Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments ixekizumab, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date August 2015
End date April 2017
Trial size 1227 participants
Trial identifier NCT02513550, 15988, 2015-000190-12, I1F-MC-RHBP

Summary

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with 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 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 50.
ixekizumab LY2439821
Administered SQ
(Experimental)
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 50. Placebo administered SQ, Q2W to maintain blind.
ixekizumab LY2439821
Administered SQ
placebo
Administered SQ
(Experimental)
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 50. Placebo administered SQ, Q2W to maintain blind.
ixekizumab LY2439821
Administered SQ
placebo
Administered SQ

Primary Outcomes

Measure
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
time frame: Week 52
Proportion of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
time frame: Week 52

Secondary Outcomes

Measure
Proportion of Participants Achieving sPGA (0)
time frame: Week 52
Proportion of Participants Achieving PASI 90 and PASI 100
time frame: Week 52
Mean Change and Mean Percent Improvement of PASI from Baseline
time frame: Baseline, Week 52
Mean Change from Baseline in Percent Body Surface Area (BSA) Involvement
time frame: Baseline, Week 52
Mean Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score
time frame: Baseline, Week 52
Mean Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score
time frame: Baseline, Week 52
Mean Change from Baseline in Palmoplantar PASI (PPASI)
time frame: Baseline, Week 52
Proportion of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 point Reduction from Baseline
time frame: Baseline, Week 52
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) total score of 0 and 1 (DLQI [0,1])
time frame: Week 52
Mean Change from Baseline in DLQI Total Score and Domains, Itch NRS score, and Skin Pain Visual Analog Scale (VAS)
time frame: Baseline, Week 52
Mean Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
time frame: Baseline, Week 52
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
time frame: Week 52
Number of Participants with Anti-Ixekizumab Antibodies
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Present with chronic plaque psoriasis for at least 6 months prior to enrollment - At least 10% BSA of psoriasis at screening and at enrollment - sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment - Candidates for phototherapy and/or systemic therapy - Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment Exclusion Criteria: - Predominant pattern of pustular, erythrodermic, 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 prior to enrollment and during the study - Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment - Concurrent or recent use of any biologic agent - Have participated in any study with ixekizumab - Received a live vaccination within 12 weeks prior to enrollment - Serious disorder or illness other than psoriasis - Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis - Major surgery within 8 weeks of baseline, or will require surgery during the study - Breastfeeding or nursing (lactating) women

Additional Information

Official title A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Description The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.