A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2) - Full Text View

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: 80 mg ixekizumab Dosing Regimen Drug: 50 mg etanercept Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: Static Physician Global Assessment (sPGA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: sPGA [ Time Frame: Baseline through Week 60 ] [ Designated as safety issue: No ]
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: PASI [ Time Frame: Baseline through Week 60 ] [ Designated as safety issue: No ]
Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline through Week 60 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1225
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 80 mg ixekizumab Dosing Regimen 1 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.	Drug: 80 mg ixekizumab Dosing Regimen Administered SC Other Name: LY2439821
Experimental: 80 mg ixekizumab Dosing Regimen 2 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.	Drug: 80 mg ixekizumab Dosing Regimen Administered SC Other Name: LY2439821
Experimental: 80 mg ixekizumab Dosing Regimen 3 Dosing Regimen 3 is not used until Week 12. At Week 12, participants re-randomized to this arm will receive Dosing Regimen 3.	Drug: 80 mg ixekizumab Dosing Regimen Administered SC Other Name: LY2439821
Active Comparator: 50 mg etanercept Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to placebo, or to Dosing Regimen 2.	Drug: 50 mg etanercept Administered SC
Placebo Comparator: Placebo Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to placebo or Dosing Regimen 2.	Drug: Placebo Administered SC

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
sPGA score of at least 3 and PASI score of at least 12 at screening and at first dose of study drug
Candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable 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
Prior use of etanercept
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
Concurrent or recent use of any biologic agent
Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) 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 interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than plaque psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597245

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 117 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01597245 History of Changes
Other Study ID Numbers:	12973, I1F-MC-RHBA
Study First Received:	May 10, 2012
Last Updated:	June 14, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Canada: Health Canada Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013