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.
Eli Lilly and Company
- Drug: Ixekizumab
- Drug: Placebo
- Drug: Etanercept
- 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
- 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.
- 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
- 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
- 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