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Trial record 23 of 29 for:    LY2439821

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

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ClinicalTrials.gov Identifier: NCT02634801
Recruitment Status : Completed
First Posted : December 18, 2015
Results First Posted : July 18, 2018
Last Update Posted : December 6, 2018
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 Plaque Psoriasis
Interventions Drug: Fumaric Acid Esters
Drug: Methotrexate
Drug: Ixekizumab
Enrollment 162
Recruitment Details Treatment Period (Weeks 0 to 24), Extension Period (Weeks 24 to 36) followed by post-treatment follow-up period occurring from last treatment visit (week 36), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.
Pre-assignment Details  
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description

160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg Fumaric Acid Esters (FAE) given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg Methotrexate (MTX) given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Period Title: Treatment Period (Weeks 0 to 24)
Started 54 54 54
Received at Least 1 Dose of Study Drug 54 52 52
Completed 50 23 49
Not Completed 4 31 5
Reason Not Completed
Adverse Event             2             20             0
Lack of Efficacy             0             2             0
Lost to Follow-up             2             1             1
Protocol Violation             0             0             1
Withdrawal by Subject             0             8             3
Period Title: Extension Period (Weeks 24 to 36)
Started 48 [1] 19 [1] 31 [1]
Completed 45 18 29
Not Completed 3 1 2
Reason Not Completed
Adverse Event             0             0             1
Lost to Follow-up             1             0             0
Withdrawal by Subject             1             1             1
Missing             1             0             0
[1]
Participants had the option to enter the Extension Period or proceed directly to the Followup Period
Period Title: Follow-up Period
Started 41 [1] 26 [1] 46 [1]
Completed 36 18 38
Not Completed 5 8 8
Reason Not Completed
Lost to Follow-up             3             1             2
Physician Decision             0             0             1
Withdrawal by Subject             1             2             5
Adverse Event             1             5             0
[1]
Participants who discontinued previous periods had option to enter post treatment follow-up period.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate Total
Hide Arm/Group Description

160 mg ixekizumab given as two SC injection followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 54 54 54 162
Hide Baseline Analysis Population Description
All randomized participants who had baseline data.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 52 participants 52 participants 158 participants
44.3  (13.84) 43.1  (14.16) 38.7  (12.90) 42.1  (13.77)
[1]
Measure Analysis Population Description: All randomized participants who had baseline data.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
Female 12 11 18 41
Male 42 43 36 121
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
American Indian or Alaska Native 0 0 0 0
Asian 1 0 3 4
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 0 0 0 0
White 43 44 42 129
More than one race 10 10 9 29
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 54 participants 54 participants 54 participants 162 participants
54 54 54 162
1.Primary Outcome
Title Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 54 54
Measure Type: Number
Unit of Measure: Percentage of Participants
90.7 22.2 70.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Fumaric Acid Esters
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 4.08
Confidence Interval (2-Sided) 95%
2.46 to 6.77
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0137
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.06 to 1.56
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 54 54
Measure Type: Number
Unit of Measure: Percentage of Participants
79.6 9.3 38.9
3.Secondary Outcome
Title Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 54 54
Measure Type: Number
Unit of Measure: Percentage of Participants
40.7 3.7 13.0
4.Secondary Outcome
Title Change From Baseline in PASI Total Score
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). LS mean change from baseline in PASI was calculated using Analysis of Covariance (ANCOVA) with modified Baseline- Observation- Carried Forward (mBOCF) and with terms for baseline and treatment.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PASI.

mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 50 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-16.68
(-18.46 to -14.91)
-4.93
(-6.78 to -3.09)
-14.61
(-16.42 to -12.80)
5.Secondary Outcome
Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) and ≥2 Point Improvement From Baseline Among Those With sPGA Score ≥3 at Baseline
Hide Description The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 53 52
Measure Type: Number
Unit of Measure: Percentage of Participants
86.5 13.2 51.9
6.Secondary Outcome
Title Percentage of Participants Achieving DLQI (0,1)
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 54 54
Measure Type: Number
Unit of Measure: Percentage of Participants
63.0 14.8 37.0
7.Secondary Outcome
Title Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score
Hide Description The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. LS mean change from baseline in DLQI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for DLQI.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 49 49
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-13.08
(-14.56 to -11.61)
-5.37
(-6.88 to -3.86)
-12.81
(-14.32 to -11.29)
8.Secondary Outcome
Title Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
Hide Description

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.

LS mean change from baseline in BSA was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BSA.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 50 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % Body Surface Affected
-20.64
(-23.21 to -18.08)
-5.26
(-7.93 to -2.60)
-18.46
(-21.08 to -15.85)
9.Secondary Outcome
Title Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
Hide Description

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.

LS mean change from baseline in PPASI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PPASI.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 12 14 9
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-7.23
(-10.88 to -3.59)
-2.45
(-6.03 to 1.13)
-3.77
(-8.10 to 0.56)
10.Secondary Outcome
Title Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
Hide Description

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).

LS mean change from baseline in PSSI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Psoriasis Scalp.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 40 39 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-20.85
(-23.63 to -18.06)
-6.76
(-9.58 to -3.94)
-18.56
(-21.35 to -15.78)
11.Secondary Outcome
Title Patient Benefit Index (PBI) Overall Benefit Score
Hide Description

The PBI assessment consists of 2 steps: before treatment, every patient defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the patient rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for “did not apply to me” (5) and missing.

For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score.

LS mean was calculated using ANCOVA with LOCF and with a term for treatment.

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 study drug and had a baseline PBI questionnaire such that postbaseline PBI assessments can be valid (nonmissing).
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 43 41 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.42
(2.99 to 3.84)
2.33
(1.81 to 2.84)
2.66
(2.23 to 3.10)
12.Secondary Outcome
Title Change From Baseline on Itch Numeric Rating Scale (NRS) Score
Hide Description

The Itch NRS is a participant-administered single-item 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 (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Itch NRS score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 53 50 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-5.25
(-5.89 to -4.61)
-1.50
(-2.15 to -0.84)
-4.40
(-5.05 to -3.76)
13.Secondary Outcome
Title Change From Baseline on the Skin Pain Visual Analog Scale (VAS)
Hide Description

The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for skin pain VAS.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 53 50 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millimeter (mm)
-33.83
(-39.46 to -28.20)
-7.20
(-12.99 to -1.42)
-28.29
(-33.98 to -22.60)
14.Secondary Outcome
Title Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16)
Hide Description

QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for QIDS-SR16.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 51 49 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.16
(-3.00 to -1.32)
-1.01
(-1.89 to -0.14)
-2.50
(-3.37 to -1.64)
15.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) 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, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 PCS score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 50 48 49
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.45
(2.29 to 6.60)
0.57
(-1.64 to 2.77)
4.01
(1.83 to 6.19)
16.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores
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, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 MCS score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 50 48 49
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.13
(4.99 to 9.27)
3.39
(1.19 to 5.59)
6.99
(4.80 to 9.17)
17.Secondary Outcome
Title Change From Baseline on Patient’s Global Assessment (PatGA) of Disease Severity
Hide Description

The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PatGA.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 54 50 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.12
(-3.47 to -2.78)
-0.87
(-1.23 to -0.51)
-2.39
(-2.75 to -2.04)
18.Secondary Outcome
Title Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score
Hide Description

PSAB measure is a 3-item scale designed to measure the degree of bothersomeness of skin appearance due to Ps in participants with Ps. Participants are asked to indicate on 3 numeric rating scales (NRS) from 0 (not at all bothered) to 10 (extremely bothered) how bothered they are by any redness or discoloration, thickness, and scaling or flaking on their skin due to Ps.

The scores from the 3 NRS items are summed for a total score ranging from 0 to 30, where 0 indicating no bothersomeness and 30 indicating greater bothersomeness.

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PSAB.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 47 48
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-19.87
(-22.38 to 17.36)
-5.18
(-7.82 to -2.54)
-15.05
(-17.67 to -12.43)
19.Secondary Outcome
Title Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score
Hide Description

NAPPA is a clinical and participant-reported outcomes tool, and consists of 3 components: a questionnaire assessing nail-specific quality of life NAPPA-QoL (Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life), a 2-part questionnaire assessing participant relevant needs and treatment benefits NAPPA-PBI (Nail Assessment in Psoriasis and Psoriatic Arthritis – Patient Benefit Index), and a clinical assessment of objective finger nail psoriasis severity NAPPA-CLIN.

Sum of all assessed finger and toes ranging between 0 (no involvement) to 16 (worst involvement).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who had palmoplantar, scalp, or nail involvement at baseline.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 35 29 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-6.58
(-8.12 to -5.04)
-0.14
(-1.91 to 1.62)
-3.41
(-5.30 to -1.52)
20.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score
Hide Description

The European Quality of Life - 5 Dimensions 5 Level (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 a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a United Kingdom (UK) Population value set to each of the levels in each dimension. This produced participant-level index scores between -0.594 and 1.0 (worse to better health).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L Index.mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 47 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.15
(0.11 to 0.20)
0.04
(-0.01 to 0.09)
0.15
(0.10 to 0.20)
21.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Psoriasis (PSO) Index Score
Hide Description

The European Quality of Life - 5 Dimensions 5 Level (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 a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L "Bolt On" PSO-Index.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 46 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.15
(0.12 to 0.18)
0.05
(0.01 to 0.08)
0.13
(0.10 to 0.16)
22.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Visual Analog Scale Score
Hide Description

The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L + Bolt on VAS.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 52 48 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millimeter (mm)
16.91
(12.23 to 21.59)
6.08
(1.21 to 10.96)
13.91
(9.14 to 18.69)
23.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 26 30 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.08
(-3.79 to 9.96)
-1.26
(-7.69 to 5.17)
0.06
(-5.49 to 5.62)
24.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO Presenteeism score.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 29 32 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-22.70
(-28.73 to -16.66)
-5.29
(-11.10 to 0.52)
-20.32
(-25.51 to -15.13)
25.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 53 50 48
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-28.23
(-33.99 to -22.47)
-3.45
(-9.38 to 2.47)
-23.57
(-29.58 to -17.55)
26.Secondary Outcome
Title Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score
Hide Description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).

LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.

mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 25 30 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-18.20
(-26.29 to -10.11)
-6.20
(-13.66 to 1.27)
-19.80
(-26.31 to -13.29)
27.Secondary Outcome
Title Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question
Hide Description

Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.

Following set of binary questions were asked to check the satisfaction of participants.

  1. Does the participant currently have visible psoriasis on face/neck? (Yes/No)
  2. Does the participant currently have psoriasis on the genital area? (Yes/No)
Time Frame Week 24
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Hide Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for binary questions.

Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 33 34 36
Measure Type: Number
Unit of Measure: Percentage of Participants
81.8 26.5 66.7
28.Secondary Outcome
Title Percentage of Participants Positive Responses to Genital Psoriasis Question
Hide Description

Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.

Following set of binary questions were asked to check the satisfaction of participants.

  1. Does the patient currently have visible psoriasis on face/neck? (Yes/No)
  2. Does the patient currently have psoriasis on the genital area? (Yes/No) The genital area includes the labia majora (hair-bearing), labia minora modified mucus membrane, and perineum in female patients; and the penis glans, penis – shaft, and scrotum in male patients.
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 study drug and had baseline and a post-baseline measurement for binary questions.

Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 20 24 24
Measure Type: Number
Unit of Measure: Percentage of participants
85.0 29.2 75.0
29.Secondary Outcome
Title Mean Adherence on Medication and Satisfaction With Therapy (STAQ)
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Systemic Therapy Adherence Questionnaire (STAQ) is a 38 item questionnaire that was developed by shortening and adapting the Topical Treatment Adherence Questionnaire (TTAQ) for administration to participants under systemic therapy. The following STAQ items are of special interest for this study.

  1. STAQ item 13 (The treatment does not affect my sex life)
  2. STAQ item 16 (I am enjoying life again as a result of the treatment)
  3. STAQ item 20 (The side effects of the treatment were acceptable)
  4. STAQ item 31 (I am satisfied with the efficacy of the treatment)
  5. STAQ item 32 (I am satisfied with the tolerability of the treatment)
  6. STAQ item 35 (The positive aspects of the treatment outweigh the negative ones).

The STAQ items are on a 4-point Likert scale with scores between 0 (strong disagreement) and 3 (strong agreement). LS mean was calculated using ANCOVA with term for treatment.

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 study drug and had a post-baseline measurement for Systemic Therapy Adherence Questionnaire (STAQ).
Arm/Group Title Ixekizumab Fumaric Acid Esters Methotrexate
Hide Arm/Group Description:

160 mg ixekizumab given as two SC injections followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

Overall Number of Participants Analyzed 49 22 48
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
STAQ item 13 Number Analyzed 44 participants 20 participants 40 participants
2.84
(2.68 to 3.00)
2.75
(2.51 to 2.99)
2.78
(2.61 to 2.94)
STAQ item 16 Number Analyzed 45 participants 21 participants 42 participants
2.82
(2.60 to 3.04)
2.00
(1.68 to 2.32)
2.43
(2.20 to 2.66)
STAQ item 20 Number Analyzed 42 participants 22 participants 43 participants
2.76
(2.51 to 3.01)
2.00
(1.66 to 2.34)
2.42
(2.17 to 2.66)
STAQ item 31 Number Analyzed 49 participants 22 participants 48 participants
2.88
(2.68 to 3.08)
2.09
(1.79 to 2.39)
2.29
(2.09 to 2.50)
STAQ item 32 Number Analyzed 49 participants 22 participants 48 participants
2.86
(2.66 to 3.05)
1.95
(1.66 to 2.25)
2.50
(2.30 to 2.70)
STAQ item 35 Number Analyzed 45 participants 22 participants 47 participants
2.80
(2.58 to 3.02)
2.14
(1.82 to 2.46)
2.53
(2.31 to 2.75)
Time Frame Up to 48 Weeks
Adverse Event Reporting Description All the randomized participants who received at least one dose of the study drug.
 
Arm/Group Title Ixekizumab-Treatment Period Fumaric Acid Esters-Treatment Period Methotrexate-Treatment Period Ixekizumab-Extension Period Fumaric Acid Esters-Extension Period Methotrexate-Extension Period Follow-up Period
Hide Arm/Group Description

160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.

Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.

7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks. Participants were allowed to continue the treatment administered during the treatment and extension period.
All-Cause Mortality
Ixekizumab-Treatment Period Fumaric Acid Esters-Treatment Period Methotrexate-Treatment Period Ixekizumab-Extension Period Fumaric Acid Esters-Extension Period Methotrexate-Extension Period Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ixekizumab-Treatment Period Fumaric Acid Esters-Treatment Period Methotrexate-Treatment Period Ixekizumab-Extension Period Fumaric Acid Esters-Extension Period Methotrexate-Extension Period Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/54 (1.85%)      3/52 (5.77%)      1/52 (1.92%)      3/48 (6.25%)      1/19 (5.26%)      4/31 (12.90%)      4/113 (3.54%)    
Blood and lymphatic system disorders               
Lymphadenopathy  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 1/113 (0.88%)  1
Cardiac disorders               
Atrioventricular block complete  1  1/54 (1.85%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  0/54 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Colitis  1  0/54 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Gastritis erosive  1  0/54 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Hepatobiliary disorders               
Hepatic cirrhosis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 1/113 (0.88%)  1
Infections and infestations               
Erysipelas  1  0/54 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Gastroenteritis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 1/113 (0.88%)  1
Infected dermal cyst  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Intervertebral disc protrusion  1  0/54 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 1/48 (2.08%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Osteoarthritis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Anogenital warts  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1 0/113 (0.00%)  0
Invasive lobular breast carcinoma  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Pancreatic neuroendocrine tumour  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Nervous system disorders               
Sciatica  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 1/113 (0.88%)  1
Respiratory, thoracic and mediastinal disorders               
Tonsillar hypertrophy  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1 0/113 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixekizumab-Treatment Period Fumaric Acid Esters-Treatment Period Methotrexate-Treatment Period Ixekizumab-Extension Period Fumaric Acid Esters-Extension Period Methotrexate-Extension Period Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/54 (68.52%)      39/52 (75.00%)      38/52 (73.08%)      24/48 (50.00%)      15/19 (78.95%)      18/31 (58.06%)      0/113 (0.00%)    
Blood and lymphatic system disorders               
Lymphopenia  1  0/54 (0.00%)  0 5/52 (9.62%)  5 2/52 (3.85%)  2 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Ear and labyrinth disorders               
Middle ear inflammation  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Vertigo  1  2/54 (3.70%)  2 3/52 (5.77%)  3 3/52 (5.77%)  5 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain upper  1  2/54 (3.70%)  2 19/52 (36.54%)  26 6/52 (11.54%)  6 1/48 (2.08%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Diarrhoea  1  1/54 (1.85%)  1 24/52 (46.15%)  29 6/52 (11.54%)  6 1/48 (2.08%)  1 1/19 (5.26%)  1 1/31 (3.23%)  1 0/113 (0.00%)  0
Dyspepsia  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Flatulence  1  0/54 (0.00%)  0 3/52 (5.77%)  3 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Nausea  1  1/54 (1.85%)  1 3/52 (5.77%)  4 5/52 (9.62%)  14 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Oral mucosal eruption  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Vomiting  1  0/54 (0.00%)  0 3/52 (5.77%)  4 0/52 (0.00%)  0 1/48 (2.08%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
General disorders               
Fatigue  1  4/54 (7.41%)  4 3/52 (5.77%)  3 8/52 (15.38%)  14 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Injection site erythema  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 2/19 (10.53%)  10 3/31 (9.68%)  13 0/113 (0.00%)  0
Injection site pruritus  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  3 1/31 (3.23%)  1 0/113 (0.00%)  0
Injection site reaction  1  7/54 (12.96%)  23 0/52 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  9 3/19 (15.79%)  6 6/31 (19.35%)  31 0/113 (0.00%)  0
Injection site swelling  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 2/19 (10.53%)  10 3/31 (9.68%)  9 0/113 (0.00%)  0
Infections and infestations               
Bronchitis  1  1/54 (1.85%)  1 1/52 (1.92%)  1 1/52 (1.92%)  1 2/48 (4.17%)  2 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Gastroenteritis  1  1/54 (1.85%)  1 1/52 (1.92%)  1 0/52 (0.00%)  0 2/48 (4.17%)  2 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Impetigo  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Nasopharyngitis  1  20/54 (37.04%)  23 9/52 (17.31%)  13 18/52 (34.62%)  21 18/48 (37.50%)  25 6/19 (31.58%)  7 10/31 (32.26%)  15 0/113 (0.00%)  0
Sinusitis  1  0/54 (0.00%)  0 1/52 (1.92%)  1 1/52 (1.92%)  1 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Tinea pedis  1  2/54 (3.70%)  2 0/52 (0.00%)  0 1/52 (1.92%)  1 1/48 (2.08%)  1 2/19 (10.53%)  2 0/31 (0.00%)  0 0/113 (0.00%)  0
Tooth infection  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Injury, poisoning and procedural complications               
Arthropod bite  1  0/54 (0.00%)  0 0/52 (0.00%)  0 3/52 (5.77%)  3 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Investigations               
Aspartate aminotransferase increased  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 1/31 (3.23%)  1 0/113 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/54 (0.00%)  0 3/52 (5.77%)  3 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Weight increased  1  1/54 (1.85%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Metabolism and nutrition disorders               
Hyperlipidaemia  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  2/54 (3.70%)  2 0/52 (0.00%)  0 4/52 (7.69%)  6 1/48 (2.08%)  1 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Back pain  1  1/54 (1.85%)  1 2/52 (3.85%)  2 5/52 (9.62%)  5 3/48 (6.25%)  3 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Bursitis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Musculoskeletal pain  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Myalgia  1  0/54 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0 2/19 (10.53%)  4 0/31 (0.00%)  0 0/113 (0.00%)  0
Pain in extremity  1  1/54 (1.85%)  1 1/52 (1.92%)  1 0/52 (0.00%)  0 1/48 (2.08%)  1 1/19 (5.26%)  1 1/31 (3.23%)  1 0/113 (0.00%)  0
Nervous system disorders               
Dizziness  1  2/54 (3.70%)  2 0/52 (0.00%)  0 1/52 (1.92%)  1 1/48 (2.08%)  1 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Headache  1  7/54 (12.96%)  7 4/52 (7.69%)  4 9/52 (17.31%)  12 1/48 (2.08%)  1 1/19 (5.26%)  1 2/31 (6.45%)  2 0/113 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Bronchial hyperreactivity  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Cough  1  1/54 (1.85%)  1 2/52 (3.85%)  2 1/52 (1.92%)  1 1/48 (2.08%)  1 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Oropharyngeal pain  1  3/54 (5.56%)  3 1/52 (1.92%)  1 1/52 (1.92%)  1 1/48 (2.08%)  1 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Skin and subcutaneous tissue disorders               
Alopecia  1  2/54 (3.70%)  2 0/52 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2 0/113 (0.00%)  0
Dermatitis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Eczema  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 2/48 (4.17%)  4 2/19 (10.53%)  2 2/31 (6.45%)  2 0/113 (0.00%)  0
Ingrowing nail  1  0/54 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Nail psoriasis  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Night sweats  1  0/54 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Xanthelasma  1  0/54 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Vascular disorders               
Flushing  1  0/54 (0.00%)  0 13/52 (25.00%)  19 0/52 (0.00%)  0 0/48 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0 0/113 (0.00%)  0
Haematoma  1  1/54 (1.85%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/48 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0 0/113 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
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: NCT02634801     History of Changes
Other Study ID Numbers: 16190
I1F-EW-RHBZ ( Other Identifier: Eli Lilly and Company )
2015-002649-69 ( EudraCT Number )
First Submitted: December 16, 2015
First Posted: December 18, 2015
Results First Submitted: November 27, 2017
Results First Posted: July 18, 2018
Last Update Posted: December 6, 2018