VitiligoPhase 3NCT06109649
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
A Phase 3 study testing Afamelanotide and NB-UVB Light and NB-UVB Light in people with Vitiligo, run by Clinuvel, Inc. at 30 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Afamelanotide and NB-UVB Light and NB-UVB Light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 11 Oct 2023to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States25 sites
CLINUVEL site
Alpharetta, Georgia, 00000
CLINUVEL site
Augusta, Georgia, 00000
CLINUVEL site
Baton Rouge, Louisiana, 00000
CLINUVEL site
Birmingham, Alabama, 00000
CLINUVEL Site
Cedar Park, Texas, 00000
CLINUVEL Site
Charleston, South Carolina, 00000
CLINUVEL site
Charlottesville, Virginia, 00000
CLINUVEL site
Chicago, Illinois, 00000
CLINUVEL site
Cleveland, Ohio, 00000
CLINUVEL site
Dallas, Texas, 00000
CLINUVEL site
Detroit, Michigan, 00000
CLINUVEL site
Fresno, California, 00000
CLINUVEL Site
Lee's Summit, Missouri, 00000
CLINUVEL site
Los Angeles, California, 00000
CLINUVEL site
Miami, Florida, 00000
CLINUVEL site
Minneapolis, Minnesota, 00000
CLINUVEL site
Miramar, Florida, 00000
CLINUVEL site
Palo Alto, California, 00000
CLINUVEL site
Philadelphia, Pennsylvania, 00000
CLINUVEL site
Rochester, New York, 00000
CLINUVEL site
Roseville, Minnesota, 00000
CLINUVEL site
San Diego, California, 00000
CLINUVEL site
Thompson's Station, Tennessee, 00000
CLINUVEL site
Tyler, Texas, 00000
CLINUVEL Site
Washington D.C., District of Columbia, 00000
About this study
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
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.
- Conditions
- Vitiligo
- Being tested
- Afamelanotide and NB-UVB Light, NB-UVB Light
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afamelanotide and NB-UVB LightDrug
Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
NB-UVB LightProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Afamelanotide and NB-UVB Light | Experimental | Not described Receives: Drug: Afamelanotide and NB-UVB Light |
| NB-UVB Light | Other | Not described Receives: Procedure: NB-UVB Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to Day 140
Secondary outcomes (9)
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)
Measured: From baseline to first documented occurrence of TVASI25, assessed up to Day 140
Time to onset of repigmentation of face
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline to Day 308
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start11 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinuvel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109649
- Sponsor's protocol ID
- CUV105
- Status last verified
- Feb 2025
- First submitted
- 20 Oct 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06109649
- Acronym / sponsor ID
- CUV105
- Conditions
- Vitiligo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinuvel, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afamelanotide and NB-UVB Light | Experimental | Drug: Afamelanotide and NB-UVB Light |
| NB-UVB Light | Other | Procedure: NB-UVB Light |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afamelanotide and NB-UVB LightPatients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks. | Drug | Afamelanotide and NB-UVB Light |
| NB-UVB LightPatients 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. | Procedure or surgery | NB-UVB Light |
Primary outcome
Percentage of patients achieving T-VASI 50 on the body
Time frame: 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).
9 secondary outcomes
Time to onset of repigmentation of full body
Time frame: From baseline to first documented occurrence of TVASI25, assessed up to Day 140
Time to onset of repigmentation of face
Time frame: From baseline to first documented occurrence of FVASI25, assessed up to Day 140
Percentage of patients achieving VASI 50 on the face
Time frame: From baseline to Day 140
Percentage of patients maintaining VASI 50 on body surface area excluding hands and feet
Time frame: From Day 140 to 308
Percentage of patients maintaining VASI 50 on facial lesions
Time frame: From Day 140 to 308
Percentage of patients achieving VASI 25/75/90 on the body
Time frame: From baseline to Day 140
Percentage of patients achieving VASI 25/75/90 on the face
Time frame: From baseline to Day 140
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Time frame: From baseline to Day 308
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
Time frame: From baseline to Day 308
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afamelanotide and NB-UVB Light and NB-UVB Light in people with Vitiligo, run by Clinuvel, Inc. at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, France, United Kingdom, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving T-VASI 50 on the body (time frame: From baseline to Day 140). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.