VitiligoPhase 2NCT05210582
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
A Phase 2 study testing Afamelanotide in people with Vitiligo, run by Clinuvel, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Afamelanotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CLINUVEL Investigational site
Detroit, Michigan, 48202
About this study
Official title: An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face
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.
- Conditions
- Vitiligo
- Being tested
- Afamelanotide
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfamelanotideDrug
Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.
| Study group | Role | What they receive |
|---|---|---|
| Afamelanotide | Experimental | Not described Receives: Drug: Afamelanotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
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)
Measured: From Baseline to Day 84
Secondary outcomes (6)
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area
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).
Measured: From Baseline to Day 84
Percentage change in pigmentation on body surface area measured by the VASI scoring system
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)
Measured: From Baseline to Day 84
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)
Measured: From Baseline to Day 168
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
The higher the score, the more severe the disease
Measured: From Baseline to Day 168
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Higher the value means lower noticeability
Measured: From Baseline to Day 168
Change in Quality of life using a vitiligo specific tool (C)
Higher value means a lower quality of life
Measured: From Baseline to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start11 Oct 2022
- Primary completionApr 2023 (estimated)
- Study completionAug 2023 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT05210582
- Sponsor's protocol ID
- CUV104
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face
- ClinicalTrials.gov ID
- NCT05210582
- Acronym / sponsor ID
- CUV104
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Clinuvel, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 27 Jan 2022 (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 CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afamelanotide | Experimental | Drug: Afamelanotide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| AfamelanotidePatients will receive afamelanotide over a three-month period, with an additional three-month follow up. | Drug | Afamelanotide |
Primary outcome
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Time frame: 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)
6 secondary outcomes
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area
Time frame: From Baseline to Day 84
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Time frame: From Baseline to Day 84
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
Time frame: From Baseline to Day 168
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
Time frame: From Baseline to Day 168
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Time frame: From Baseline to Day 168
Change in Quality of life using a vitiligo specific tool (C)
Time frame: From Baseline to Day 168
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afamelanotide in people with Vitiligo, run by Clinuvel, Inc. at 1 site in United States.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Operations (+441372860765, mail@clinuvel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions (time frame: From Baseline to Day 84). 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 9 Feb 2023.