A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

Condition(s) studied

Investigational drug(s) / intervention(s)

Afamelanotide and NB-UVB Light: Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.

NB-UVB Light: Patients will receive NB-UVB light twice per week for 20 weeks. Upon study completion, NB-UVB Light Arm participants will have the opportunity to enroll in an open-label extension phase of the study. In this extension phase, participants will undergo the same evaluations and assessments as the ones performed in the main part of the study under Afamelanotide and NB-UVB Light Arm.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percentage of patients achieving T-VASI 50 on the body — 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).

Trial sites (30)

Other trials for the same condition