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 - I1F-MC-RHCD

Eli Lilly0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•- Males and females from 6 years to <18 years of age.
•- Have a diagnosis of moderate-to-severe plaque-type Ps for at least 6 months prior to baseline (Week 0; Visit 2), as determined by the investigator.
•- Have PASI score *12 and a sPGA *3 and body area involved *10% of whole body surface at screening (Visit 1) and baseline (Week 0; Visit 2).
•- Are candidates for phototherapy or systemic treatment of Ps (may be either naive or have a prior history of previous treatment) or have Ps considered by the investigator as poorly controlled with topical therapy.

•- Pustular, erythrodermic, and/or guttate forms of Ps or have drug induced psoriasis.
•- Have used any therapeutic agent targeted at reducing IL-17.
•- Previously treated with etanercept (Note: criteria applicable to all countries)
•- Concurrent or recent use of any biologic agent within the following washout periods: 1) Adalimumab and infliximab *60 days, abatacept >90 days, anakinra >7 days, or any other biologic DMARD >5 half-lives prior to baseline
•- Systemic therapy for Ps and PsA (other than above, eg, MTX, cyclosporine), phototherapy (eg, PUVA) in the previous 4 weeks; 2) Any investigational drugs in the previous 4 weeks or 5 half-lives, whichever is longer; 3) UVA-therapy, UVB-therapy; topical treatments (except in face, scalp, and genital area during screening) in the previous 4 weeks.
•- Have latent TB, active TB, acute or chronic viral hepatitis, active infection (within 4 weeks of baseline), history of immune deficiency syndrome, history of malignancy, History of major immunologic reaction, history of sepsis or risk of sepsis.

发起方