Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments 80mg ly2439821 dosing regimen, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2011
End date June 2014
Trial size 1296 participants
Trial identifier NCT01474512, 12972, I1F-MC-RHAZ

Summary

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3.
80mg ly2439821 dosing regimen
Administered SC
(Experimental)
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3.
80mg ly2439821 dosing regimen
Administered SC
(Experimental)
Dosing Regimen 3 is not used until Week 12. At Week 12, participants re-randomized to this arm will receive Dosing Regimen 3.
80mg ly2439821 dosing regimen
Administered SC
(Placebo Comparator)
Administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2.
placebo
Administered SC

Primary Outcomes

Measure
Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Static Physician Global Assessment (sPGA)
time frame: 12 weeks
Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: 12 weeks

Secondary Outcomes

Measure
Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Static Physician Global Assessment (sPGA)
time frame: Baseline through Week 60
Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: Baseline through Week 60
Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO)
time frame: Baseline through Week 60

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization - At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization - 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 randomization - Candidate for phototherapy and/or systemic therapy - 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 Exclusion Criteria: - Pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Clinically significant flare of psoriasis during the 12 weeks prior to randomization - 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 randomization - Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study - Have participated in any study with IL-17 antagonists, including LY2439821 - Serious disorder or illness other than plaque psoriasis - Serious infection within the last 3 months - Breastfeeding or nursing (lactating) women.

Additional Information

Official title A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.