Phase 3
Completed N=438
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03364309 ↗Enrolled (actual)
438
Serious AEs
2.4%
Results posted
Jun 2021
Primary outcomePrimary: 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; 79.9; 86.4 Percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
6citations · ~6 / year
Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab.
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.
Linked Publications (2)
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Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab.
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Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
3.4; 79.9; 86.4 | <0.0001 sig |
| PRIMARY Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) |
8.0; 87.4; 93.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission) |
0.0; 35.6; 36.4 | — |
| SECONDARY Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) |
2.3; 75.9; 82.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) |
0.0; 29.3; 33.0 | — |
| SECONDARY 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; 76.6; 78.4 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score |
0.92; -8.60; -8.86 | <0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement |
-1.26; -11.35; -10.07 | <0.001 sig |
| SECONDARY Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis |
-0.36; -35.32; -36.70 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement |
-1.59; -18.33; -19.52 | <0.001 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score |
-1.812; 4.417; 4.724 | <0.001 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score |
-1.233; 3.960; 4.129 | <0.001 sig |
| SECONDARY Change From Baseline on Patient Global Assessment of Disease Severity |
-0.5; -3.1; -3.1 | <0.001 sig |
| SECONDARY Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement |
-2.99; -6.34; -7.78 | 0.003 sig |
| SECONDARY Change From Baseline on the Joint Pain Visual Analog Scale (VAS) |
-12.2; -39.6; -37.4 | 0.022 sig |
| SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies |
0; 19; 12.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03364309) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.