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 not accepting patients for this trial.

Lead Sponsor:

Eli Lilly and Company

Stanford Investigator(s):

Intervention(s):

  • Drug: Etanercept
  • 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: Participants of childbearing age or childbearing potential who are
   sexually active who test negative for pregnancy must be counseled and agree to use
   either 1 highly effective method of contraception or 2 acceptable methods of
   contraception combined for the duration of the study and for at least 12 weeks
   following the last dose of study drug, or remain abstinent during the study and for at
   least 12 weeks following the last dose of study drug.

   - 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 unless ruled out by biopsy.

   - Have used any therapeutic agent targeted at reducing interleukin-17.

   - Have received other therapies within the specified time frames prior to screening (see
   below):

      - adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any
      other biologic disease-modifying antirheumatic drug 5 half-lives.

      - 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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia Tafoya, MPH
650-724-1982
Not Recruiting