A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN)

Amgen Inc.0 个研究点目标入组 60 人开始时间: 2021年2月11日最近更新: 2021年4月5日

试验速览

暂无简介。

•1. Male or Female subjects 2 to less than 18 years of age at randomization.
•2. Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
•3. Oral ulcers that occurred more or equal to 3 times within the 12-month period prior to the screening visit.
•4. Subject must have more or equal to 2 oral ulcers at both the screening visit and on day 1.
•5. Subject has had prior treatment with = 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.
•6. Subject is a candidate for systemic therapy for the treatment of oral ulcers.
•Other protocol-defined inclusion criteria apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Behçet’s disease-related active major organ involvement – pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and CNS (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
•- Previous major organ involvement is allowed if it occurred =1 year prior to the screening visit and is not active at time of enrollment;
•-Subjects with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed;
•- Subjects with BD-related arthritis and BD-skin manifestations are also allowed.
•2. Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).
•3. History or evidence of any other clinically significant disorder,
•condition or disease that could pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
•4. Female subject who is (or plans to become) pregnant or
•breastfeeding.
•5. Female subject of childbearing potential unwilling to use 1 highly
•effective method of contraception.
•Other protocol-defined exclusion criteria apply.

发起方

Amgen Inc.