A phase 2, 12-week, randomized, double-blind, placebo-controlled study of DS-1211b in individuals with pseudoxanthoma elasticum - DS1211-A-U201

Daiichi Sankyo, Inc0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1. Sign and date the ICF prior to the start of any study-specific qualification
•procedures.
•2. Are male or female participants aged 18 to 75 years at screening.
•3. Have an established diagnosis of PXE, with typical ocular and dermatological
•clinical features:
•a. Ocular findings - angioid streaks or peau d*orange
•b. Skin findings - characteristic PXE papules and plaques or diagnostic
•histopathological changes in lesional skin
•4. Are fully vaccinated for coronavirus disease 2019 (COVID-19) per current
•Center for Disease Control and Prevention guidelines
•5. For women of childbearing potential (not postmenopausal as a result of
•either natural or postsurgery cessation of menses), must have a negative serum
•pregnancy test at screening and must be willing to use an effective method of
•birth control, as detailed in Section 17.1.2 of the protocol upon entering
•study screening, during the treatment period, and up until the time of the
•follow-up visit.
•6. Are willing and able to comply with scheduled visits, drug administration
•laboratory tests, other study procedures, and study restrictions.

•1. Have a history of bone fracture in the past 6 months.
•2. Have a history of active metabolic bone disease that significantly affect
•the interpretation of study biomarker results, excluding osteopenia or
•osteoporosis without fragility fracture.
•3. Have a history of calcium pyrophosphate deposit disease such as
•chondrocalcinosis, pseudogout, and pyrophosphate arthropathy.
•4. Have a history of hypophosphatasia.
•5. Have a history of untreated hyperparathyroidism.
•6. Participated in another interventional research study in the past 60 days.
•7. Are participating or have participated within the last 12 months in PXE
•trials (eg, trials with PPi, PPi analogues such as bisphosphonate, or ENPP1 and
•its analogues) or in clinical trials relating to bone mineralization.

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