Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments fumaric acid esters, methotrexate, ixekizumab
Phase phase 3
Sponsor Eli Lilly and Company
Start date January 2016
End date November 2016
Trial size 162 participants
Trial identifier NCT02634801, 16190, 2015-002649-69, I1F-EW-RHBZ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
ixekizumab LY2439821
Administered SC
(Active Comparator)
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.
fumaric acid esters
Administered orally
ixekizumab LY2439821
Administered SC
(Active Comparator)
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.
methotrexate
Administered orally
ixekizumab LY2439821
Administered SC

Primary Outcomes

Measure
Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24
time frame: Week 24

Secondary Outcomes

Measure
Proportion of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline
time frame: Week 24
Proportion of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) from Baseline
time frame: Week 24
Proportion 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
time frame: Week 24
Change from Baseline on Dermatology Life Quality Index (DLQI) Total Score
time frame: Baseline, Week 24
Proportion of Participants Achieving DLQI (0,1)
time frame: Week 24
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
time frame: Baseline, Week 24
Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
time frame: Baseline, Week 24
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
time frame: Baseline, Week 24
Change from Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score
time frame: Baseline, Week 24
Patient Benefit Index (PBI)
time frame: Week 24
Change from Baseline on Itch Numeric Rating Scale (NRS)
time frame: Baseline, Week 24
Change from Baseline on the Skin Pain Visual Analog Scale (VAS)
time frame: Baseline, Week 24
Change from Baseline on Quick Inventory of Depressive Symptomatology- Self Report (16 items) (QIDS-SR16)
time frame: Baseline, Week 24
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
time frame: Baseline, Week 24
Change from Baseline on Patient's Global Assessment of Disease Severity
time frame: Baseline, Week 24
Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Index, EQ-5D Utility Index and VAS
time frame: Baseline, Week 24
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
time frame: Baseline, Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.