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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Afamelanotide and NB-UVB Light
* Procedure: NB-UVB Light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3 Stable or active vitiligo Aged 12 or more Fitzpatrick skin types IV-VI Exclusion Criteria: Fitzpatrick skin types I-III 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 four weeks 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afamelanotide and NB-UVB Light<br> | Drug: Afamelanotide and NB-UVB Light<br>* Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.<br>|
| Other: NB-UVB Light<br> | Procedure: NB-UVB Light<br>* Patients will receive NB-UVB light twice per week for 20 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving VASI50 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of repigmentation of full body | Measured using Total (T)-VASI25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100). | From day 0 to day 140 | 
| Time to onset of repigmentation of face | Measured using Face (F)-VASI25. A decrease in VASI indicates a reduction of the total body surface area affected by vitiligo (possible range 1-100). | From day 0 to day 140 | 
| Percentage of patients achieving VASI50 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 VASI50 on body surface area | 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 VASI50 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 VASI25/75/90 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 VASI25/75/90 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 |