Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis (NCT NCT04285229)
NCT ID: NCT04285229
Last Updated: 2023-04-14
Results Overview
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Week 16
Results posted on
2023-04-14
Participant Flow
The study was designed to be conducted in three periods: * Double-Blind Treatment Period (Week 0 to Week 16) * Extended Treatment Period (Week 16 to Week 52) * Follow-up Period (at least 4 weeks and up to 12 weeks after the date of the participant's last visit)
Participant milestones
| Measure |
Placebo
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
Placebo/Ixekizumab 80mg Q4W - Extended Treatment Period
Participants from the "Placebo double-blind period" entered the extended treatment period where they received starting dose of 160 mg Ixekizumab at week 16 followed by 80 mg Ixekizumab Q4W by subcutaneous injection.
|
Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W - Extended Treatment Period
Participants from the "Ixekizumab 80mg Q4W double-blind period" entered the extended treatment period where they continued receiving the same treatment.
|
Placebo - Follow-up Period
Participants from the placebo arm entered the follow-up phase and were observed for safety. No treatments were administered.
|
Ixekizumab 80mg Q4W - Follow-up Period
Participants from the Ixekizumab treated arms (Ixekizumab 80mg Q4W, Placebo/Ixekizumab 80mg Q4W, Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W arms) entered the follow-up phase and were observed for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
73
|
74
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Received at Least One Dose of Study Drug
|
73
|
74
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
71
|
74
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period
STARTED
|
0
|
0
|
70
|
72
|
0
|
0
|
|
Extended Treatment Period
COMPLETED
|
0
|
0
|
69
|
64
|
0
|
0
|
|
Extended Treatment Period
NOT COMPLETED
|
0
|
0
|
1
|
8
|
0
|
0
|
|
Follow-up Period
STARTED
|
0
|
0
|
0
|
0
|
1
|
135
|
|
Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
123
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
Placebo/Ixekizumab 80mg Q4W - Extended Treatment Period
Participants from the "Placebo double-blind period" entered the extended treatment period where they received starting dose of 160 mg Ixekizumab at week 16 followed by 80 mg Ixekizumab Q4W by subcutaneous injection.
|
Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W - Extended Treatment Period
Participants from the "Ixekizumab 80mg Q4W double-blind period" entered the extended treatment period where they continued receiving the same treatment.
|
Placebo - Follow-up Period
Participants from the placebo arm entered the follow-up phase and were observed for safety. No treatments were administered.
|
Ixekizumab 80mg Q4W - Follow-up Period
Participants from the Ixekizumab treated arms (Ixekizumab 80mg Q4W, Placebo/Ixekizumab 80mg Q4W, Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W arms) entered the follow-up phase and were observed for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Extended Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
7
|
0
|
0
|
|
Extended Treatment Period
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Extended Treatment Period
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow-up Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
4
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Follow-up Period
Covid-19
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Follow-up Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 8.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants from bDMARD-naïve who had data for ASAS40.
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=66 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants
|
7.8 Percentage of Participants
|
40.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants Achieving an ASAS40 Response
|
8.2 Percentage of Participants
|
37.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants Achieving an ASAS20 Response
|
35.6 Percentage of Participants
|
59.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for ASDAS.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are 1. Total back pain 2. Patient global 3. Peripheral pain/swelling 4. Duration of morning stiffness and 5. CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, baseline C-reactive protein (CRP) status, Tumor necrosis factor (TNF) inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
|
-0.19 Units on a scale
Standard Error 0.103
|
-1.33 Units on a scale
Standard Error 0.100
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for BASDAI.
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Response
|
-0.90 Units on a scale
Standard Error 0.231
|
-2.39 Units on a scale
Standard Error 0.226
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for BASFI.
The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
|
-0.49 Units on a scale
Standard Error 0.237
|
-1.36 Units on a scale
Standard Error 0.230
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for MRI of the Spine.
MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, baseline CRP status, TNF inhibitors experience, and baseline value.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=72 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
|
-0.93 Units on a scale
Standard Error 1.550
|
-8.65 Units on a scale
Standard Error 1.507
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for SF-36 PCS score.
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS mean was determined by MMRM with factors for treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
|
1.23 Units on a scale
Standard Error 0.740
|
3.85 Units on a scale
Standard Error 0.716
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for SF-36 MCS score.
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS mean was determined by MMRM with factors for treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
|
-0.06 Units on a scale
Standard Error 1.027
|
0.45 Units on a scale
Standard Error 1.003
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for CRP.
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
|
2.65 milligram per liter (mg/L)
Standard Error 1.349
|
-10.10 milligram per liter (mg/L)
Standard Error 1.312
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for BASMI.
BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA). 1. Lateral Spinal Flexion 2. Tragus-to-wall distance 3. Lumbar Flexion (modified Schober) 4. Maximal intermalleolar distance and 5. Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=72 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
|
0.06 Units on a scale
Standard Error 0.093
|
-0.30 Units on a scale
Standard Error 0.090
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for MASES.
The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, baseline CRP status, TNF inhibitors experience, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=33 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
|
-1.06 Units on a scale
Standard Error 0.349
|
-1.77 Units on a scale
Standard Error 0.361
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had baseline and post-baseline data for MRI Sacroiliac Joint.
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with factors for treatment, baseline CRP status, TNF inhibitors experience, and baseline value.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=72 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
|
-1.31 units on a scale
Standard Error 1.021
|
-6.98 units on a scale
Standard Error 0.986
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants who had data for Anterior Uveitis.
Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Number of Participants With Anterior Uveitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from extended treatment period who had NSAID intake at baseline and week 52.
ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI). For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of NSAID (150 mg/day diclofenac) was set to a score value of 100. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac. ASAS-NSAID score = (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days). The total score range is from 0 to 100, higher the score greater the NSAID intake and 0 represents no intake at all. A negative change from baseline indicates less NSAID consumption.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=63 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
|
-30.71 Units on a scale
Standard Deviation 46.481
|
-26.13 Units on a scale
Standard Deviation 41.384
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who had data for Anti-Ixekizumab Antibodies.
A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a \>= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of \>= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Outcome measures
| Measure |
Placebo
n=73 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 Participants
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants With Anti-Ixekizumab Antibodies
|
4.1 Percentage of participants
|
13.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose and had evaluable PK data.
Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
|---|---|---|
|
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
|
3.89 microgram per milliliters (µg/mL)
Geometric Coefficient of Variation 52
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Ixekizumab 80mg Q4W
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo/Ixekizumab 80mg Q4W - Extended Treatment Period
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W - Extended Treatment Period
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo - Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ixekizumab 80mg Q4W - Follow-up Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=73 participants at risk
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 participants at risk
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
Placebo/Ixekizumab 80mg Q4W - Extended Treatment Period
n=70 participants at risk
Participants from the "Placebo double-blind period" entered the extended treatment period where they received starting dose of 160 mg Ixekizumab at week 16 followed by 80 mg Ixekizumab Q4W by subcutaneous injection.
|
Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W - Extended Treatment Period
n=72 participants at risk
Participants from the "Ixekizumab 80mg Q4W double-blind period" entered the extended treatment period where they continued receiving the same treatment.
|
Placebo - Follow-up Period
n=1 participants at risk
Participants from the placebo arm who entered the follow-up phase were observed for safety. No treatments were administered.
|
Ixekizumab 80mg Q4W - Follow-up Period
n=135 participants at risk
Ixekizumab treated participants (Ixekizumab 80mg Q4W, Placebo/Ixekizumab 80mg Q4W, Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W arms) who entered the follow-up phase were observed for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/74 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/74 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Male genital tract tuberculosis
|
0.00%
0/65 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/119 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/74 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Auricular haematoma
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign connective tissue neoplasm
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.74%
1/135 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Shock
|
1.4%
1/73 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/70 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=73 participants at risk
Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection.
|
Ixekizumab 80mg Q4W
n=74 participants at risk
Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection.
|
Placebo/Ixekizumab 80mg Q4W - Extended Treatment Period
n=70 participants at risk
Participants from the "Placebo double-blind period" entered the extended treatment period where they received starting dose of 160 mg Ixekizumab at week 16 followed by 80 mg Ixekizumab Q4W by subcutaneous injection.
|
Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W - Extended Treatment Period
n=72 participants at risk
Participants from the "Ixekizumab 80mg Q4W double-blind period" entered the extended treatment period where they continued receiving the same treatment.
|
Placebo - Follow-up Period
n=1 participants at risk
Participants from the placebo arm who entered the follow-up phase were observed for safety. No treatments were administered.
|
Ixekizumab 80mg Q4W - Follow-up Period
n=135 participants at risk
Ixekizumab treated participants (Ixekizumab 80mg Q4W, Placebo/Ixekizumab 80mg Q4W, Ixekizumab 80mg Q4W/Ixekizumab 80mg Q4W arms) who entered the follow-up phase were observed for safety. No treatments were administered.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.1%
6/74 • Number of events 7 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
3/70 • Number of events 6 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
2/72 • Number of events 3 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/74 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
4/70 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
2.7%
2/73 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.8%
5/74 • Number of events 7 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
20/70 • Number of events 64 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
34.7%
25/72 • Number of events 81 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.7%
2/73 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
4/74 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.6%
6/70 • Number of events 6 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
2/72 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
11/73 • Number of events 13 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.2%
9/74 • Number of events 12 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.1%
19/70 • Number of events 21 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
22.2%
16/72 • Number of events 22 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
5/135 • Number of events 5 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/8 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/16 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
2/73 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.8%
5/74 • Number of events 7 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/70 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
3/74 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
4/70 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
3/72 • Number of events 3 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
2/135 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
1.4%
1/73 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/74 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
2/70 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
4/72 • Number of events 6 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
1.4%
1/73 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/74 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
5/70 • Number of events 5 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
3/72 • Number of events 3 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.74%
1/135 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/73 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
2/74 • Number of events 2 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
4/70 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
6/72 • Number of events 7 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/135 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.7%
2/73 • Number of events 3 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.1%
6/74 • Number of events 7 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
7/70 • Number of events 8 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
4/72 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.0%
4/135 • Number of events 4 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/8 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/16 • Baseline to Follow-up (Up To 64 Weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60