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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01777191
First received: January 24, 2013
Last updated: April 20, 2016
Last verified: April 2016
  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) by Drug Delivery Device [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

  • PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.


Secondary Outcome Measures:
  • PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

  • PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.

  • PK: Cmax by Body Weight [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).

  • PK: AUC 0-tlast by Body Weight [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ] [ Designated as safety issue: No ]
    AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).

  • Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): 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 ]
    PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.

  • Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): 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 ]
    The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

  • Percentage of Participants With a Static Physician Global Assessment (sPGA) (0) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

  • Percentage of Device Operation Failures [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.

  • Percentage of Participants With Anti-Ixekizumab Antibodies [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

  • SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree"). 1 represents "Strongly Disagree" while 7 represents "Strongly Agree". The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit.


Enrollment: 204
Study Start Date: March 2013
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 every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).
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 Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.
Drug: Ixekizumab Prefilled Syringe
Administered SC by prefilled syringe
Other Name: LY2439821

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Results First Received: April 20, 2016
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2016