NCT05370235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 C and V (XPC and XPV)
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) in patients with XP-C.
研究概览
简要总结
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V 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 or XP-V;
- •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;
- •Existing melanoma;
- •Female who is pregnant or lactating;
- •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
- •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
- •Use of any other prior and concomitant therapy which may interfere with the objective of the study;
- •Participation in a clinical trial for an investigational agent.
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) in patients with XP-C.
时间窗: From baseline to day 76.
MED is the lowest dose of UV light that causes reddening of the skin.
Change in MED in patients with XP-V.
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
- Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C.(From baseline to day 76.)
- Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C.(From baseline to day 76.)
- Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V.(From baseline to day 76.)
- Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V.(From baseline to day 76.)
- Change in skin disease severity in patients with XP-C (A).(From baseline to day 76.)
- Change in skin disease severity in patients with XP-V (A)(From baseline to day 76.)
- Change in skin disease severity in patients with XP-C (B).(From baseline to day 76.)
- Change in skin disease severity in patients with XP-V (B).(From baseline to day 76.)
- Change in skin disease severity in patients with XP-C (C).(From baseline to day 76.)
- Change in skin disease severity in patients with XP-V (C).(From baseline to day 76.)
- Change in quality of life assessed by a disease specific tool (A) in patients with XP-C.(From baseline to day 76.)
- Change in quality of life assessed by a disease specific tool (A) in patients with XP-V.(From baseline to day 76.)
- Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-C.(From baseline to day 76.)
- Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-V.(From baseline to day 76.)
研究者
研究点 (1)
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