Phase 3
Completed N=91
A Study in Japanese Participants With Moderate-to-Severe Psoriasis
Source: ClinicalTrials.gov NCT01624233 ↗Enrolled (actual)
91
Serious AEs
4.9%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) — 98.7 percentage of participants
◆ Published Evidence
Highly cited
132citations · ~12 / year
Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis.
Summary
This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.
Linked Publications (2)
-
Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis.
-
Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) |
98.7 | — |
| SECONDARY Percentage of Participants Achieving ≥75% Improvement in PASI |
95.9; 92.3 | — |
| SECONDARY Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab |
9.63; 3.48 | — |
| SECONDARY Number of Participants With Anti-Ixekizumab Antibodies |
10; 0; 0 | — |
| SECONDARY Percent of Participants Achieving PASI 90% and 100% Improvement |
83.3; 32.1; 90.5; 48.6; 80.8; 48.7 | — |
| SECONDARY Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) |
89.7; 89.2; 83.3; 35.9; 51.4; 52.6 | — |
| SECONDARY Change From Baseline in Percent of Body Surface Area (BSA) Involvement |
-38.3; -41.2; -40.8 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
-7.7; -20.5; -23.4 | — |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) |
-24.8; -24.9; -23.3 | — |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] |
-1.1; -1.6; -1.4 | — |
| SECONDARY Change From Baseline in Itch Numeric Rating Scale (NRS) Score |
-4.7; -4.8; -4.8 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
-9.2; -9.2; -9.6 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] |
4; 4; 5 | — |
| SECONDARY Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) |
-47.3; -51.0 | — |
| SECONDARY Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement |
7.5; 3.0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With sPGA (0 or 1) and sPGA (0) |
4.5; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Percent of BSA Involvement |
-24.7; -40.2 | — |
| SECONDARY Change From Baseline in NAPSI |
-16.8; -21.4 | — |
| SECONDARY Change From Baseline in PSSI |
-8.5; -23.2 | — |
| SECONDARY Change From Baseline in QIDS-SR16 Score |
-0.5; -1.8 | — |
| SECONDARY Change From Baseline in Itch NRS Score |
-1.1; -4.9 | — |
| SECONDARY Change From Baseline in DLQI Score |
-2.3; -8.9 | — |
| SECONDARY Change From Baseline in Participants Assessment of Joint Pain VAS |
-12.8; -43.8 | — |
| SECONDARY Number of Participants Achieving ACR20 |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men must agree to use a reliable method of birth control during the study
- Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Candidates for phototherapy and/or systemic therapy
- Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
- At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
- Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis
Exclusion Criteria
- History of drug-induced psoriasis
- Concurrent or recent use of any biologic agent
- Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
- Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
Data sourced from ClinicalTrials.gov (NCT01624233) 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.