Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment 80 mg ixekizumab
Phase phase 3
Sponsor Eli Lilly and Company
Start date June 2012
End date September 2013
Trial size 90 participants
Trial identifier NCT01624233, 13976, I1F-JE-RHAT

Summary

This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 until Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.
80 mg ixekizumab LY2439821
Administered SC

Primary Outcomes

Measure
Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks

Secondary Outcomes

Measure
Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: static Physician Global Assessment (sPGA)
time frame: Baseline up to 292 weeks
Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: Baseline up to 292 weeks
Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO)
time frame: Baseline up to 292 weeks
Efficacy of ixekizumab in participants with psoriatic arthritis. Measure: Pain Visual Analog Scale (VAS)
time frame: Baseline up to 292 weeks
Efficacy of ixekizumab in participants with psoriatic arthritis. Measure: American College of Rheumatology 20 (ACR20)
time frame: Baseline up to 292 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.