Clinuvel’s vitiligo program – trial participation
Recently, the biopharmaceutical company Clinuvel announced that it would commence a clinical trial of a new drug for vitiligo. The company has received significant interest in its program and answers to many common questions can be found at www.clinuvel.com/vitiligo.
Please note that directly contacting Clinuvel to participate in this trial may jeopardise your ability to participate in this, or future trials for vitiligo.
Clinuvel is sponsoring a clinical trial of its drug SCENESSE® (afamelanotide) in six expert vitiligo centers globally; three each in the USA and Europe. Up to 20 (twenty) patients will be enrolled in the study at each study site. Each of these centers will enroll patients from their existing patient populations first, before taking general enquiries.
This trial is the first in Clinuvel’s INSPIRE (International SCENESSE® Pilot Repigmentation Evaluation) program and has been given the clinical name CUV101.
If you are interested in participating in the CUV101 clinical trial, please read the following document and contact your treating dermatologist or physician first, asking them whether they believe you are a good candidate to participate in clinical trials. Sharing this document with your dermatologist or physician will assist them in making this evaluation.
The study design
CUV101 is a multi-centre six-month open label pilot study to evaluate the efficacy of SCENESSE® as a combination therapy with narrowband ultraviolet B (NB-UVB) phototherapy compared to NB-UVB alone. NBUVB clinically administered thrice per week over 18 months is considered the standard of care in nonsegmental vitiligo to prevent the progression of lesions and stimulate repigmentation in depigmented skin.
SCENESSE® will be administered every 28 days to 50 percent of the trial patients. All trial patients will be treated with NB-UVB thrice weekly for six months (72 treatments total) and repigmentation and maintenance of pigmentation will be evaluated using the internationally recognised Vitiligo Area Scoring Index (VASI) and Vitiligo European Task Force (VETF) evaluation system. Overall results between the group treated with SCENESSE®
and the NB-UVB only group will then be compared. For six months following the completion of the dosing each patient will attend three clinical visits to allow long term comparison of the repigmentation effects of the two treatments.
Inclusion and exclusion criteria
The goal of the CUV101 study is to determine SCENESSE’s ability to repigment skin in an initial pilot population of individuals with nonsegmental vitiligo. To do this, strict criteria have been placed on individuals who can and can’t participate in the trial. No exceptions can or will be made to these criteria to facilitate trial participation.
- Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total
body surface involvement
- Stable or slowly progressive vitiligo over a 3-month period
- Patients previously untreated with any kind of light therapy (including NB-UVB)
- Aged 18 or more
- Fitzpatrick skin types III-VI
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- Vitiligo involving the hands and feet only or of more than 5 years duration
- Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo
within four weeks prior to the Screening Visit
- Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
- Any skin disease that may interfere with the study evaluation
- Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
- Use of any prior and concomitant therapy which may interfere with the objective of the study, including
drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit
- Subjects assessed as not suitable for the study in the opinion of the Investigator
Trial participants will need to be able to attend clinical visits three times a week for six months and several follow up visits in a further six months to be considered for this trial. Due to these time commitments, participants must be living within commuting distance of the clinics in Detroit, Los Angeles, New York, Nice, Rome or Zürich.
If you believe you satisfy all the above requirements, please discuss this document with your dermatologist or
physician who can contact Clinuvel for more information on trial participation via the email address