NCT05159752招募中2 期
A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in minimal erythema dose (MED).
研究概览
简要总结
The CUV156 study will evaluate the safety of afamelanotide in XP-C patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient with a molecular-genetically confirmed diagnosis of XP-C;
- •Aged 18-75 years.
排除标准
- •Known allergy to afamelanotide or the polymer contained in the implant;
- •Presence of severe hepatic disease or hepatic impairment;
- •Renal impairment;
- •Any other medical condition which may interfere with the study protocol;
- •Female who is pregnant (confirmed by positive urine beta-Human chorionic gonadotropin pregnancy test) or lactating;
- •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using highly effective contraceptive measures with a failure rate of less than 1% per year when used consistently and correctly (i.e. oral contraceptives, intrauterine device) or a life-style excluding pregnancy, for up to three months after the last implant administration;
- •Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using highly effective contraceptive measures, as described above;
- •Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit;
- •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit.
研究组 & 干预措施
Afamelanotide
Experimental
干预措施: Afamelanotide (Drug)
结局指标
主要结局
Change in minimal erythema dose (MED).
时间窗: From Baseline to Day 76.
MED is the lowest dose of UV light that causes reddening of the skin.
次要结局
- Change in skin disease severity (C).(From Baseline to Day 238.)
- Change in UV-induced DNA damage and repair capacity.(From Baseline to Day 76.)
- Change in skin disease severity (A).(From Baseline to Day 238.)
- Change in quality of life assessed by a disease specific tool (A)(From Baseline to Day 238.)
- Change in quality of life assessed by a validated global quality of life tool (B)(From Baseline to Day 238.)
- Change in skin disease severity (B).(From Baseline to Day 238.)
- Change in dermal melanin density.(From Baseline to Day 238.)
研究者
研究点 (1)
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