NCT06109649进行中（未招募）3 期
A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percentage of patients achieving T-VASI 50 on the body
研究概览
简要总结
The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1
- •Stable or active vitiligo
- •Aged 12 or more
- •Fitzpatrick skin types III-VI
排除标准
- •Fitzpatrick skin types I-II
- •Extensive leukotrichia
- •Treatment with NB-UVB phototherapy in the last three months prior to study start
- •Allergy to afamelanotide or the polymer contained in the implant
- •Any other treatment for vitiligo within 30 days prior to the Screening Visit
- •History of melanoma or lentigo maligna
- •History of dysplastic nevus syndrome
- •Any malignant skin lesions
- •Presence of severe hepatic disease or hepatic impairment
- •Female who is pregnant or lactating
- •Female of child-bearing potential 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 prior and concomitant therapy which may interfere with the objective of the study
- •Extensive tattoos
研究组 & 干预措施
Afamelanotide and NB-UVB Light
Experimental
干预措施: Afamelanotide and NB-UVB Light (Drug)
NB-UVB Light
Other
干预措施: NB-UVB Light (Procedure)
结局指标
主要结局
Percentage of patients achieving T-VASI 50 on the body
时间窗: From baseline to Day 140
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
次要结局
- Time to onset of repigmentation of full body(From baseline to first documented occurrence of TVASI25, assessed up to Day 140)
- Time to onset of repigmentation of face(From baseline to first documented occurrence of FVASI25, assessed up to Day 140)
- Percentage of patients achieving VASI 50 on the face(From baseline to Day 140)
- Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet(From Day 140 to 308)
- Percentage of patients maintaining VASI 50 on facial lesions(From Day 140 to 308)
- Percentage of patients achieving VASI 25/75/90 on the body(From baseline to Day 140)
- Percentage of patients achieving VASI 25/75/90 on the face(From baseline to Day 140)
- Percentage change in pigmentation on body surface area measured by the VASI scoring system(From baseline to Day 308)
- Percentage change in pigmentation on facial surface area measured by the VASI scoring system(From baseline to Day 308)
研究者
研究点 (2)
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