 Participants
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 Participants
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 Participants
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
ECG
|
3 Participants
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through Week 70Population: Any new or aggravated clinically relevant abnormal medical finding occurring at a physical examination (PE) as compared with the Baseline assessment was considered as a treatment emergent adverse event and is reported in the Adverse Event section. No data related to the PE was captured and it was not captured for the adverse events if it was related to a PE. Since it was never collected it is not possible to report either any PE data or the AEs related to a PE separately.
Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).
Outcome measures
Outcome data not reported
Adverse Events
Brazikumab/Brazikumab
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo/Brazikumab
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Vedolizumab/Brazikumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brazikumab/Brazikumab
n=31 participants at risk
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 participants at risk
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 participants at risk
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • 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%
0/24 • 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=31 participants at risk
Participants who received brazikumab study intervention in the lead-in study (D5272C00001).
|
Placebo/Brazikumab
n=24 participants at risk
Participants who received placebo study intervention in the lead-in study (D5272C00001).
|
Vedolizumab/Brazikumab
n=2 participants at risk
Participants who received vedolizumab study intervention in the lead-in study (D5272C00001).
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • 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%
0/24 • 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
Folate deficiency
|
3.2%
1/31 • 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%
0/24 • 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
Iron deficiency
|
3.2%
1/31 • 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%
0/24 • 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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Headache
|
6.5%
2/31 • 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%
0/24 • 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
Taste disorder
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • 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%
0/24 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Colitis ulcerative
|
3.2%
1/31 • 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%
0/24 • 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
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Dry mouth
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Gastrooesophageal reflux disease
|
3.2%
1/31 • 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%
0/24 • 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
Haemorrhoids thrombosed
|
3.2%
1/31 • 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%
0/24 • 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
|
3.2%
1/31 • 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%
0/24 • 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
Rectal haemorrage
|
3.2%
1/31 • 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.
|
4.2%
1/24 • 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
Vomiting
|
3.2%
1/31 • 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%
0/24 • 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.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Acne
|
3.2%
1/31 • 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%
0/24 • 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
Dermatitis
|
3.2%
1/31 • 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%
0/24 • 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
Erythema
|
3.2%
1/31 • 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%
0/24 • 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
Pruritus
|
3.2%
1/31 • 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.
|
4.2%
1/24 • 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
Rash
|
3.2%
1/31 • 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%
0/24 • 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 irritation
|
3.2%
1/31 • 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%
0/24 • 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
|
3.2%
1/31 • 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%
0/24 • 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
Urticaria
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Arthralgia
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Rheumatoid arthritis
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Nephrolithiasis
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Asthenia
|
3.2%
1/31 • 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%
0/24 • 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
|
3.2%
1/31 • 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%
0/24 • 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
Injection site erythema
|
6.5%
2/31 • 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%
0/24 • 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
Injection site pain
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Injection site pruritus
|
9.7%
3/31 • 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%
0/24 • 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
Injection site swelling
|
6.5%
2/31 • 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%
0/24 • 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
Injection site urticaria
|
3.2%
1/31 • 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%
0/24 • 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
Malaise
|
3.2%
1/31 • 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%
0/24 • 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
Weight increased
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Post-traumatic pain
|
3.2%
1/31 • 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%
0/24 • 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.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/31 • 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%
0/24 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • 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.
|
12.5%
3/24 • 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
Oral candidiasis
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Sinusitis
|
3.2%
1/31 • 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.
|
4.2%
1/24 • 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
Tooth infection
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
Upper respiratory tract infection
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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
|
3.2%
1/31 • 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%
0/24 • 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
|
12.9%
4/31 • 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%
0/24 • 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
Candida infection
|
3.2%
1/31 • 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%
0/24 • 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
Ear infection
|
3.2%
1/31 • 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%
0/24 • 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
Fungal foot infection
|
3.2%
1/31 • 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%
0/24 • 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
|
0.00%
0/31 • 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.
|
4.2%
1/24 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place