Trial Outcomes & Findings for A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris (NCT NCT03073213)
NCT ID: NCT03073213
Last Updated: 2020-07-22
Results Overview
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Results posted on
2020-07-22
Participant Flow
All the re-enrolled participants from single dose period (SDP) to multiple dose period (MDP) have been washed out and screened for eligibility to MDP.
Participant milestones
| Measure |
Ixekizumab Single Dose
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q2W Multiple Dose
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|---|
|
Single Dose Period
STARTED
|
12
|
0
|
0
|
|
Single Dose Period
COMPLETED
|
12
|
0
|
0
|
|
Single Dose Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Multiple Dose Period
STARTED
|
0
|
14
|
15
|
|
Multiple Dose Period
Participants Enrolled From Single Dose
|
0
|
7
|
2
|
|
Multiple Dose Period
COMPLETED
|
0
|
14
|
14
|
|
Multiple Dose Period
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ixekizumab Single Dose
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q2W Multiple Dose
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|---|
|
Multiple Dose Period
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
Baseline characteristics by cohort
| Measure |
Ixekizumab Single Dose
n=12 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q2W Multiple Dose
n=14 Participants
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
n=15 Participants
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Single Dose
|
49.0 years
STANDARD_DEVIATION 12.1 • n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
—
|
—
|
49.0 years
STANDARD_DEVIATION 12.1 • n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Age, Continuous
Multiple Dose
|
—
|
45.6 years
STANDARD_DEVIATION 12.5 • n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
45.5 years
STANDARD_DEVIATION 16.1 • n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
45.6 years
STANDARD_DEVIATION 14.2 • n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Sex: Female, Male
Single Dose · Female
|
2 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
2 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Sex: Female, Male
Single Dose · Male
|
10 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
10 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Sex: Female, Male
Multiple Dose · Female
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
3 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
5 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
8 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Sex: Female, Male
Multiple Dose · Male
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
11 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
10 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
21 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Single Dose Phase · Hispanic or Latino
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Single Dose Phase · Not Hispanic or Latino
|
12 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
12 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Single Dose Phase · Unknown or Not Reported
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Multiple Dose Phase · Hispanic or Latino
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Multiple Dose Phase · Not Hispanic or Latino
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
14 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
15 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
29 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Ethnicity (NIH/OMB)
Multiple Dose Phase · Unknown or Not Reported
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · American Indian or Alaska Native
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · Asian
|
12 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
12 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · Black or African American
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · White
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · More than one race
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Single Dose Phase · Unknown or Not Reported
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=12 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · American Indian or Alaska Native
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · Asian
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
14 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
15 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
29 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · Black or African American
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · White
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · More than one race
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Race (NIH/OMB)
Multiple Dose Phase · Unknown or Not Reported
|
0 Participants
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=14 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=15 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
0 Participants
n=29 Participants • All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
|
|
Region of Enrollment
China · Single Dose
|
12 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
12 Participants
n=41 Participants
|
|
Region of Enrollment
China · Multiple Dose
|
0 Participants
n=12 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
29 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141Population: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Outcome measures
| Measure |
Ixekizumab Single Dose
n=12 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
|
6.90 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 43
|
—
|
PRIMARY outcome
Timeframe: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141Population: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Outcome measures
| Measure |
Ixekizumab Single Dose
n=12 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
|
147 Microgram*day per milliliter (ug*day/mL)
Geometric Coefficient of Variation 48
|
—
|
PRIMARY outcome
Timeframe: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197Population: All randomized participants who received at least one dose of Ixekizumab in multiple dose group and had evaluable PK data.
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Outcome measures
| Measure |
Ixekizumab Single Dose
n=14 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
n=14 Participants
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
|
19.9 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 27
|
13.4 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: day 57 (Pre-dose), 59, 61, 64, 67, 71Population: All randomized participants multiple dose period who received at least one dose of Ixekizumab and had evaluable PK data.
Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Outcome measures
| Measure |
Ixekizumab Single Dose
n=14 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
n=14 Participants
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
|
224 Microgram*day per milliliter (ug*day/mL)
Geometric Coefficient of Variation 25
|
136 Microgram*day per milliliter (ug*day/mL)
Geometric Coefficient of Variation 31
|
PRIMARY outcome
Timeframe: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85Population: All randomized participants in Ixekizumab Q4W arm who received at least one dose of Ixekizumab and had evaluable PK data.
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
Outcome measures
| Measure |
Ixekizumab Single Dose
n=14 Participants
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
|
213 Microgram*day per milliliter (ug*day/mL)
Geometric Coefficient of Variation 29
|
—
|
Adverse Events
Ixekizumab Single Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Ixekizumab 80mg Q2W Multiple Dose
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Ixekizumab 80mg Q4W Multiple Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixekizumab Single Dose
n=12 participants at risk
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q2W Multiple Dose
n=14 participants at risk
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
n=15 participants at risk
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
Other adverse events
| Measure |
Ixekizumab Single Dose
n=12 participants at risk
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
|
Ixekizumab 80mg Q2W Multiple Dose
n=14 participants at risk
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
|
Ixekizumab 80mg Q4W Multiple Dose
n=15 participants at risk
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
21.4%
3/14 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
3/12 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Asthenia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 5 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Injection site swelling
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
General disorders
Nodule
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Gingivitis
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Tinea manuum
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
35.7%
5/14 • Number of events 5 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
20.0%
3/15 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Blood cholesterol increased
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Blood glucose increased
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Blood potassium decreased
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Blood triglycerides increased
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Electrocardiogram abnormal
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
21.4%
3/14 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Glucose urine present
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Low density lipoprotein increased
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Protein urine present
|
33.3%
4/12 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
14.3%
2/14 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
Urine leukocyte esterase positive
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 4 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 5 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
2/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail psoriasis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
41.7%
5/12 • Number of events 5 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
42.9%
6/14 • Number of events 10 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
13.3%
2/15 • Number of events 3 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
2/12 • Number of events 2 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
6.7%
1/15 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
7.1%
1/14 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/14 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
0.00%
0/15 • Baseline to end of the study (up to 20 weeks)
All Randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60