Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

ID: NCT03073200
Status: Recruiting
Phase: Phase 3
Start Date: March 28, 2017
First Submitted: March 03, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: Argentina, Canada, Czechia, France, Germany, Hungary, Mexico, Netherlands, Poland, Puerto Rico, Russian Federation, Spain, United States
Conditions: Plaque Psoriasis
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Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Detailed Description

Condition or disease Intervention/treatment Phase

Plaque Psoriasis

Drug: Ixekizumab
Other Names
LY2439821
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateMarch 03, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateMarch 28, 2017
Anticipated Completion DateFebruary 03, 2021
Actual Primary Completion DateApril 03, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Time Frame: Week 12]

    Proportion of participants with a PASI 75

  • Proportion of Participants with a Static Physician Global Assessment (sPGA) (0,1) [Time Frame: Week 12]

    Proportion of participants with a sPGA (0,1)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Proportion of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [Time Frame: Week 12]

    Proportion of participants with a PASI 90

  • Proportion of Participants with a sPGA (0) [Time Frame: Week 12]

    Proportion of participants with a sPGA (0)

  • Proportion of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [Time Frame: Week 12]

    Proportion of participants with a PASI 100

  • Proportion of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Time Frame: Week 2]

    Proportion of participants with a PASI 75

  • Proportion of Participants with a Static Physician Global Assessment (sPGA) (0,1) [Time Frame: Week 2]

    Proportion of participants with a sPGA (0,1)

  • Proportion of Participants with an Improvement of ≥4 for those who had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4 [Time Frame: Week 12]

    Proportion of participants with an improvement of ≥4 for those who had a baseline itch NRS score of ≥4

  • Proportion of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1) [Time Frame: Week 12]

    Proportion of Participants Achieving CDLQI/DLQI (0/1)

  • Change from Baseline on the Nail Psoriasis Severity Index (NAPSI) [Time Frame: Baseline, Week 12]

    Change from baseline on the NAPSI

  • Change from Baseline on the Psoriasis Severity Index (PSSI) [Time Frame: Baseline, Week 12]

    Change from baseline on the PSSI

  • Change from Baseline on the Palmoplantar Psoriasis Severity Index (PPASI) [Time Frame: Baseline, Week 12]

    Change from baseline on the PPASI

  • Number of Participants with Anti-Ixekizumab Antibodies [Time Frame: Baseline through Week 48]

    Number of participants with anti-ixekizumab antibodies

  • Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) [Time Frame: Week 12]

    PK: Trough ixekizumab concentration at steady state (Ctrough ss)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Official TitleMulticenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
195
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Plaque Psoriasis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Ixekizumab

Administered SC

Other Names
LY2439821
Drug: Placebo

Administered SC

Other Names
Study Groups/Cohorts
Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.

Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.

Study Arms
Experimental Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
Drug : Ixekizumab
Administered SC

Placebo Comparator Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug : Ixekizumab
Administered SC

Placebo Comparator Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug : Placebo
Administered SC

Arm Intervention/Treatment
Experimental Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
Drug : Ixekizumab
Placebo Comparator Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug : Ixekizumab
Placebo Comparator Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Drug : Placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment195
Completion DateFebruary 03, 2021
Eligibility Criteria: Inclusion Criteria:
- Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
- Have PASI score ≥12 and a sPGA ≥3 and body surface area involvement ≥10% at screening and baseline.
- Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
- Male subjects agree to use a reliable method of birth control during the study.
- Female subjects are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of investigational product, whichever is longer.
- Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
- All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific pediatric authorities (e.g., the American Academy of Pediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

Exclusion Criteria:
- Have pustular, erythrodermic, and/or guttate forms of psoriasis.
- Have drug-induced psoriasis.
- Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
- Participants with a documented history of immune deficiency syndrome.
- Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
- Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Have used any therapeutic agent targeted at reducing interleukin-17.
- Have received other therapies within the specified timeframes below:
- adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives prior to baseline.
- systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.
GenderAll
Age6 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Argentina
Canada
Czechia
France
Germany
Hungary
Mexico
Netherlands
Poland
Puerto Rico
Russian Federation
Spain
United States
Czech Republic

Administrative Information

NCT Number:NCT03073200
Other Study ID Numbers
16367
I1F-MC-RHCD
2016-003331-38
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
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