Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Afamelanotide; Placebo
Intervention MeSH terms: Afamelanotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Two-Arm, Randomized, Double-Blind Study and a Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants plus Narrow-Band Ultraviolet B (NBUVB) Light Source in the Treatment of Nonsegmental Vitiligo.
Masking: Double (Participant, Investigator)
Masking description: In the first half of the study, the Participant and Investigator are masked. In the second half of the study, the study is single arm, Open Label Study.
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility 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