Trial Outcomes & Findings for Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease (NCT NCT01545050)
NCT ID: NCT01545050
Last Updated: 2021-12-03
Results Overview
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
At 8 weeks during the Induction Period
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
9
|
18
|
18
|
|
Overall Study
COMPLETED
|
11
|
4
|
4
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
5
|
12
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
2
|
0
|
|
Overall Study
Discontinued study treatment
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Participant no longer meets study criteria
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Administrative reason by sponsor
|
4
|
2
|
3
|
5
|
5
|
Baseline Characteristics
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 Participants
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=9 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=18 Participants
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=18 Participants
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 14.79 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 17.29 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 10.96 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 11.48 • n=21 Participants
|
38.6 years
STANDARD_DEVIATION 12.53 • n=8 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At 8 weeks during the Induction PeriodPopulation: modified Intent-to-Treat (mITT) defined as all randomized and treated subjects who had a chance to reach Day 57 by the date of study termination
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Outcome measures
| Measure |
Placebo
n=17 Participants
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 Participants
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=8 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=16 Participants
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=16 Participants
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Percent of Participants With Clinical Remission (CDAI<150) as Measured by the Crohn's Disease Activity Index (CDAI)
|
17.6 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
18.8 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: At 8 weeks during the Induction PeriodPopulation: mITT
CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. A decrease in greater than 100 points indicates a clinically significant improvement in disease activity
Outcome measures
| Measure |
Placebo
n=17 Participants
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 Participants
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=8 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=16 Participants
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=16 Participants
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Percent of Participants With Clinical Response (>100 Point Decrease in CDAI) During Induction Period as Measured by CDAI
|
29.4 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
31.3 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: mITT
IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Outcome measures
| Measure |
Placebo
n=16 Participants
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=8 Participants
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=8 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=15 Participants
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=13 Participants
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Week 8
|
11.8 score on a scale
Standard Deviation 23.01
|
-2.0 score on a scale
Standard Deviation 28.93
|
1.9 score on a scale
Standard Deviation 36.46
|
15.5 score on a scale
Standard Deviation 32.01
|
14.8 score on a scale
Standard Deviation 33.7
|
|
Change From Baseline at Week 8 and 12 of Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Week 12
|
10.0 score on a scale
Standard Deviation 33.65
|
21.8 score on a scale
Standard Deviation 34.62
|
1.4 score on a scale
Standard Deviation 61.06
|
20.1 score on a scale
Standard Deviation 36.32
|
18.7 score on a scale
Standard Deviation 35.62
|
SECONDARY outcome
Timeframe: Up to Week 12Population: mITT
Outcome measures
| Measure |
Placebo
n=17 Participants
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 Participants
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=9 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=17 Participants
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=16 Participants
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Number of Participants During the Induction Period With Anti-clazakizumab Antibodies
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8Population: Due to early termination of the study, only a limited number of PK samples were collected and analyzed.
Outcome measures
| Measure |
Placebo
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=18 Participants
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Week 4
|
—
|
—
|
21.0816 ug/mL
Standard Deviation 8.19326
|
—
|
—
|
|
Steady-state Trough Concentration (Cmin) of Clazakizumab During the Induction Period
Week 8
|
—
|
—
|
36.1026 ug/mL
Standard Deviation 14.49349
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 4Population: The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 4, Week 8Population: The interpretation of the PK analysis is limited for several reasons. First, the concentration data that was collected only allowed for reporting of Cmin concentrations. Second, the sample size was limited.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Clazakizumab (150 IV/100 SC)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Clazakizumab (300 IV/100 SC)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Clazakizumab (400 SC/200 SC)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Clazakizumab (600 IV/200 SC)
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 participants at risk
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=9 participants at risk
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=18 participants at risk
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=18 participants at risk
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Cronh's disease
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
2/18 • Up to 12 weeks per participant
|
16.7%
3/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Anal fistula
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Peritonitis
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Anal fistula infection
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Erysipelas
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Septic shock
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
General physical health deterioration
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks
|
Clazakizumab (150 IV/100 SC)
n=9 participants at risk
IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (300 IV/100 SC)
n=9 participants at risk
IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day
|
Clazakizumab (400 SC/200 SC)
n=18 participants at risk
SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day
|
Clazakizumab (600 IV/200 SC)
n=18 participants at risk
IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day
|
|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
2/18 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
|
General disorders
Injection site reaction
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
2/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Chest pain
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Chills
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Injection site haematoma
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Injection site induration
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Injection site rash
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Erysipelas
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Peritonitis
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Septic shock
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Skin infection
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Nervous system disorders
Insomnia
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Eye disorders
Dry eye
|
0.00%
0/18 • Up to 12 weeks per participant
|
11.1%
1/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
|
Investigations
Blood albumin decreased
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Investigations
Monocyte count increased
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Investigations
Neutrophil count increased
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
|
Investigations
Protein total decreased
|
0.00%
0/18 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
0.00%
0/9 • Up to 12 weeks per participant
|
5.6%
1/18 • Up to 12 weeks per participant
|
0.00%
0/18 • Up to 12 weeks per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place