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

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03364309

Enrollment

438

Registered

2017-12-06

Start date

2018-04-26

Completion date

2020-06-04

Last updated

2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

plaque psoriasis, ixekizumab, skin condition, skin disease, itching, psoriasis vulgaris, immune-mediated systemic disease, skin lesions, scaly patches, papules

Brief summary

The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.

Detailed description

Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.

Interventions

DRUGIxekizumab

Administered SC

DRUGPlacebo

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline. * Have ≥10% BSA involvement at screening and baseline. * Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline. * Are candidates for phototherapy and/or systemic therapy.

Exclusion criteria

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline. * Drug-induced psoriasis. * Ongoing use of prohibited treatments. * Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor. * Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to baseline, whichever is longer. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement	Week 12	The sPGA is the physician's determination of the participant's 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.
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)	Week 12	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 by itself 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).

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	Week 12	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 by itself and the scores were 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).
Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4	Week 12	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	Baseline, Week 12	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). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement	Baseline, Week 12	NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis	Baseline, Week 12	The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a 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 was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement	Baseline, Week 12	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 was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)	Week 12	The sPGA is the physician's determination of the participant's 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 assessed as 0, indicates complete resolution of plaque Ps.
Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score	Baseline, Week 12	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. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline on Patient Global Assessment of Disease Severity	Baseline, Week 12	The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement	Baseline, Week 12	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 Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Change From Baseline on the Joint Pain Visual Analog Scale (VAS)	Baseline, Week 12	The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Percentage of Participants With Anti-Ixekizumab Antibodies	Baseline through Week 12	Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	Baseline, Week 12	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. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)	Week 12	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 by itself and the scores were 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).

Countries

China

Participant flow

Recruitment details

Responders were defined as achieving an sPGA score of 0 or 1. Non-responders were defined as having an sPGA score of \>1. Responders were monitored for relapse, relapse (loss of response) occurring after Week 12 (Visit 7) was defined as an sPGA score of ≥3. In Re-treatment (Maintenance) Period, participants who relapsed received continued treatment of ixekizumab 80 mg Q4W, regardless of their treatment assignment.

Pre-assignment details

Induction Dosing Period: Week 0 (baseline) to Week 12. Maintenance Dosing Period and Re-treatment (Maintenance) Period: Week 12 to Week 60. Post-Treatment Follow-Up Period: Occurred from last treatment period visit or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.

Participants by arm

Arm	Count
Placebo Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.	88
Ixekizumab 80mg Q4W Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period	174
Ixekizumab 80mg Q2W Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period	176
Total	438

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG012	FG013	FG014	FG015	FG016	FG017	FG018
Induction Period	Adverse Event	4	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period	Lost to Follow-up	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period	Physician Decision	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period	Withdrawal by Subject	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period	Adverse Event	0	0	0	0	2	0	3	0	1	0	2	0	0	0	0	0	0	0
Maintenance Period	Death	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period	Lack of Efficacy	0	0	0	0	0	0	0	0	1	3	2	0	0	0	0	0	0	0
Maintenance Period	Lost to Follow-up	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period	Miscellaneous	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Maintenance Period	Relapsed	0	0	0	43	7	45	10	2	0	0	0	0	0	0	0	0	0	0
Maintenance Period	Withdrawal by Subject	0	0	0	1	3	1	3	0	1	1	2	0	0	0	0	0	0	0
Post-Treatment Followup Period	Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	6	1
Post-Treatment Followup Period	Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Post-Treatment Followup Period	Miscellaneous	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0
Post-Treatment Followup Period	Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	19	1
Re-treatment (Maintenance) Period	Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Re-treatment (Maintenance) Period	Relapse	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0
Re-treatment (Maintenance) Period	Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1	0	0	0

Baseline characteristics

Characteristic	Placebo	Total	Ixekizumab 80mg Q2W	Ixekizumab 80mg Q4W
Age, Continuous	41.9 years STANDARD_DEVIATION 12.38	40.5 years STANDARD_DEVIATION 11.37	39.2 years STANDARD_DEVIATION 10.53	41.2 years STANDARD_DEVIATION 11.59
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	88 Participants	438 Participants	176 Participants	174 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment China	88 Participants	438 Participants	176 Participants	174 Participants
Sex: Female, Male Female	24 Participants	103 Participants	34 Participants	45 Participants
Sex: Female, Male Male	64 Participants	335 Participants	142 Participants	129 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk
deaths Total, all-cause mortality	0 / 88	0 / 174	0 / 176	0 / 47	0 / 92	0 / 50	0 / 100	0 / 3	1 / 79	0 / 31	0 / 23	0 / 2	0 / 43	0 / 7	0 / 45	0 / 10	0 / 11	0 / 375	0 / 2
other Total, other adverse events	25 / 88	89 / 174	97 / 176	24 / 47	68 / 92	22 / 50	66 / 100	1 / 3	58 / 79	22 / 31	14 / 23	1 / 2	24 / 43	4 / 7	27 / 45	5 / 10	0 / 11	27 / 375	0 / 2
serious Total, serious adverse events	3 / 88	2 / 174	1 / 176	1 / 47	5 / 92	1 / 50	2 / 100	1 / 3	5 / 79	0 / 31	1 / 23	0 / 2	1 / 43	0 / 7	2 / 45	0 / 10	0 / 11	7 / 375	0 / 2

Outcome results

Primary

Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

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 by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Time frame: Week 12

Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)	8.0 Percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)	87.4 Percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)	93.8 Percentage of participants

p-value: <0.00195% CI: [32.76, 99.99]Regression, Logistic

p-value: <0.00195% CI: [64.87, 99.99]Regression, Logistic

Primary

Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline.

Time frame: Week 12

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 at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement	3.4 Percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement	79.9 Percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement	86.4 Percentage of participants

p-value: <0.000195% CI: [33.57, 99.99]Regression, Logistic

p-value: <0.00195% CI: [52.49, 99.99]Regression, Logistic

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

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). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline DLQI total score.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	0.92 units on a scale	Standard Error 0.495
Ixekizumab 80mg Q4W	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	-8.60 units on a scale	Standard Error 0.346
Ixekizumab 80mg Q2W	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	-8.86 units on a scale	Standard Error 0.343

p-value: <0.00195% CI: [-10.71, -8.33]Mixed Models Analysis

p-value: <0.00195% CI: [-10.96, -8.59]Mixed Models Analysis

Secondary

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

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. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had post baseline SF-36 PCS score.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	-1.812 units on a scale	Standard Error 0.5492
Ixekizumab 80mg Q4W	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	4.417 units on a scale	Standard Error 0.3815
Ixekizumab 80mg Q2W	Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	4.724 units on a scale	Standard Error 0.3766

p-value: <0.00195% CI: [4.915, 7.541]Mixed Models Analysis

p-value: <0.00195% CI: [5.225, 7.847]Mixed Models Analysis

Secondary

Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had post baseline SF-36 MCS score.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score	-1.233 units on a scale	Standard Error 0.7798
Ixekizumab 80mg Q4W	Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score	3.960 units on a scale	Standard Error 0.5414
Ixekizumab 80mg Q2W	Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score	4.129 units on a scale	Standard Error 0.5342

p-value: <0.00195% CI: [3.328, 7.058]Mixed Models Analysis

p-value: <0.00195% CI: [3.503, 7.222]Mixed Models Analysis

Secondary

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement

NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline fingernail involvement.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement	-1.26 units on a scale	Standard Error 1.365
Ixekizumab 80mg Q4W	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement	-11.35 units on a scale	Standard Error 0.967
Ixekizumab 80mg Q2W	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement	-10.07 units on a scale	Standard Error 0.974

p-value: <0.00195% CI: [-13.38, -6.79]Mixed Models Analysis

p-value: <0.00195% CI: [-12.11, -5.51]Mixed Models Analysis

Secondary

Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement

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 Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline palmoplantar psoriasis involvement.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement	-2.99 units on a scale	Standard Error 0.861
Ixekizumab 80mg Q4W	Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement	-6.34 units on a scale	Standard Error 0.688
Ixekizumab 80mg Q2W	Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement	-7.78 units on a scale	Standard Error 0.626

p-value: 0.00395% CI: [-5.56, -1.15]Mixed Models Analysis

p-value: <0.00195% CI: [-6.9, -2.67]Mixed Models Analysis

Secondary

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a 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 was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had postbaseline BSA involvement.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis	-0.36 Percent of BSA	Standard Error 1.66
Ixekizumab 80mg Q4W	Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis	-35.32 Percent of BSA	Standard Error 1.157
Ixekizumab 80mg Q2W	Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis	-36.70 Percent of BSA	Standard Error 1.146

p-value: <0.00195% CI: [-38.94, -30.98]Mixed Models Analysis

p-value: <0.00195% CI: [-40.3, -32.37]Mixed Models Analysis

Secondary

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement

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 was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline scalp involvement.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement	-1.59 units on a scale	Standard Error 0.787
Ixekizumab 80mg Q4W	Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement	-18.33 units on a scale	Standard Error 0.544
Ixekizumab 80mg Q2W	Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement	-19.52 units on a scale	Standard Error 0.539

p-value: <0.00195% CI: [-18.62, -14.86]Mixed Models Analysis

p-value: <0.00195% CI: [-19.8, -16.05]Mixed Models Analysis

Secondary

Change From Baseline on Patient Global Assessment of Disease Severity

The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had postbaseline patient global assessment score.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline on Patient Global Assessment of Disease Severity	-0.5 units on a scale	Standard Error 0.12
Ixekizumab 80mg Q4W	Change From Baseline on Patient Global Assessment of Disease Severity	-3.1 units on a scale	Standard Error 0.08
Ixekizumab 80mg Q2W	Change From Baseline on Patient Global Assessment of Disease Severity	-3.1 units on a scale	Standard Error 0.08

p-value: <0.00195% CI: [-2.9, -2.4]Mixed Models Analysis

p-value: <0.00195% CI: [-2.9, -2.3]Mixed Models Analysis

Secondary

Change From Baseline on the Joint Pain Visual Analog Scale (VAS)

The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time frame: Baseline, Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline psoriatic arthritis.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline on the Joint Pain Visual Analog Scale (VAS)	-12.2 millimeter (mm)	Standard Error 9.64
Ixekizumab 80mg Q4W	Change From Baseline on the Joint Pain Visual Analog Scale (VAS)	-39.6 millimeter (mm)	Standard Error 5.48
Ixekizumab 80mg Q2W	Change From Baseline on the Joint Pain Visual Analog Scale (VAS)	-37.4 millimeter (mm)	Standard Error 4.75

p-value: 0.02295% CI: [-50.5, -4.3]Mixed Models Analysis

p-value: 0.03195% CI: [-47.8, -2.5]Mixed Models Analysis

Secondary

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

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 by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Time frame: Week 12

Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	0.0 Percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	29.3 Percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	33.0 Percentage of participants

Secondary

Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

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 by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Time frame: Week 12

Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)	2.3 Percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)	75.9 Percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)	82.4 Percentage of participants

p-value: <0.00195% CI: [31.88, 99.99]Regression, Logistic

p-value: <0.00195% CI: [46.96, 99.99]Regression, Logistic

Secondary

Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

Time frame: Week 12

Population: All randomized participants who received at least one dose of study drug and had baseline who had baseline Itch NRS ≥4.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4	8.1 percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4	76.6 percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4	78.4 percentage of participants

p-value: <0.00195% CI: [13.68, 99.99]Regression, Logistic

p-value: <0.00195% CI: [15.09, 99.99]Regression, Logistic

Secondary

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)

The sPGA is the physician's determination of the participant's 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 assessed as 0, indicates complete resolution of plaque Ps.

Time frame: Week 12

Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)	0.0 Percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)	35.6 Percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)	36.4 Percentage of participants

Secondary

Percentage of Participants With Anti-Ixekizumab Antibodies

Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.

Time frame: Baseline through Week 12

Population: All randomized participants who received at least one dose of study drug.

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants With Anti-Ixekizumab Antibodies	0 percentage of participants
Ixekizumab 80mg Q4W	Percentage of Participants With Anti-Ixekizumab Antibodies	19 percentage of participants
Ixekizumab 80mg Q2W	Percentage of Participants With Anti-Ixekizumab Antibodies	12.5 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026

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

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Study design

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Secondary

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Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement

Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement

Change From Baseline on Patient Global Assessment of Disease Severity

Change From Baseline on the Joint Pain Visual Analog Scale (VAS)

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)

Percentage of Participants With Anti-Ixekizumab Antibodies