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: July 11, 2014
Last verified: July 2014
  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
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
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: 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: July 11, 2014
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 July 22, 2014