CUV102: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

Sponsor

Clinuvel Pharmaceuticals Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01430195

Collaborator

(none)

Enrollment

Locations

Arms

17.1

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: Afamelanotide Procedure: Narrow-Band UVB Light Treatment	Phase 1

Detailed Description

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). Further therapeutic approaches are desired and currently being evaluated. 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Proof of Concept Study to Compare Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Nonsegmental Vitiligo

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afamelanotide + NB-UVB: Experimental Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).	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 Other Names: CUV1647
Active Comparator: NB-UVB alone: Active Comparator Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).	Procedure: Narrow-Band UVB Light Treatment To be administered 3 times/week for 6 months. 72 treatments in total. Other Names: NB-UVB light treatment

Arm

Intervention/Treatment

Experimental: Afamelanotide + NB-UVB: Experimental

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).

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

Other Names:

CUV1647

Active Comparator: NB-UVB alone: Active Comparator

Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).

Procedure: Narrow-Band UVB Light Treatment

To be administered 3 times/week for 6 months. 72 treatments in total.

Other Names:

NB-UVB light treatment

Outcome Measures

Primary Outcome Measures

Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores [6 months]

Secondary Outcome Measures

Time to onset of repigmentation of full body, face, trunk and extremities [6 months]
Quality of life using the Dermatology Life Quality Index (DLQI) [6 months]
Vitiligo biopsies assessments (optional, selected sites only) [6 months]
Short term safety of both treatments: Routine laboratory assessments - Full body anterior and posterior photography - Vitiligo lesion photography - Examination of the skin and oral mucosa and digital photography - Ophthalmologic examination [6 months]
Maintenance of pigmentation using the VASI and VETF scores [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects with a confirmed diagnosis 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
Previous treatment with NB-UVB within 6 months prior to the Screening Visit
Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anesthetic 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), are 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