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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01597245
First received: May 10, 2012
Last updated: September 15, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 118 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: September 15, 2014
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 September 22, 2014