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Summary

for people ages 6–18 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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

Keywords

Plaque Psoriasis children psoriasis treatment adolescents

Eligibility

You can join if…

Open to people ages 6–18

  • 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, in the opinion of the investigator.

You CAN'T join if...

  • 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.

Locations

  • Stanford University Hospital not yet accepting patients
    Palo Alto, California, 94304, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT03073200
Phase
Phase 3
Lead Scientist
Tina Bhutani
Study Type
Interventional
Last Updated
July 1, 2017
I’m interested in this study!