Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afamelanotide and NB-UVB Light · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Afamelanotide and NB-UVB Light | EXPERIMENTAL | - |
| NB-UVB Light | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Afamelanotide and NB-UVB Light | DRUG | Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks. |
| NB-UVB Light | PROCEDURE | 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. |
Inclusion Criteria: * 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 Exclusion Criteria: * Fitzpatrick skin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 5 | PHASE3 | Povorcitinib |
| Pfizer Inc. | PFE | 2 | PHASE3 | Ritlecitinib |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | GIA632 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE2 | Roflumilast 0.3% foam |
| Forte Biosciences Inc. | FBRX | 1 | PHASE1 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE1 | TEV-53408 |
Afamelanotide is being evaluated for vitiligo and as a skin DNA repair therapy in healthy volunteers. In vitiligo, it is studied in combination with narrow-band ultraviolet (NB-UVB) light. It is also being assessed for its capacity to repair ultraviolet radiation-induced DNA damage in healthy volunteers.
Afamelanotide is a small molecule being studied for its effects on skin DNA repair and vitiligo. It is evaluated for its capacity to repair ultraviolet radiation-induced DNA damage. The specific molecular target is not disclosed in the available information.
Afamelanotide is developed by Clinuvel Pharmaceuticals Limited, which trades under the ticker CUVL. The company is conducting clinical trials for this drug in dermatology, focusing on vitiligo and skin DNA repair.
Afamelanotide is in Phase 1 clinical development. One Phase 1 trial has been completed, and a Phase 3 trial is active but not recruiting. The drug is investigational and has not been approved by regulatory authorities.
Afamelanotide has two clinical trials. NCT05368857 is a completed Phase 1 study on DNA repair capacity in healthy volunteers in the United Kingdom. NCT06109649 is an active Phase 3 study comparing SCENESSE and NB-UVB light versus NB-UVB light alone in vitiligo patients across the US, France, Kenya, and the UK.
Afamelanotide is also known as SCENESSE, as indicated in the Phase 3 trial title. The trial compares SCENESSE and NB-UVB light versus NB-UVB light alone in vitiligo patients, confirming that SCENESSE is the brand name for Afamelanotide.