Vitiligo
Conditions
Brief summary
The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.
Interventions
DRUGAfamelanotide
Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.
Sponsors
Clinuvel, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50% * Stable face vitiligo with F-VASI of at least 0.1% * Stable or slowly progressive vitiligo over a 3-month period * Fitzpatrick skin types IV-VI * Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming
Exclusion criteria
* Patients with segmental vitiligo * Fitzpatrick skin types I-III * Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming. * Previous topical treatment for vitiligo * Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant * History of melanoma or lentigo maligna * Any current skin disease that may interfere with the study evaluation * Presence of severe hepatic disease or hepatic impairment * Renal impairment * History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation * Female who is pregnant or lactating * Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above * Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit * Use of any other prior and concomitant therapy which may interfere with the objective of the study * Subjects assessed as not suitable for the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions | From Baseline to Day 84 | Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in pigmentation on body surface area measured by the VASI scoring system | From Baseline to Day 84 | Percentage change in pigmentation on body surface area (excluding hands and feet) measured by VASI scoring system. 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 168 | A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100) |
| Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area | From Baseline to Day 84 | Proportion of participants achieving VASI25 on body surface area (excluding hands and feet). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100). |
| Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B) | From Baseline to Day 168 | Higher the value means lower noticeability |
| Change in Quality of life using a vitiligo specific tool (C) | From Baseline to Day 168 | Higher value means a lower quality of life |
| Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A) | From Baseline to Day 168 | The higher the score, the more severe the disease |
Countries
United States
Contacts
Primary ContactHead of Clinical Operations
Outcome results
None listed