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Trial record 8 of 29 for:    LY2439821

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT-P2)

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ClinicalTrials.gov Identifier: NCT02349295
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Placebo
Drug: Ixekizumab 80 mg Q4W
Drug: Ixekizumab 80 mg Q2W
Enrollment 363
Recruitment Details  
Pre-assignment Details The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by Extension Period from Week 24 to Week 156. Data collected after Week 24 will be reported after Study Completion.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W IR IxeQ4W IR IxeQ2W
Hide Arm/Group Description Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections followed by 1 SC injection every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24. Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
Period Title: Double Blind Treatment (Week 0-24)
Started 118 122 123 0 0
Completed 94 111 109 0 0
Not Completed 24 11 14 0 0
Reason Not Completed
Adverse Event             5             5             7             0             0
Lack of Efficacy             9             2             4             0             0
Withdrawal by Subject             7             2             2             0             0
Lost to Follow-up             2             1             1             0             0
Failure To Meet Randomization             1             1             0             0             0
Period Title: IR (Week 16-24)
Started 0 [1] 0 [1] 0 [1] 31 [2] 33 [3]
Completed 0 0 0 31 32
Not Completed 0 0 0 0 1
Reason Not Completed
Lack of Efficacy             0             0             0             0             1
[1]
Only IR participants were included.
[2]
IR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W.
[3]
IR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W Total
Hide Arm/Group Description Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22 Total of all reporting groups
Overall Number of Baseline Participants 118 122 123 363
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 118 participants 122 participants 123 participants 363 participants
51.5  (10.39) 52.6  (13.57) 51.7  (11.85) 51.9  (12.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 122 participants 123 participants 363 participants
Female 62 59 73 194
Male 56 63 50 169
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 122 participants 123 participants 363 participants
Hispanic or Latino 11 11 13 35
Not Hispanic or Latino 106 109 109 324
Unknown or Not Reported 1 2 1 4
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 122 participants 123 participants 363 participants
American Indian or Alaska Native 0 0 0 0
Asian 7 7 7 21
Native Hawaiian or Other Pacific Islander 0 1 0 1
Black or African American 1 1 1 3
White 108 111 113 332
More than one race 2 2 1 5
Unknown or Not Reported 0 0 1 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 122 participants 123 participants 363 participants
Czechia 8 4 8 20
United States 60 65 63 188
Taiwan 6 6 7 19
Poland 5 4 5 14
Italy 0 0 1 1
United Kingdom 5 6 5 16
Australia 2 2 3 7
France 6 6 5 17
Germany 11 13 12 36
Spain 15 16 14 45
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
Hide Description ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Measure Type: Number
Unit of Measure: Percentage of Participants
19.5 53.3 48.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).
Method Regression, Logistic
Comments 1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.74
Confidence Interval (2-Sided) 95%
2.65 to 8.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
Comments model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)
Type of Statistical Test Other
Comments 1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.79
Confidence Interval (2-Sided) 95%
2.12 to 6.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Hide Description HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.08) -0.6  (0.07) -0.4  (0.07)
3.Secondary Outcome
Title Percentage of Participants Achieving ACR20
Hide Description ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Measure Type: Number
Unit of Measure: Percentage of Participants
22.0 50.0 48.0
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
Hide Description ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Measure Type: Number
Unit of Measure: Percentage of Participants
5.1 35.2 33.3
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
Hide Description ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Measure Type: Number
Unit of Measure: Percentage of Participants
0 22.1 12.2
6.Secondary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
Hide Description The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 67 68 68
Measure Type: Number
Unit of Measure: Percentage of Participants
10.4 57.4 61.8
7.Secondary Outcome
Title Percentage of Patients Achieving Minimal Disease Activity (MDA)
Hide Description It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients’ disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Measure Type: Number
Unit of Measure: Percentage of Participants
3.4 27.9 23.6
8.Secondary Outcome
Title Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)
Hide Description The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0” indicates good score here.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 69 68 84
Measure Type: Number
Unit of Measure: Percentage of Participants
21.7 35.3 31.0
9.Secondary Outcome
Title Change From Baseline in Itch Numeric Rating Scale (NRS)
Hide Description The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.7  (0.40) -3.4  (0.39) -3.3  (0.39)
10.Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC)
Hide Description TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline TJC data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Tender Joint Count
-6.2  (1.96) -12.7  (1.87) -12.5  (1.77)
11.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC)
Hide Description SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline SJC data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Swollen Joint Count
-5.0  (1.05) -8.5  (0.99) -7.4  (0.94)
12.Secondary Outcome
Title Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
Hide Description The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline TJC and SJC data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-21.4  (3.97) -36.9  (3.74) -33.5  (3.58)
13.Secondary Outcome
Title Change From Baseline in Patients Global Assessment of Disease Activity VAS
Hide Description The patient’s overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-19.0  (3.91) -40.7  (3.68) -37.3  (3.53)
14.Secondary Outcome
Title Change From Baseline in Physicians Global Assessment of Disease Activity VAS
Hide Description The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-18.3  (3.98) -40.0  (3.85) -37.9  (3.75)
15.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP)
Hide Description C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline CRP data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: milligram per liter (mg/L)
-3.6  (1.87) -11.8  (1.76) -9.8  (1.68)
16.Secondary Outcome
Title Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
Hide Description The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline DAS28-CRP data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.8  (0.20) -2.1  (0.19) -1.8  (0.18)
17.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Hide Description The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-2.1  (0.38) -3.7  (0.36) -3.6  (0.35)
18.Secondary Outcome
Title Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
Hide Description The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline fatigue NRS data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.7  (0.37) -2.0  (0.35) -2.1  (0.34)
19.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
Hide Description The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline PCS data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
3.3  (1.36) 8.9  (1.29) 8.2  (1.23)
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
Hide Description The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline MCS data.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 118 122 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
0.9  (1.32) 3.6  (1.24) 4.0  (1.18)
21.Secondary Outcome
Title Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Hide Description Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 112 117 120
Measure Type: Number
Unit of Measure: Participants
1 8 4
22.Secondary Outcome
Title Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
Hide Description The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.
Time Frame All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
Arm/Group Title Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 102 101
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micograms per milliliter (mcg/mL)
2.46
(79.1%)
7.96
(71.1%)
23.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
Hide Description The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).
Time Frame All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
Arm/Group Title Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
Hide Arm/Group Description:
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Overall Number of Participants Analyzed 105 100
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*day/mL
141
(59.3%)
143
(57.5%)
24.Secondary Outcome
Title Percentage of Participants Achieving ACR20
Hide Description [Not Specified]
Time Frame Week 52 and up to 3 Years
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Percentage of Participants Achieving ACR 50
Hide Description [Not Specified]
Time Frame Week 52 and up to 3 Years
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Percentage of Participants Achieving ACR 70
Hide Description [Not Specified]
Time Frame Week 52 and up to 3 years
Outcome Measure Data Not Reported
Time Frame Double-Blind Treatment Period (Week 0 to Week 24), Inadequate responders (Week 16-24)
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W IR IxeQ4W IR IxeQ2W
Hide Arm/Group Description Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections followed by 1 SC injection every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12 and 14, 16, 18, 20, 22, and 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12, and 14, 16, 18, 20, 22, and 24. Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
All-Cause Mortality
Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W IR IxeQ4W IR IxeQ2W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W IR IxeQ4W IR IxeQ2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/118 (3.39%)      3/122 (2.46%)      8/123 (6.50%)      1/31 (3.23%)      0/33 (0.00%)    
Blood and lymphatic system disorders           
Iron deficiency anaemia  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Ear and labyrinth disorders           
Vertigo  1  0/118 (0.00%)  0 1/122 (0.82%)  1 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  1/118 (0.85%)  1 0/122 (0.00%)  0 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Anal fistula  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Infections and infestations           
Abscess jaw  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Anal abscess  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Perirectal abscess  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Injury, poisoning and procedural complications           
Fall  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Femoral neck fracture  1  1/118 (0.85%)  1 0/122 (0.00%)  0 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Foot fracture  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Tendon rupture  1  1/118 (0.85%)  1 0/122 (0.00%)  0 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes mellitus  1  0/118 (0.00%)  0 0/122 (0.00%)  0 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Myofascial pain syndrome  1  0/118 (0.00%)  0 1/122 (0.82%)  1 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Prostate cancer  1  0/56 (0.00%)  0 1/63 (1.59%)  1 0/50 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders           
Cervicobrachial syndrome  1  0/118 (0.00%)  0 1/122 (0.82%)  1 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/62 (0.00%)  0 0/59 (0.00%)  0 1/73 (1.37%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0
Reproductive system and breast disorders           
Adnexa uteri cyst  1  1/62 (1.61%)  1 0/59 (0.00%)  0 0/73 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0
Uterine prolapse  1  0/62 (0.00%)  0 0/59 (0.00%)  0 1/73 (1.37%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0
Surgical and medical procedures           
Knee arthroplasty  1  0/118 (0.00%)  0 0/122 (0.00%)  0 0/123 (0.00%)  0 1/31 (3.23%)  1 0/33 (0.00%)  0
Vascular disorders           
Peripheral arterial occlusive disease  1  1/118 (0.85%)  1 0/122 (0.00%)  0 0/123 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W IR IxeQ4W IR IxeQ2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/118 (19.49%)      39/122 (31.97%)      40/123 (32.52%)      6/31 (19.35%)      9/33 (27.27%)    
General disorders           
Injection site erythema  1  0/118 (0.00%)  0 2/122 (1.64%)  3 4/123 (3.25%)  20 0/31 (0.00%)  0 3/33 (9.09%)  4
Injection site induration  1  0/118 (0.00%)  0 1/122 (0.82%)  1 1/123 (0.81%)  1 0/31 (0.00%)  0 2/33 (6.06%)  2
Injection site pain  1  2/118 (1.69%)  4 0/122 (0.00%)  0 2/123 (1.63%)  6 0/31 (0.00%)  0 3/33 (9.09%)  7
Injection site reaction  1  1/118 (0.85%)  1 8/122 (6.56%)  22 15/123 (12.20%)  47 2/31 (6.45%)  5 4/33 (12.12%)  5
Hepatobiliary disorders           
Hepatic steatosis  1  1/118 (0.85%)  1 0/122 (0.00%)  0 0/123 (0.00%)  0 2/31 (6.45%)  2 0/33 (0.00%)  0
Infections and infestations           
Nasopharyngitis  1  4/118 (3.39%)  4 8/122 (6.56%)  10 4/123 (3.25%)  4 1/31 (3.23%)  1 0/33 (0.00%)  0
Sinusitis  1  2/118 (1.69%)  2 7/122 (5.74%)  7 5/123 (4.07%)  7 1/31 (3.23%)  1 0/33 (0.00%)  0
Upper respiratory tract infection  1  9/118 (7.63%)  12 11/122 (9.02%)  13 12/123 (9.76%)  12 0/31 (0.00%)  0 1/33 (3.03%)  1
Vulvovaginal candidiasis  1  0/62 (0.00%)  0 0/59 (0.00%)  0 2/73 (2.74%)  2 0/13 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders           
Psoriatic arthropathy  1  8/118 (6.78%)  8 2/122 (1.64%)  2 3/123 (2.44%)  3 0/31 (0.00%)  0 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  0/118 (0.00%)  0 7/122 (5.74%)  7 1/123 (0.81%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02349295     History of Changes
Other Study ID Numbers: 14310
I1F-MC-RHBE ( Other Identifier: Eli Lilly and Company )
2011-002328-42 ( EudraCT Number )
First Submitted: October 10, 2014
First Posted: January 28, 2015
Results First Submitted: September 6, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017