A Phase 3, Multicenter, Randomized, Double-Blind Study with an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

CB Biopharma SPR0 个研究点目标入组 450 人开始时间: 2018年2月19日最近更新: 2020年4月14日

适应症

试验速览

暂无简介。

•- Must be at least 18 years of age
•- Chronic plaque PSO for at least 6 months prior to the Screening Visit
•- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale
•- Subject is a candidate for systemic PSO therapy
•- Female subject of child bearing potential must be willing to use highly effective method of contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 390
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab
•- Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
•- Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
•- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
•- Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
•- Subject has had previous exposure to adalimumab
•- Presence of active suicidal ideation or severe depression
•- Subject has concurrent or a recent history (<5 years) of malignancy

发起方

CB Biopharma SPR