Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo; Etanercept
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Etanercept; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: children; psoriasis treatment; adolescents

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

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 Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global
             Assessment (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 counselled 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 paediatric authorities (e.g., the American Academy of
             Paediatrics). 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.