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: September 29, 2014
Last verified: September 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: May 2015
Primary Completion Date: May 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
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: 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: September 29, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014