Clinical trial NCT06109649: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Vitiligo
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients achieving T-VASI 50 on the body
timeFrame: From baseline to Day 140
Secondary outcomes:
measure: Time to onset of repigmentation of full body
timeFrame: From baseline to first documented occurrence of TVASI25, assessed up to Day 140
measure: Time to onset of repigmentation of face
timeFrame: From baseline to first documented occurrence of FVASI25, assessed up to Day 140
measure: Percentage of patients achieving VASI 50 on the face
timeFrame: From baseline to Day 140
measure: Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet
timeFrame: From Day 140 to 308
measure: Percentage of patients maintaining VASI 50 on facial lesions
timeFrame: From Day 140 to 308
measure: Percentage of patients achieving VASI 25/75/90 on the body
timeFrame: From baseline to Day 140
measure: Percentage of patients achieving VASI 25/75/90 on the face
timeFrame: From baseline to Day 140
measure: Percentage change in pigmentation on body surface area measured by the VASI scoring system
timeFrame: From baseline to Day 308
measure: Percentage change in pigmentation on facial surface area measured by the VASI scoring system
timeFrame: From baseline to Day 308
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CLINUVEL site
state: Alabama
city: Fresno
country: United States
facility: CLINUVEL site
state: California
city: Los Angeles
country: United States
facility: CLINUVEL site
state: California
city: Palo Alto
country: United States
facility: CLINUVEL site
state: California
city: San Diego
country: United States
facility: CLINUVEL site
state: California
city: Washington, D.C.
country: United States
facility: CLINUVEL Site
state: District of Columbia
city: Miami
country: United States
facility: CLINUVEL site
state: Florida
city: Miramar
country: United States
facility: CLINUVEL site
state: Florida
city: Alpharetta
country: United States
facility: CLINUVEL site
state: Georgia
city: Augusta
country: United States
facility: CLINUVEL site
state: Georgia
city: Chicago
country: United States
facility: CLINUVEL site
state: Illinois
city: Baton Rouge
country: United States
facility: CLINUVEL site
state: Louisiana
city: Detroit
country: United States
facility: CLINUVEL site
state: Michigan
city: Minneapolis
country: United States
facility: CLINUVEL site
state: Minnesota
city: Roseville
country: United States
facility: CLINUVEL site
state: Minnesota
city: Lee's Summit
country: United States
facility: CLINUVEL Site
state: Missouri
city: Rochester
country: United States
facility: CLINUVEL site
state: New York
city: Cleveland
country: United States
facility: CLINUVEL site
state: Ohio
city: Philadelphia
country: United States
facility: CLINUVEL site
state: Pennsylvania
city: Charleston
country: United States
facility: CLINUVEL Site
state: South Carolina
city: Thompson's Station
country: United States
facility: CLINUVEL site
state: Tennessee
city: Cedar Park
country: United States
facility: CLINUVEL Site
state: Texas
city: Dallas
country: United States
facility: CLINUVEL site
state: Texas
city: Tyler
country: United States
facility: CLINUVEL site
state: Texas
city: Charlottesville
country: United States
facility: CLINUVEL site
state: Virginia
city: La Réunion
country: France
facility: CLINUVEL site
city: Nice
country: France
facility: CLINUVEL site
city: Nairobi
country: Kenya
facility: CLINUVEL site
city: London
country: United Kingdom
facility: CLINUVEL site
city: Manchester
country: United Kingdom
facility: CLINUVEL site
Study officials:
References: