An Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s Phenomenon Secondary to Systemic Sclerosis

Camurus AB0 个研究点目标入组 12 人开始时间: 2019年12月18日最近更新: 2021年1月5日

适应症

试验速览

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•Patients with a diagnosis of systemic sclerosis, as defined by 2013 American College of Rheumatology (ACR) criteria / European League against Rheumatism (EULAR) criteria.
•Patients with Raynaud’s phenomenon secondary to systemic sclerosis with a minimum of 5 Raynaud’s phenomenon attacks per week.
•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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Presence of active digital tip ulceration that has developed within 4 weeks before the Screening Visit. Active digital tip ulceration is defined by 1) visible loss of epithelial integrity or 2) an ulcer covered with eschar which is associated with ongoing moderate pain. Chronic ulcers with overlying eschar but with absent to mild pain are considered eligible.
•A variability of more than ±20% between 2 assessments of thermography which are separated by at least 3 hours at the Screening Visit.

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