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

NCT04525157 | Completed Phase 2 Results

• 1 other identifier: CUV103
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)

  A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)

  From Day 0 to Day 196

Study Arms (3)

Afamelanotide and NB-UVB

EXPERIMENTAL

Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

Drug: Afamelanotide

Placebo and NB-UVB

PLACEBO COMPARATOR

Participants received Placebo implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

Drug: Placebo

Single-Arm, Open Label Group

EXPERIMENTAL

The study design was modified into a single-arm, open label study with only one treatment group receiving afamelanotide implants plus NB-UVB light. Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).

Drug: Afamelanotide

Interventions

Afamelanotide DRUG

Afamelanotide and NB-UVB; Single-Arm, Open Label Group

Placebo DRUG

Placebo and NB-UVB

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

MeSH Terms

Conditions

Vitiligo

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: CLINUVEL PHARMACEUTICALS LTD

mail@clinuvel.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 25, 2020
• Study Start: June 6, 2014
• Primary Completion: February 2, 2016
• Study Completion: June 6, 2016
• Last Updated: September 22, 2023
• Results First Posted: May 21, 2021

Record last verified: 2023-09