A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelanotide is expected to increase the rate of the repigmentation induced by NB-UVB, leading to a reduced frequency and dose of NB-UVB.
详细描述
Vitiligo is the most common depigmentation disorder. A commonly used treatment is phototherapy with narrow-band ultraviolet B irradiation (NB-UVB). Further therapeutic approaches are desired and currently being evaluated. The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). Afamelanotide activates melanin in skin, with the controlled-release injectable implant formulation having an affect across the total body surface area (pandermally). Earlier studies in vitiligo patients showed afamelanotide, in combination with NB-UVB, could induce faster and deeper repigmentation in patients compared to NB-UVB alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
In the first half of the study, the Participant and Investigator are masked. In the second half of the study, the study is single arm, Open Label Study.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement
- •for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement
- •Vitiligo involving the head and neck
- •Stable or slowly progressive vitiligo over a 3-month period
- •Aged 21 years or more
- •Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator
- •Provided written Informed Consent prior to the performance of any study-specific procedure
排除标准
- •Extensive leukotrichia, in the opinion of the Investigator
- •Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit
- •Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
- •Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit
- •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 photosensitivity disorders
- •Claustrophobia
- •Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
- •Any current skin disease that may have interfered with the study evaluation
- •Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating
- •Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced
- •Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above
- •Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
研究组 & 干预措施
Afamelanotide and NB-UVB
Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).
干预措施: Afamelanotide (Drug)
Placebo and NB-UVB
Participants received Placebo implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).
干预措施: Placebo (Drug)
Single-Arm, Open Label Group
The study design was modified into a single-arm, open label study with only one treatment group receiving afamelanotide implants plus NB-UVB light.
Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).
干预措施: Afamelanotide (Drug)
结局指标
主要结局
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
时间窗: From Day 0 to Day 196
A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)
次要结局
未报告次要终点