A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENT FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS - PS0021

CB Biopharma0 个研究点目标入组 168 人开始时间: 2024年3月21日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Study participant must be 6 to <18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation - Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit - Study participant meets the following at both the Screening and Baseline Visits: •a) Body surface area (BSA) affected by PSO =10% •b). Investigator's Global Assessment (IGA) score =3 (on a scale from 0 to 4) •c). Psoriasis Area and Severity Index (PASI) score =12 OR PASI score =10 plus at least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement - Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling - Study participant has body weight =15 kg and body mass index for age percentile of =5 at Screening

•- Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 - Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO - Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD - History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated - Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) - Study participant has previously received bimekizumab - Study participant has previously received ustekinumab - Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments - Study participant has the presence of active suicidal ideation, or positive suicide behavior - Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded - Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study

发起方

CB Biopharma