Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Eli Lilly and Company

Stanford Investigator(s):

Intervention(s):

  • Drug: Ixekizumab
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

6 Years - 17 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
650-724-1982
Recruiting