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A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (SPIRIT-H2H)

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ClinicalTrials.gov Identifier: NCT03151551
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Ixekizumab
Drug: Adalimumab
Enrollment 566
Recruitment Details Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
Pre-assignment Details Open-Label Treatment Period from Week 0 to Week 52 inclusive followed by Post-Treatment Follow-Up Period of up to a minimum of 12 weeks. Data beyond week 24 will be reported after final analysis for week 52 results.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Period Title: Overall Study
Started 283 283
Received at Least One Dose of Study Drug 283 283
IXE 160 mg at Baseline, 80 mg Q2W/Q4W 65 0 [1]
IXE 160 mg at Baseline, 80 mg Q4W 218 0 [1]
ADA 80 mg at Baseline, 40 mg Q2W 0 [2] 64
ADA 40 mg at Baseline, 40 mg Q2W 0 [2] 219
Completed 8 7
Not Completed 275 276
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             7             6
Protocol Violation             1             2
Lack of Efficacy             2             1
Physician Decision             2             0
Ongoing             262             266
[1]
Row represents Ixekizumab data only.
[2]
Row represents adalimumab data only.
Arm/Group Title Ixekizumab Adalimumab Total
Hide Arm/Group Description

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Total of all reporting groups
Overall Number of Baseline Participants 283 283 566
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 283 participants 566 participants
47.5  (12.02) 48.3  (12.30) 47.9  (12.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Female 121 133 254
Male 162 150 312
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Hispanic or Latino 63 65 128
Not Hispanic or Latino 198 194 392
Unknown or Not Reported 22 24 46
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
American Indian or Alaska Native 27 27 54
Asian 29 33 62
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 1 1
White 222 211 433
More than one race 5 11 16
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Argentina 31 27 58
Hungary 15 18 33
Ukraine 15 11 26
United Kingdom 13 7 20
Switzerland 1 3 4
India 20 26 46
Spain 24 18 42
Canada 5 5 10
Sweden 3 3 6
Austria 4 4 8
Netherlands 2 1 3
Belgium 6 5 11
Finland 5 6 11
Poland 24 29 53
Denmark 1 3 4
Mexico 32 33 65
South Africa 15 21 36
Italy 14 25 39
Israel 14 14 28
Australia 12 5 17
France 9 3 12
Germany 18 16 34
1.Primary Outcome
Title Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
Hide Description ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)& swollen joint count (SJC)& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36
(30.4 to 41.6)
27.9
(22.7 to 33.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
0.5 to 15.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving ACR50
Hide Description ACR50 response is defined as a ≥50% 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 (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.5
(44.7 to 56.4)
46.6
(40.8 to 52.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-4.3 to 12.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving PASI100
Hide Description PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if & only if they had achieved PASI=0 & BSA=0 at week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.1
(54.4 to 65.8)
46.6
(40.8 to 52.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
5.3 to 21.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in TJC
Hide Description TJC is determined by examination of 68 joint counts that are assessed for tenderness by pressure and joint manipulation on physical examination.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in SJC
Hide Description SJC is determined by examination of 66 joint counts that are classified as either swollen or not swollen. Swelling is defined as palpable fluctuating synovitis of the joint.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in Participant's Assessment of Pain VAS
Hide Description Participants are asked to assess his/her current level of arthritis pain by marking a vertical tick on a horizontal VAS with the left end marked as "no pain" and the right end marked "worst possible pain."
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Disease Activity
Hide Description The participant’s overall assessment of his or her PsA activity is recorded using a horizontal VAS.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity
Hide Description The investigator, who must be a physician, is asked to give an overall assessment of the severity of the participant’s current PsA activity using a horizontal VAS.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP)
Hide Description CRP is the ACR Core Set laboratory measure of acute-phase reactant.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in HAQ-DI
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 the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Percentage of Participants Simultaneously Achieving ACR50 and PASI100
Hide Description Proportion of participants simultaneously achieving ACR50 and PASI100 will be derived from the number of participants who have achieved PASI100 and achieved ACR50 divided by the total number of participants.
Time Frame Week 52
Outcome Measure Data Not Reported
12.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 milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 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.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants Achieving Minimal Disease Activity (MDA)
Hide Description MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
Time Frame Week 52
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Hide Description The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.
Time Frame Week 52
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change From Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified)
Hide Description The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline
Hide Description The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L).
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline
Hide Description The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)).
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline
Hide Description The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in circumference over the contra-lateral digit.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Change From Baseline in Psoriasis Body Surface Area (BSA)
Hide Description The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline
Hide Description The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Change From Baseline in the Itch 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 participant's itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Change From Baseline in Fatigue Severity NRS (Fatigue 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 rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)
Hide Description SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Change From Baseline in SF-36: Mental Component Summary (MCS)
Hide Description SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L])
Hide Description The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent’s health and a rating of his/her current health state using a VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Hide Description DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Change From Baseline on the Treatment Satisfaction Questionnaire
Hide Description The Treatment Satisfaction Questionnaire is a clinician-administered questionnaire which provides an assessment of the participant's opinion of the effectiveness, safety, and overall satisfaction of the study medication.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
Time Frame Up To Week 24
Adverse Event Reporting Description All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.
 
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description

160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants.

80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.

80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.

40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

All-Cause Mortality
Ixekizumab Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/283 (0.00%)      0/283 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ixekizumab Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/283 (2.12%)      15/283 (5.30%)    
Cardiac disorders     
Atrial fibrillation  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Myocardial ischaemia  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Gastrointestinal disorders     
Acute abdomen  1  0/283 (0.00%)  0 1/283 (0.35%)  1
General disorders     
Injection site rash  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Non-cardiac chest pain  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Pyrexia  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/283 (0.35%)  1 1/283 (0.35%)  1
Arthritis bacterial  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Infectious colitis  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Lower respiratory tract infection  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Lymph node tuberculosis  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Meningitis viral  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Pneumonia legionella  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Pyelonephritis  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Injury, poisoning and procedural complications     
Fall  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Hip fracture  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Pituitary tumour benign  1  1/283 (0.35%)  1 0/283 (0.00%)  0
Nervous system disorders     
Haemorrhagic stroke  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Polyneuropathy  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Respiratory, thoracic and mediastinal disorders     
Vocal cord thickening  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Vascular disorders     
Necrosis ischaemic  1  0/283 (0.00%)  0 1/283 (0.35%)  1
Peripheral artery occlusion  1  0/283 (0.00%)  0 1/283 (0.35%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixekizumab Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/283 (12.37%)      19/283 (6.71%)    
General disorders     
Injection site reaction  1  15/283 (5.30%)  22 4/283 (1.41%)  8
Infections and infestations     
Nasopharyngitis  1  24/283 (8.48%)  26 15/283 (5.30%)  16
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03151551     History of Changes
Other Study ID Numbers: 16687
I1F-MC-RHCF ( Other Identifier: Eli Lilly and Company )
2016-004585-25 ( EudraCT Number )
First Submitted: May 4, 2017
First Posted: May 12, 2017
Results First Submitted: February 22, 2019
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019