NCT05210582招募中2 期
An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face
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
- Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
研究概览
简要总结
The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.
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 and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
- •Stable face vitiligo with F-VASI of at least 0.1%
- •Stable or slowly progressive vitiligo over a 3-month period
- •Fitzpatrick skin types IV-VI
- •Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming
排除标准
- •Patients with segmental vitiligo
- •Fitzpatrick skin types I-III
- •Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
- •Previous topical treatment for vitiligo
- •Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant
- •History of melanoma or lentigo maligna
- •Any current skin disease that may interfere with the study evaluation
- •Presence of severe hepatic disease or hepatic impairment
- •Renal impairment
- •History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
- •Female who is pregnant or lactating
- •Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
- •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
- •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
- •Use of any other prior and concomitant therapy which may interfere with the objective of the study
- •Subjects assessed as not suitable for the study in the opinion of the Investigator
研究组 & 干预措施
Afamelanotide
Experimental
干预措施: Afamelanotide (Drug)
结局指标
主要结局
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
时间窗: From Baseline to Day 84
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100)
次要结局
- Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area(From Baseline to Day 84)
- Change in Quality of life using a vitiligo specific tool (C)(From Baseline to Day 168)
- Percentage change in pigmentation on body surface area measured by the VASI scoring system(From Baseline to Day 84)
- Percentage change in pigmentation on facial surface area measured by the VASI scoring system(From Baseline to Day 168)
- Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)(From Baseline to Day 168)
- Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)(From Baseline to Day 168)
研究者
研究点 (1)
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