A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01474512
First received: November 15, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: 80mg LY2439821 Dosing Regimen
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 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Static Physician Global Assessment (sPGA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Static Physician Global Assessment (sPGA) [ Time Frame: Baseline through Week 60 ] [ Designated as safety issue: No ]
  • Efficacy of LY2439821 in subjects with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (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: 1296
Study Start Date: November 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80 mg LY2439821 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: 80mg LY2439821 Dosing Regimen
Administered SC
Experimental: 80 mg LY2439821 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: 80mg LY2439821 Dosing Regimen
Administered SC
Experimental: 80 mg LY2439821 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: 80mg LY2439821 Dosing Regimen
Administered SC
Placebo Comparator: Placebo
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.
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474512

  Show 104 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: NCT01474512     History of Changes
Other Study ID Numbers: 12972, I1F-MC-RHAZ
Study First Received: November 15, 2011
Last Updated: May 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014