Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis (UNCOVER-A)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01777191
First received: January 24, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Condition Intervention Phase
Plaque Psoriasis
Drug: Ixekizumab Auto-Injector
Drug: Ixekizumab Prefilled Syringe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector 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:
  • Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ixekizumab After Starting Dose [ Time Frame: Day 2 to Day 14 ] [ Designated as safety issue: No ]
  • PK: Area Under the Concentration Time Curve from Time 0 to 14 Days (AUC 0-14) of Ixekizumab [ Time Frame: Day 2 to Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of Ixekizumab in Participants with Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Efficacy of Ixekizumab in Participants with Moderate to Severe Plaque Psoriasis. Measure: static Physician Global Assessment (sPGA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Device Operation Failures [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
  • Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80 mg Ixekizumab Auto-Injector
Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection thereafter.
Drug: Ixekizumab Auto-Injector
Administered SC by auto-injector
Other Name: LY2439821
Experimental: 80 mg Ixekizumab Prefilled Syringe
Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection thereafter.
Drug: Ixekizumab Prefilled Syringe
Administered SC by prefilled syringe
Other Name: LY2439821

  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 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: NCT01777191

  Show 25 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: NCT01777191     History of Changes
Other Study ID Numbers: 14728, I1F-MC-RHBL
Study First Received: January 24, 2013
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014