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

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

  Purpose

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.
ConditionInterventionPhase
Plaque PsoriasisDrug: Ixekizumab Drug: PlaceboPhase 3
Study Type:Interventional
Study Design:Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title:Multicenter, 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
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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)
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
  • Change from Baseline on the Children’s Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the CDLQI
  • Change from Baseline on the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the DLQI
  • 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) in Case of Scalp or Hand/Feet Involvement [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the PPASI in case of scalp or hand/feet involvement
  • 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)
Estimated Enrollment:195
Actual Study Start Date:March 28, 2017
Estimated Study Completion Date:February 3, 2021
Estimated Primary Completion Date:April 3, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixekizumab

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

Administered SC
Other Name: LY2439821
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
Other Name: LY2439821

Drug: Placebo

Administered SC

About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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