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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afamelanotide and NB-UVB Light | Experimental |
| |
| NB-UVB Light | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afamelanotide and NB-UVB Light | Drug | Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving T-VASI 50 on the body | 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). | From baseline to Day 140 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of repigmentation of full body | Measured using T-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100) | From baseline to first documented occurrence of TVASI25, assessed up to Day 140 |
| Time to onset of repigmentation of face |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINUVEL site | Birmingham | Alabama | 00000 | United States | ||
| CLINUVEL site |
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| 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. |
|
Measured using F-VASI 25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100). |
| From baseline to first documented occurrence of FVASI25, assessed up to Day 140 |
| Percentage of patients achieving VASI 50 on the face | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From baseline to Day 140 |
| Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From Day 140 to 308 |
| Percentage of patients maintaining VASI 50 on facial lesions | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From Day 140 to 308 |
| Percentage of patients achieving VASI 25/75/90 on the body | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From baseline to Day 140 |
| Percentage of patients achieving VASI 25/75/90 on the face | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From baseline to Day 140 |
| Percentage change in pigmentation on body surface area measured by the VASI scoring system | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From baseline to Day 308 |
| Percentage change in pigmentation on facial surface area measured by the VASI scoring system | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). | From baseline to Day 308 |
| Fresno |
| California |
| 00000 |
| United States |
| CLINUVEL site | Los Angeles | California | 00000 | United States |
| CLINUVEL site | Palo Alto | California | 00000 | United States |
| CLINUVEL site | San Diego | California | 00000 | United States |
| CLINUVEL Site | Washington D.C. | District of Columbia | 00000 | United States |
| CLINUVEL site | Miami | Florida | 00000 | United States |
| CLINUVEL site | Miramar | Florida | 00000 | United States |
| CLINUVEL site | Alpharetta | Georgia | 00000 | United States |
| CLINUVEL site | Augusta | Georgia | 00000 | United States |
| CLINUVEL site | Chicago | Illinois | 00000 | United States |
| CLINUVEL site | Baton Rouge | Louisiana | 00000 | United States |
| CLINUVEL site | Detroit | Michigan | 00000 | United States |
| CLINUVEL site | Minneapolis | Minnesota | 00000 | United States |
| CLINUVEL site | Roseville | Minnesota | 00000 | United States |
| CLINUVEL Site | Lee's Summit | Missouri | 00000 | United States |
| CLINUVEL site | Rochester | New York | 00000 | United States |
| CLINUVEL site | Cleveland | Ohio | 00000 | United States |
| CLINUVEL site | Philadelphia | Pennsylvania | 00000 | United States |
| CLINUVEL Site | Charleston | South Carolina | 00000 | United States |
| CLINUVEL site | Thompson's Station | Tennessee | 00000 | United States |
| CLINUVEL Site | Cedar Park | Texas | 00000 | United States |
| CLINUVEL site | Dallas | Texas | 00000 | United States |
| CLINUVEL site | Tyler | Texas | 00000 | United States |
| CLINUVEL site | Charlottesville | Virginia | 00000 | United States |
| CLINUVEL site | La RĂ©union | France |
| CLINUVEL site | Nice | France |
| CLINUVEL site | Nairobi | Kenya |
| CLINUVEL site | London | United Kingdom |
| CLINUVEL site | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C534526 | afamelanotide |
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