Vitiligo
Conditions
Brief 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.
Interventions
DRUGAfamelanotide and NB-UVB Light
Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
PROCEDURENB-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.
Sponsors
Clinuvel, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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 types I-II * Extensive leukotrichia * Treatment with NB-UVB phototherapy in the last three months prior to study start * Allergy to afamelanotide or the polymer contained in the implant * Any other treatment for vitiligo within 30 days prior to the Screening Visit * History of melanoma or lentigo maligna * History of dysplastic nevus syndrome * Any malignant skin lesions * Presence of severe hepatic disease or hepatic impairment * Female who is pregnant or lactating * Female of child-bearing potential not using adequate contraceptive measures * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures * Use of any prior and concomitant therapy which may interfere with the objective of the study * Extensive tattoos
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of repigmentation of face | From baseline to first documented occurrence of FVASI25, assessed up to Day 140 | 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). |
| Percentage of patients achieving VASI 50 on the face | From baseline to Day 140 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet | From Day 140 to 308 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Percentage of patients maintaining VASI 50 on facial lesions | From Day 140 to 308 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Time to onset of repigmentation of full body | From baseline to first documented occurrence of TVASI25, assessed up to Day 140 | 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) |
| Percentage of patients achieving VASI 25/75/90 on the face | From baseline to Day 140 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Percentage change in pigmentation on body surface area measured by the VASI scoring system | From baseline to Day 308 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Percentage change in pigmentation on facial surface area measured by the VASI scoring system | From baseline to Day 308 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
| Percentage of patients achieving VASI 25/75/90 on the body | From baseline to Day 140 | Measured using VASI. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100). |
Countries
France, Kenya, United Kingdom, United States
Outcome results
None listed