Phase 3
Completed N=162
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment
Source: ClinicalTrials.gov NCT02634801 ↗Enrolled (actual)
162
Serious AEs
4.6%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 — 90.7; 22.2; 70.4 Percentage of Participants — p=<.0001
◆ Published Evidence
Established
43citations · ~7 / year
A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment.
Summary
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
Linked Publications
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A 24-week multicentre, randomized, open-label, parallel-group study comparing the efficacy and safety of ixekizumab vs. fumaric acid esters and methotrexate in patients with moderate-to-severe plaque psoriasis naive to systemic treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 |
90.7; 22.2; 70.4 | <.0001 sig |
| SECONDARY Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline |
79.6; 9.3; 38.9 | — |
| SECONDARY Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline |
40.7; 3.7; 13.0 | — |
| SECONDARY Change From Baseline in PASI Total Score |
-16.68; -4.93; -14.61 | — |
| SECONDARY 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 |
86.5; 13.2; 51.9 | — |
| SECONDARY Percentage of Participants Achieving DLQI (0,1) |
63.0; 14.8; 37.0 | — |
| SECONDARY Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score |
-13.08; -5.37; -12.81 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis |
-20.64; -5.26; -18.46 | — |
| SECONDARY Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score |
-7.23; -2.45; -3.77 | — |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score |
-20.85; -6.76; -18.56 | — |
| SECONDARY Patient Benefit Index (PBI) Overall Benefit Score |
3.42; 2.33; 2.66 | — |
| SECONDARY Change From Baseline on Itch Numeric Rating Scale (NRS) Score |
-5.25; -1.50; -4.40 | — |
| SECONDARY Change From Baseline on the Skin Pain Visual Analog Scale (VAS) |
-33.83; -7.20; -28.29 | — |
| SECONDARY Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16) |
-2.16; -1.01; -2.50 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) |
4.45; 0.57; 4.01 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores |
7.13; 3.39; 6.99 | — |
| SECONDARY Change From Baseline on Patient's Global Assessment (PatGA) of Disease Severity |
-3.12; -0.87; -2.39 | — |
| SECONDARY Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score |
-19.87; -5.18; -15.05 | — |
| SECONDARY Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score |
-6.58; -0.14; -3.41 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score |
0.15; 0.04; 0.15 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Psoriasis (PSO) Index Score |
0.15; 0.05; 0.13 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Visual Analog Scale Score |
16.91; 6.08; 13.91 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score |
3.08; -1.26; 0.06 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score |
-22.70; -5.29; -20.32 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work |
-28.23; -3.45; -23.57 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score |
-18.20; -6.20; -19.80 | — |
| SECONDARY Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question |
81.8; 26.5; 66.7 | — |
| SECONDARY Percentage of Participants Positive Responses to Genital Psoriasis Question |
85.0; 29.2; 75.0 | — |
| SECONDARY Mean Adherence on Medication and Satisfaction With Therapy (STAQ) |
2.84; 2.75; 2.78; 2.82; 2.00; 2.43 | — |
Eligibility Criteria
Inclusion Criteria
- Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.
- Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis.
- Have a (PASI score >10 or BSA >10) and DLQI >10 at screening and at baseline.
Exclusion Criteria
- Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
- Have received systemic nonbiologic psoriasis therapy.
- Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
- Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
- Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
- Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
- Have had a serious infection or are immunocompromised.
- At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.
Data sourced from ClinicalTrials.gov (NCT02634801) 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.