Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)

• Status: Completed
• Trial end date: 2016-06-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelanotide is expected to increase the rate of the repigmentation induced by NB-UVB, leading to a reduced frequency and dose of NB-UVB.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinuvel Pharmaceuticals Limited
• Treatments: Afamelanotide

Criteria

Inclusion Criteria:

• for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement

• for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement

• Vitiligo involving the head and neck

• Stable or slowly progressive vitiligo over a 3-month period

• Aged 21 years or more

• Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator

• Provided written Informed Consent prior to the performance of any study-specific procedure

Exclusion Criteria:

• Extensive leukotrichia, in the opinion of the Investigator

• Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit

• Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator

• Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit

• 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 photosensitivity disorders

• Claustrophobia

• Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator

• Any current skin disease that may have interfered with the study evaluation

• Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating

• Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced

• Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above

• Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit