Trial Outcomes & Findings for Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy (NCT NCT01490450)
NCT ID: NCT01490450
Last Updated: 2021-11-05
Results Overview
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
COMPLETED
PHASE2
165 participants
At 16 weeks
2021-11-05
Participant Flow
Participant milestones
| Measure |
Placebo
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Period 1
STARTED
|
41
|
41
|
42
|
41
|
|
Period 1
COMPLETED
|
38
|
40
|
38
|
33
|
|
Period 1
NOT COMPLETED
|
3
|
1
|
4
|
8
|
|
Period 2
STARTED
|
38
|
40
|
37
|
32
|
|
Period 2
COMPLETED
|
36
|
39
|
37
|
28
|
|
Period 2
NOT COMPLETED
|
2
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Period 1
Lack of Efficacy
|
2
|
0
|
3
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
5
|
|
Period 1
Request to discontinue treatment
|
1
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
|
Period 1
No longer met study criteria
|
0
|
1
|
1
|
0
|
|
Period 2
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
1
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
152 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 10.53 • n=93 Participants
|
49.8 years
STANDARD_DEVIATION 14.05 • n=4 Participants
|
49.3 years
STANDARD_DEVIATION 10.84 • n=27 Participants
|
44.7 years
STANDARD_DEVIATION 13.75 • n=483 Participants
|
47.9 years
STANDARD_DEVIATION 12.43 • n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
79 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: At 16 weeksPopulation: Modified Intent-to-Treat (MITT) defined as all randomized subjects that received at least one dose of the study medication.
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
|
29.3 percentage of participants
|
46.3 percentage of participants
|
52.4 percentage of participants
|
39.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 24Population: MITT
To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques. These grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72. PASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
week 16
|
14.6 percentage of participants
|
12.2 percentage of participants
|
16.7 percentage of participants
|
4.9 percentage of participants
|
|
Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
week 24
|
12.2 percentage of participants
|
19.5 percentage of participants
|
28.6 percentage of participants
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 24Population: MITT
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Percent of Participants Achieving ACR50 and ACR70 Response Rate
ACR50 (16 weeks)
|
7.3 percentage of participants
|
29.3 percentage of participants
|
35.7 percentage of participants
|
17.1 percentage of participants
|
|
Percent of Participants Achieving ACR50 and ACR70 Response Rate
ACR50 (24 weeks)
|
14.6 percentage of participants
|
34.1 percentage of participants
|
35.7 percentage of participants
|
24.4 percentage of participants
|
|
Percent of Participants Achieving ACR50 and ACR70 Response Rate
ACR70 (16 weeks)
|
2.4 percentage of participants
|
17.1 percentage of participants
|
14.3 percentage of participants
|
4.9 percentage of participants
|
|
Percent of Participants Achieving ACR50 and ACR70 Response Rate
ACR70 (24 weeks)
|
4.9 percentage of participants
|
19.5 percentage of participants
|
23.8 percentage of participants
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: MITT
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Percent of Participants Achieving ACR20 Response Rate at Week 24
|
34.1 percentage of participants
|
56.1 percentage of participants
|
57.1 percentage of participants
|
39.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 16 and Week 24Population: MITT
For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). Response is measured by a reduction of at least 0.3 unit from baseline in HAQ index.
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
week 16
|
36.6 percentage of participants
|
48.8 percentage of participants
|
45.2 percentage of participants
|
39.0 percentage of participants
|
|
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
week 24
|
26.8 percentage of participants
|
51.2 percentage of participants
|
47.6 percentage of participants
|
36.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: MITT
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Outcome measures
| Measure |
Placebo
n=40 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=40 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=41 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=39 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
Mental component
|
1.4 score on a scale
Standard Error 1.507
|
1.2 score on a scale
Standard Error 1.502
|
3.7 score on a scale
Standard Error 1.478
|
1.1 score on a scale
Standard Error 1.516
|
|
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
Physical component
|
4.4 score on a scale
Standard Error 1.236
|
6.5 score on a scale
Standard Error 1.236
|
4.6 score on a scale
Standard Error 1.217
|
4.1 score on a scale
Standard Error 1.248
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: MITT
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Outcome measures
| Measure |
Placebo
n=31 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=38 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=36 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=28 Participants
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline at Week 24 in SF-36 Scores
Mental component
|
3.6 score on a scale
Standard Error 1.646
|
1.4 score on a scale
Standard Error 1.538
|
3.9 score on a scale
Standard Error 1.548
|
2.1 score on a scale
Standard Error 1.689
|
|
Mean Change From Baseline at Week 24 in SF-36 Scores
Physical component
|
4.9 score on a scale
Standard Error 1.420
|
8.2 score on a scale
Standard Error 1.360
|
5.7 score on a scale
Standard Error 1.363
|
6.4 score on a scale
Standard Error 1.461
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: MITT
Outcome measures
| Measure |
Placebo
n=41 Participants
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=42 Participants
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=41 Participants
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Number of Participants With Anti-clazakizumab Antibodies
|
1 participants
|
0 participants
|
1 participants
|
—
|
Adverse Events
Placebo
Clazakizumab (25mg)
Clazakizumab (100mg)
Clazakizumab (200mg)
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 participants at risk
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 participants at risk
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 participants at risk
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Dystonia
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Cardiac disorders
Adute myocardial infarction
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
General disorders
Chest pain
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Subcutaneous, every 4 weeks for 24 weeks
|
Clazakizumab (25mg)
n=41 participants at risk
Subcutaneous, 25 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (100mg)
n=42 participants at risk
Subcutaneous, 100 mg, every 4 weeks, for 24 weeks
|
Clazakizumab (200mg)
n=41 participants at risk
Subcutaneous, 200 mg, every 4 weeks, for 24 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Up to 24 weeks per participant
|
14.6%
6/41 • Up to 24 weeks per participant
|
4.8%
2/42 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
|
Infections and infestations
Pharyngitis
|
9.8%
4/41 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Infections and infestations
Upper respiratory tract infection
|
14.6%
6/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
7.1%
3/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Infections and infestations
Bronchitis
|
4.9%
2/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
7.1%
3/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41 • Up to 24 weeks per participant
|
22.0%
9/41 • Up to 24 weeks per participant
|
14.3%
6/42 • Up to 24 weeks per participant
|
19.5%
8/41 • Up to 24 weeks per participant
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Up to 24 weeks per participant
|
14.6%
6/41 • Up to 24 weeks per participant
|
9.5%
4/42 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
7.3%
3/41 • Up to 24 weeks per participant
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/41 • Up to 24 weeks per participant
|
12.2%
5/41 • Up to 24 weeks per participant
|
4.8%
2/42 • Up to 24 weeks per participant
|
12.2%
5/41 • Up to 24 weeks per participant
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
7.1%
3/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
2/41 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
7.3%
3/41 • Up to 24 weeks per participant
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
General disorders
Injection site reaction
|
2.4%
1/41 • Up to 24 weeks per participant
|
9.8%
4/41 • Up to 24 weeks per participant
|
2.4%
1/42 • Up to 24 weeks per participant
|
4.9%
2/41 • Up to 24 weeks per participant
|
|
General disorders
Injection site erythema
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
7.1%
3/42 • Up to 24 weeks per participant
|
7.3%
3/41 • Up to 24 weeks per participant
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • Up to 24 weeks per participant
|
7.3%
3/41 • Up to 24 weeks per participant
|
4.8%
2/42 • Up to 24 weeks per participant
|
2.4%
1/41 • Up to 24 weeks per participant
|
|
Nervous system disorders
Migraine
|
7.3%
3/41 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
0.00%
0/42 • Up to 24 weeks per participant
|
0.00%
0/41 • Up to 24 weeks per participant
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Up to 24 weeks per participant
|
4.9%
2/41 • Up to 24 weeks per participant
|
4.8%
2/42 • Up to 24 weeks per participant
|
12.2%
5/41 • Up to 24 weeks per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place