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: September 29, 2014
Last verified: September 2014

November 15, 2011
September 29, 2014
November 2011
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01474512 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: 80mg LY2439821 Dosing Regimen
    Administered SC
  • Drug: Placebo
    Administered SC
  • 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.
    Intervention: Drug: 80mg LY2439821 Dosing Regimen
  • 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.
    Intervention: Drug: 80mg LY2439821 Dosing Regimen
  • 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.
    Intervention: Drug: 80mg LY2439821 Dosing Regimen
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1296
April 2018
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   Australia,   United Kingdom,   Denmark,   Germany,   Hungary,   Italy,   Japan,   Poland,   Romania
 
NCT01474512
12972, I1F-MC-RHAZ
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP