A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis - BE CONNECTED

CB Biopharma SR0 个研究点目标入组 40 人开始时间: 2021年5月20日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Participant must be =12 to <18 years of age at the time of signing the informed consent/assent according to local regulation
•-Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and:
•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
•d) 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
•-Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy
•-Body weight =30 kg and body mass index for age percentile of =5 at Baseline
•-Male or female
•A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance
•-Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•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

•-Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
•-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
•-Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
•-Participant has laboratory abnormalities at Screening
•-Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier
•-Presence of active suicidal ideation, or positive suicide behavior
•-Participant has been diagnosed with severe depression in the past 6 months

发起方

CB Biopharma SR