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

Eli Lilly and Company0 个研究点目标入组 201 人开始时间: 2017年5月23日最近更新: 2021年5月3日

试验速览

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•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 195
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

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