Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments ixekizumab, ustekinumab
Phase phase 3
Target IL-12
Sponsor Eli Lilly and Company
Start date October 2015
End date May 2016
Trial size 300 participants
Trial identifier NCT02561806, 16012, 2015-000892-28, I1F-MC-RHBS

Summary

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
ixekizumab LY2439821
Administered SC
(Active Comparator)
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
ustekinumab
Administered SC

Primary Outcomes

Measure
Proportion of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline
time frame: Week 12

Secondary Outcomes

Measure
Proportion of Participants with a ≥75% Improvement in PASI (PASI 75) from Baseline
time frame: Week 12
Proportion of Participants with a 100% Improvement of PASI (PASI 100) from Baseline
time frame: Week 12
Proportion of Participants with a Static Physician Global Assessment (sPGA) (0,1) with at Least a 2-Point Improvement from Baseline
time frame: Week 12
Proportion of Participants with a sPGA (0) Remission
time frame: Week 12
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis
time frame: Baseline, Week 12
Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
time frame: Baseline, Week 12
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
time frame: Baseline, Week 12
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
time frame: Baseline, Week 12
Change from Baseline in Itch Numeric Rating Scale (NRS)
time frame: Baseline, Week 12
Change from Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
time frame: Baseline, Week 12
Proportion of Participants with Dermatology Life Quality Index (DLQI) (0,1)
time frame: Week 12
Change from Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression and HADS Anxiety Subscales
time frame: Baseline, Week 12
Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
time frame: Baseline, Week 12
Change from Baseline on Patient Global Assessment of Disease Severity
time frame: Baseline, Week 12
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 12
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
time frame: Baseline, Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic plaque psoriasis for at least 6 months before baseline - Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy) - PASI score at least 10 at screening and at baseline - Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment Exclusion Criteria: - Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study - Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline - Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline - Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists - Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study - Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study - Have a known allergy or hypersensitivity to latex - Have had any major surgery within 8 weeks of baseline or will require such during the study - Have active or history of malignant disease within 5 years prior to baseline - Significant uncontrolled disorder - Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline - Are women who are lactating or breast-feeding

Additional Information

Official title A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.