A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis - BE BRIGHT

CB Biopharma SR0 个研究点目标入组 1,120 人开始时间: 2018年7月31日最近更新: 2024年1月15日

适应症

试验速览

暂无简介。

•- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
•- Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
•- Female subjects must be:
•a) Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
•b) Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
•salpingectomy)
•c) Or, if of childbearing potential (and engaged in sexual activity that
•could result in procreation), must be willing to use a highly effective
•method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014
•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 1020
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- Subject has previously participated in this study
•- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
•- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject’s entry into PS0014 although the decision on whether to enroll the subject remains with the investigator
•- Subject has a positive or indeterminate interferon gamma release
•assay (IGRA) in a feeder study, unless appropriately evaluated and
•- Subject must have a negative interferon gamma release assay (IGRA) as measured at the final dosing visit of the feeder study
•- Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
•- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

发起方

CB Biopharma SR