NL-OMON38804已完成2 期
A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis - DOSARA
ARAIM Pharmaceuticals0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The subjects will have to present the following criteria:
- •Established diagnosis of sarcoidosis with both of the following two criteria:
- •1) Score of 4 or greater on Brief Pain Inventory *average pain* questions (BPI; 0 (least discomfort)-10 (worst discomfort))
- •2) Discomfort defined as distal pain/discomfort plus one of the following: 1) dysesthesia, 2) burning/painful feet worsening at night, or 3) intolerance of sheets or clothes touching the legs or feet
- •AND either of the following two criteria
- •1) Corneal nerve fiber density reduced compared to normal (i.e., greater than 1 standard deviation less than the mean of a normative population)
- •2) A previous skin biopsy (obtained within the prior 2 years) showing a reduced intraepidermal nerve fiber density ((i.e., greater than 1 standard deviation less than the mean of a normal age and gender relevant population);In addition, subjects must:
- •* Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff
- •* Be willing to comply with study restrictions
- •* Be willing to check in with the study center via the telephone
- •* Between 18 and 70 years of age (inclusive)
- •* Body Mass Index (BMI) < 40 kg/m2 (inclusive)
- •* If female of childbearing potential, a negative urine pregnancy test at screening and acceptable contraception will be maintained during the screening and dosing period and 1 month beyond. Acceptable contraception consists of hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject*s usual menstrual cycle period) before study entry, intrauterine device (IUD), or double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- •* Able to complete self-administered questionnaires (RAND-36, SFNSL, BPI, COMPASS-31, FAS, NPSI)
- •* Refrigerator and freezer at home for storage of study medication.
排除标准
- •The subjects should not present any of the following criteria:
- •* Medical history of clinically relevant physical and mental health condition other than conditions related to sarcoidosis, as judged by the investigator
- •* Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to sarcoidosis or could interfere with conduct of 6-minute walk assessment (as judged by the investigator)
- •* Other medical conditions known to be associated with small nerve fiber loss, except for diabetes in good control (as judged by the investigator)
- •Known clinically relevant abnormalities in ECG (as judged by the investigator)
- •* Illicit drug abuse or excessive alcohol consumption (as judged by the investigator)
- •* History of serious malignancy within the last 5 years other than a basal cell or squamous cell carcinoma that has been removed
- •* History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food (as judged by the investigator)
- •* Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening.
- •* Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- •* Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times in the calendar year preceding study enrollment
- •* Inadequate venous accessibility as judged by clinicians (physician or nurse)
- •* Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration)
- •* If female, pregnant or breast-feeding
- •* Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject
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