Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment (NCT NCT02634801)

NCT ID: NCT02634801

Last Updated: 2019-10-09

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 162 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2019-10-09

Participant Flow

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.

Participant milestones

Measure	Ixekizumab 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.	Fumaric Acid Esters 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.	Methotrexate 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.
Treatment Period (Weeks 0 to 24) STARTED	54	54	54
Treatment Period (Weeks 0 to 24) Received at Least 1 Dose of Study Drug	54	52	52
Treatment Period (Weeks 0 to 24) COMPLETED	50	23	49
Treatment Period (Weeks 0 to 24) NOT COMPLETED	4	31	5
Extension Period (Weeks 24 to 36) STARTED	48	19	31
Extension Period (Weeks 24 to 36) COMPLETED	45	18	29
Extension Period (Weeks 24 to 36) NOT COMPLETED	3	1	2
Follow-up Period STARTED	41	26	46
Follow-up Period COMPLETED	36	18	38
Follow-up Period NOT COMPLETED	5	8	8

Reasons for withdrawal

Measure	Ixekizumab 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.	Fumaric Acid Esters 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.	Methotrexate 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.
Treatment Period (Weeks 0 to 24) Adverse Event	2	20	0
Treatment Period (Weeks 0 to 24) Lack of Efficacy	0	2	0
Treatment Period (Weeks 0 to 24) Lost to Follow-up	2	1	1
Treatment Period (Weeks 0 to 24) Protocol Violation	0	0	1
Treatment Period (Weeks 0 to 24) Withdrawal by Subject	0	8	3
Extension Period (Weeks 24 to 36) Adverse Event	0	0	1
Extension Period (Weeks 24 to 36) Lost to Follow-up	1	0	0
Extension Period (Weeks 24 to 36) Withdrawal by Subject	1	1	1
Extension Period (Weeks 24 to 36) Missing	1	0	0
Follow-up Period Lost to Follow-up	3	1	2
Follow-up Period Physician Decision	0	0	1
Follow-up Period Withdrawal by Subject	1	2	5
Follow-up Period Adverse Event	1	5	0

Baseline Characteristics

All randomized participants who had baseline data.

Baseline characteristics by cohort

Measure	Ixekizumab n=54 Participants 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.	Fumaric Acid Esters n=54 Participants 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.	Methotrexate n=54 Participants 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 n=162 Participants Total of all reporting groups
Age, Continuous	44.3 Years STANDARD_DEVIATION 13.84 • n=54 Participants • All randomized participants who had baseline data.	43.1 Years STANDARD_DEVIATION 14.16 • n=52 Participants • All randomized participants who had baseline data.	38.7 Years STANDARD_DEVIATION 12.90 • n=52 Participants • All randomized participants who had baseline data.	42.1 Years STANDARD_DEVIATION 13.77 • n=158 Participants • All randomized participants who had baseline data.
Sex: Female, Male Female	12 Participants n=54 Participants	11 Participants n=54 Participants	18 Participants n=54 Participants	41 Participants n=162 Participants
Sex: Female, Male Male	42 Participants n=54 Participants	43 Participants n=54 Participants	36 Participants n=54 Participants	121 Participants n=162 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=162 Participants
Race (NIH/OMB) Asian	1 Participants n=54 Participants	0 Participants n=54 Participants	3 Participants n=54 Participants	4 Participants n=162 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=162 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=162 Participants
Race (NIH/OMB) White	43 Participants n=54 Participants	44 Participants n=54 Participants	42 Participants n=54 Participants	129 Participants n=162 Participants
Race (NIH/OMB) More than one race	10 Participants n=54 Participants	10 Participants n=54 Participants	9 Participants n=54 Participants	29 Participants n=162 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=54 Participants	0 Participants n=162 Participants
Region of Enrollment Germany	54 Participants n=54 Participants	54 Participants n=54 Participants	54 Participants n=54 Participants	162 Participants n=162 Participants

PRIMARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Measure	Fumaric Acid Esters n=54 Participants 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.	Methotrexate n=54 Participants 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.	Ixekizumab n=54 Participants 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.
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24	22.2 Percentage of Participants	70.4 Percentage of Participants	90.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Measure	Fumaric Acid Esters n=54 Participants 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.	Methotrexate n=54 Participants 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.	Ixekizumab n=54 Participants 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.
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline	9.3 Percentage of Participants	38.9 Percentage of Participants	79.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Measure	Fumaric Acid Esters n=54 Participants 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.	Methotrexate n=54 Participants 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.	Ixekizumab n=54 Participants 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.
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline	3.7 Percentage of Participants	13.0 Percentage of Participants	40.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=52 Participants 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.	Ixekizumab n=54 Participants 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.
Change From Baseline in PASI Total Score	-4.93 units on a scale Interval -6.78 to -3.09	-14.61 units on a scale Interval -16.42 to -12.8	-16.68 units on a scale Interval -18.46 to -14.91

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=53 Participants 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.	Methotrexate n=52 Participants 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.	Ixekizumab n=52 Participants 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.
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	13.2 Percentage of Participants	51.9 Percentage of Participants	86.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=54 Participants 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.	Methotrexate n=54 Participants 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.	Ixekizumab n=54 Participants 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.
Percentage of Participants Achieving DLQI (0,1)	14.8 Percentage of Participants	37.0 Percentage of Participants	63.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=49 Participants 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.	Methotrexate n=49 Participants 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.	Ixekizumab n=52 Participants 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.
Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score	-5.37 units on a scale Interval -6.88 to -3.86	-12.81 units on a scale Interval -14.32 to -11.29	-13.08 units on a scale Interval -14.56 to -11.61

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=52 Participants 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.	Ixekizumab n=54 Participants 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.
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis	-5.26 % Body Surface Affected Interval -7.93 to -2.6	-18.46 % Body Surface Affected Interval -21.08 to -15.85	-20.64 % Body Surface Affected Interval -23.21 to -18.08

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=14 Participants 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.	Methotrexate n=9 Participants 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.	Ixekizumab n=12 Participants 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.
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score	-2.45 units on a scale Interval -6.03 to 1.13	-3.77 units on a scale Interval -8.1 to 0.56	-7.23 units on a scale Interval -10.88 to -3.59

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=39 Participants 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.	Methotrexate n=40 Participants 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.	Ixekizumab n=40 Participants 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.
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score	-6.76 units on a scale Interval -9.58 to -3.94	-18.56 units on a scale Interval -21.35 to -15.78	-20.85 units on a scale Interval -23.63 to -18.06

SECONDARY outcome

Timeframe: Week 24

Population: 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).

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.

Outcome measures

Measure	Fumaric Acid Esters n=41 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=43 Participants 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.
Patient Benefit Index (PBI) Overall Benefit Score	2.33 units on a scale Interval 1.81 to 2.84	2.66 units on a scale Interval 2.23 to 3.1	3.42 units on a scale Interval 2.99 to 3.84

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=52 Participants 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.	Ixekizumab n=53 Participants 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.
Change From Baseline on Itch Numeric Rating Scale (NRS) Score	-1.50 units on a scale Interval -2.15 to -0.84	-4.40 units on a scale Interval -5.05 to -3.76	-5.25 units on a scale Interval -5.89 to -4.61

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=52 Participants 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.	Ixekizumab n=53 Participants 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.
Change From Baseline on the Skin Pain Visual Analog Scale (VAS)	-7.20 Millimeter (mm) Interval -12.99 to -1.42	-28.29 Millimeter (mm) Interval -33.98 to -22.6	-33.83 Millimeter (mm) Interval -39.46 to -28.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=49 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=51 Participants 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.
Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16)	-1.01 units on a scale Interval -1.89 to -0.14	-2.50 units on a scale Interval -3.37 to -1.64	-2.16 units on a scale Interval -3.0 to -1.32

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=48 Participants 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.	Methotrexate n=49 Participants 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.	Ixekizumab n=50 Participants 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.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS)	0.57 units on a scale Interval -1.64 to 2.77	4.01 units on a scale Interval 1.83 to 6.19	4.45 units on a scale Interval 2.29 to 6.6

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=48 Participants 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.	Methotrexate n=49 Participants 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.	Ixekizumab n=50 Participants 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.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores	3.39 units on a scale Interval 1.19 to 5.59	6.99 units on a scale Interval 4.8 to 9.17	7.13 units on a scale Interval 4.99 to 9.27

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=54 Participants 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.
Change From Baseline on Patient's Global Assessment (PatGA) of Disease Severity	-0.87 units on a scale Interval -1.23 to -0.51	-2.39 units on a scale Interval -2.75 to -2.04	-3.12 units on a scale Interval -3.47 to -2.78

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=47 Participants 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.	Methotrexate n=48 Participants 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.	Ixekizumab n=52 Participants 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.
Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score	-5.18 units on a scale Interval -7.82 to -2.54	-15.05 units on a scale Interval -17.67 to -12.43	-19.87 units on a scale Interval -22.38 to 17.36

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=29 Participants 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.	Methotrexate n=27 Participants 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.	Ixekizumab n=35 Participants 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.
Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score	-0.14 units on a scale Interval -1.91 to 1.62	-3.41 units on a scale Interval -5.3 to -1.52	-6.58 units on a scale Interval -8.12 to -5.04

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=47 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=52 Participants 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.
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score	0.04 units on a scale Interval -0.01 to 0.09	0.15 units on a scale Interval 0.1 to 0.2	0.15 units on a scale Interval 0.11 to 0.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=46 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=52 Participants 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.
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Psoriasis (PSO) Index Score	0.05 units on a scale Interval 0.01 to 0.08	0.13 units on a scale Interval 0.1 to 0.16	0.15 units on a scale Interval 0.12 to 0.18

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=48 Participants 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.	Methotrexate n=50 Participants 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.	Ixekizumab n=52 Participants 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.
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Visual Analog Scale Score	6.08 Millimeter (mm) Interval 1.21 to 10.96	13.91 Millimeter (mm) Interval 9.14 to 18.69	16.91 Millimeter (mm) Interval 12.23 to 21.59

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=30 Participants 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.	Methotrexate n=39 Participants 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.	Ixekizumab n=26 Participants 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.
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score	-1.26 units on a scale Interval -7.69 to 5.17	0.06 units on a scale Interval -5.49 to 5.62	3.08 units on a scale Interval -3.79 to 9.96

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=32 Participants 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.	Methotrexate n=39 Participants 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.	Ixekizumab n=29 Participants 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.
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score	-5.29 units on a scale Interval -11.1 to 0.52	-20.32 units on a scale Interval -25.51 to -15.13	-22.70 units on a scale Interval -28.73 to -16.66

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=50 Participants 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.	Methotrexate n=48 Participants 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.	Ixekizumab n=53 Participants 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.
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work	-3.45 units on a scale Interval -9.38 to 2.47	-23.57 units on a scale Interval -29.58 to -17.55	-28.23 units on a scale Interval -33.99 to -22.47

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=30 Participants 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.	Methotrexate n=38 Participants 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.	Ixekizumab n=25 Participants 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.
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score	-6.20 units on a scale Interval -13.66 to 1.27	-19.80 units on a scale Interval -26.31 to -13.29	-18.20 units on a scale Interval -26.29 to -10.11

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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)

Outcome measures

Measure	Fumaric Acid Esters n=34 Participants 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.	Methotrexate n=36 Participants 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.	Ixekizumab n=33 Participants 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.
Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question	26.5 Percentage of Participants	66.7 Percentage of Participants	81.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	Fumaric Acid Esters n=24 Participants 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.	Methotrexate n=24 Participants 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.	Ixekizumab n=20 Participants 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.
Percentage of Participants Positive Responses to Genital Psoriasis Question	29.2 Percentage of participants	75.0 Percentage of participants	85.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Systemic Therapy Adherence Questionnaire (STAQ).

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.

Outcome measures

Measure	Fumaric Acid Esters n=22 Participants 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.	Methotrexate n=48 Participants 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.	Ixekizumab n=49 Participants 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.
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 13	2.75 units on a scale Interval 2.51 to 2.99	2.78 units on a scale Interval 2.61 to 2.94	2.84 units on a scale Interval 2.68 to 3.0
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 16	2.00 units on a scale Interval 1.68 to 2.32	2.43 units on a scale Interval 2.2 to 2.66	2.82 units on a scale Interval 2.6 to 3.04
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 20	2.00 units on a scale Interval 1.66 to 2.34	2.42 units on a scale Interval 2.17 to 2.66	2.76 units on a scale Interval 2.51 to 3.01
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 31	2.09 units on a scale Interval 1.79 to 2.39	2.29 units on a scale Interval 2.09 to 2.5	2.88 units on a scale Interval 2.68 to 3.08
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 32	1.95 units on a scale Interval 1.66 to 2.25	2.50 units on a scale Interval 2.3 to 2.7	2.86 units on a scale Interval 2.66 to 3.05
Mean Adherence on Medication and Satisfaction With Therapy (STAQ) STAQ item 35	2.14 units on a scale Interval 1.82 to 2.46	2.53 units on a scale Interval 2.31 to 2.75	2.80 units on a scale Interval 2.58 to 3.02

Adverse Events

Ixekizumab-Treatment Period

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Fumaric Acid Esters-Treatment Period

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Methotrexate-Treatment Period

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Ixekizumab-Extension Period

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Fumaric Acid Esters-Extension Period

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Methotrexate-Extension Period

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Follow-up Period

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ixekizumab-Treatment Period n=54 participants at risk 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.	Fumaric Acid Esters-Treatment Period n=52 participants at risk 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.	Methotrexate-Treatment Period n=52 participants at risk 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.	Ixekizumab-Extension Period n=48 participants at risk 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.	Fumaric Acid Esters-Extension Period n=19 participants at risk 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.	Methotrexate-Extension Period n=31 participants at risk 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.	Follow-up Period n=113 participants at risk Participants were allowed to continue the treatment administered during the treatment and extension period.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.88% 1/113 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Cardiac disorders Atrioventricular block complete	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Colitis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Gastritis erosive	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.88% 1/113 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Erysipelas	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Gastroenteritis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.88% 1/113 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Infected dermal cyst	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Nervous system disorders Sciatica	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.88% 1/113 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.

Other adverse events

Measure	Ixekizumab-Treatment Period n=54 participants at risk 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.	Fumaric Acid Esters-Treatment Period n=52 participants at risk 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.	Methotrexate-Treatment Period n=52 participants at risk 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.	Ixekizumab-Extension Period n=48 participants at risk 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.	Fumaric Acid Esters-Extension Period n=19 participants at risk 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.	Methotrexate-Extension Period n=31 participants at risk 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.	Follow-up Period n=113 participants at risk Participants were allowed to continue the treatment administered during the treatment and extension period.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	9.6% 5/52 • Number of events 5 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.8% 2/52 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Ear and labyrinth disorders Vertigo	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 5 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Abdominal pain upper	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	36.5% 19/52 • Number of events 26 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	11.5% 6/52 • Number of events 6 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Diarrhoea	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	46.2% 24/52 • Number of events 29 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	11.5% 6/52 • Number of events 6 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Nausea	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	9.6% 5/52 • Number of events 14 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Oral mucosal eruption	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Vomiting	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
General disorders Fatigue	7.4% 4/54 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	15.4% 8/52 • Number of events 14 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
General disorders Injection site erythema	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	10.5% 2/19 • Number of events 10 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	9.7% 3/31 • Number of events 13 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
General disorders Injection site pruritus	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
General disorders Injection site reaction	13.0% 7/54 • Number of events 23 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 9 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	15.8% 3/19 • Number of events 6 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	19.4% 6/31 • Number of events 31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
General disorders Injection site swelling	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	10.5% 2/19 • Number of events 10 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	9.7% 3/31 • Number of events 9 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Bronchitis	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	4.2% 2/48 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Gastroenteritis	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	4.2% 2/48 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Impetigo	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Nasopharyngitis	37.0% 20/54 • Number of events 23 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	17.3% 9/52 • Number of events 13 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	34.6% 18/52 • Number of events 21 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	37.5% 18/48 • Number of events 25 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	31.6% 6/19 • Number of events 7 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	32.3% 10/31 • Number of events 15 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Sinusitis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Tinea pedis	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	10.5% 2/19 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Infections and infestations Tooth infection	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.8% 3/52 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Investigations Weight increased	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	7.7% 4/52 • Number of events 6 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.8% 2/52 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	9.6% 5/52 • Number of events 5 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.2% 3/48 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	10.5% 2/19 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.2% 1/31 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Nervous system disorders Dizziness	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Nervous system disorders Headache	13.0% 7/54 • Number of events 7 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	7.7% 4/52 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	17.3% 9/52 • Number of events 12 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	3.8% 2/52 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 3/54 • Number of events 3 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	2.1% 1/48 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Alopecia	3.7% 2/54 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	4.2% 2/48 • Number of events 4 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	10.5% 2/19 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	6.5% 2/31 • Number of events 2 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Nail psoriasis	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	1.9% 1/52 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Xanthelasma	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Vascular disorders Flushing	0.00% 0/54 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	25.0% 13/52 • Number of events 19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/19 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.
Vascular disorders Haematoma	1.9% 1/54 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/52 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/48 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	5.3% 1/19 • Number of events 1 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/31 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.	0.00% 0/113 • Up to 48 Weeks All the randomized participants who received at least one dose of the study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60