Phase III Vitiligo Study

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1008599

• Contact name

  Pilar Bilbao

• Contact email

  pilar.bilbao@clinuvel.com

• Sponsor organisation

  CLINUVEL, Inc.

• Research summary

  This study is designed to compare the efficacy and safety of SCENESSE® (afamelanotide) and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB light alone in the treatment of Vitiligo. Afamelanotide is known to help with skin pigmentation and protection against light and sun. It works in a similar way to a hormone (α-Melanocyte-stimulating hormone) in human's body. Till now, more than 1,000 patients have received afamelanotide without any unwanted safety issues . This study is for patients with a documented history of vitiligo. The study will be eligible for patients with generalized vitiligo on the face and body, who are aged 12 or more, have Fitzpatrick skin type IV-VI (medium to dark skin), do not have extensive white hair patches (leukotrichia), respond to NB-UVB treatment, do not have a history of melanoma, lentigo maligna or do not have any malignant (cancerous) skin lesions, do not have severe hepatic disease or hepatic impairment, are not pregnant or breastfeeding.
  Eligible participants will be assigned to one of two groups: NB-UVB light treatment in combination with the test drug (up to 100 participants) and NB-UVB light treatment alone (up to 100 participants). The computer system will allocate patients randomly to one of the groups.
  The participation will involve NB-UVB light treatment twice per week for 20 weeks (all participants) and 50% of patients will also receive an implant of afamelanotide every 3 weeks for 20 weeks. In total, they will attend up to 43 visits to the study site. During study visit various data will be collected and procedures performed including: demographic information, medical history, concomitant medication, general physical examination, blood and urine tests, vital signs, pregnancy test and vitiligo lesion photography. Additional tools will be used to assess effectiveness and impact: Quality of Life questionnaire, Patient Global Impression of Change and Perception of Vitiligo Severity.

• REC name

  HSC REC A

• REC reference

  23/NI/0125

• Date of REC Opinion

  7 Nov 2023

• REC opinion

  Further Information Favourable Opinion