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

• ClinicalTrials.gov Identifier: NCT01382589
• Recruitment Status: Completed
• First Posted: June 27, 2011
• Last Update Posted: March 22, 2013
• Sponsor: Clinuvel Pharmaceuticals Limited
• Information provided by (Responsible Party): Clinuvel Pharmaceuticals Limited

Tracking Information

• First Submitted Date: June 7, 2011
• First Posted Date: June 27, 2011
• Last Update Posted Date: March 22, 2013
• Study Start Date: September 2011
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 24, 2011)

To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo [ Time Frame: 6 months ]

Time to onset of repigmentation of full body, face, trunk and extremities Pigmentation by VASI and VETF Maintenance of pigmentation Dermatology Life Quality Index (DLQI) Safety of the treatment will be assessed by: For selected study sites, immunomodulatory assessment Full body anterior and posterior photography Vitiligo lesion photography Examination of the skin and oral mucosa and digital photography Ophthalmologic examination

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 24, 2011): Maintenance of pigmentation achieved [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
• Official Title: A Phase II Randomised Pilot Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
• Brief Summary: The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).

Detailed Description

The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). The earliest described function of alpha-MSH is its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation. Vitiligo is the most common depigmentation disorder. Interventions in the treatment of vitiligo include phototherapy with narrow-band (NB) ultraviolet B (UVB) irradiation (NB-UVB).

The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Vitiligo

Intervention

• Drug: Afamelanotide
  NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation
  Other Name: CUV1647
• Device: NB-UVB
  NB-UVB light therapy 3-times per week, for total of 72 treatments

Study Arms

• Experimental: Arm A: Afamelanotide + NB-UVB
  Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)
  Intervention: Drug: Afamelanotide
• Active Comparator: Arm B: NB-UVB alone
  Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)
  Intervention: Device: NB-UVB

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2013): 15
• Original Estimated Enrollment (submitted: June 24, 2011): 120
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• 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
• Aged 18 or more
• Fitzpatrick skin types III-VI
• Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
• Providing written Informed Consent prior to the performance of any study-specific procedure

Exclusion criteria:

• Fitzpatrick skin types I-II
• Vitiligo involving the hands and feet only
• Extensive leukotrichia, in the opinion of the Investigator
• Vitiligo of more than 5 years duration
• 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
• Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit
• History of photosensitivity disorders
• Claustrophobia
• History of photosensitive lupus
• Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
• History of melanoma or lentigo maligna
• History of dysplastic nevus syndrome
• Any malignant skin lesions
• Any skin disease that may interfere with the study evaluation
• Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator
• 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 (confirmed by positive β-HCG pregnancy test) or lactating
• Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) during the trial and for a period of three months thereafter
• Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of three months hereafter
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01382589
• Other Study ID Numbers: CUV101
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Clinuvel Pharmaceuticals Limited
• Study Sponsor: Clinuvel Pharmaceuticals Limited
• Collaborators: Not Provided

Investigators

• Principal Investigator: Giovanni Leone, MD; San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY

• PRS Account: Clinuvel Pharmaceuticals Limited
• Verification Date: March 2013