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

Primary Purpose

Vitiligo

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Afamelanotide

Placebo

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Afamelanotide and NB-UVB

Placebo and NB-UVB

Single-Arm, Open Label Group

Arm Description

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

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

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04525157

First Posted

August 6, 2020

Last Updated

September 20, 2023

Sponsor

Clinuvel Pharmaceuticals Limited

1. Study Identification

Unique Protocol Identification Number

NCT04525157

Brief Title

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

Official Title

A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo 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 (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 6, 2014 (Actual)

Primary Completion Date

February 2, 2016 (Actual)

Study Completion Date

June 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinuvel Pharmaceuticals Limited

4. Oversight

5. Study Description

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.

Detailed Description

Vitiligo is the most common depigmentation disorder. A commonly used treatment is phototherapy with narrow-band ultraviolet B 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). Afamelanotide activates melanin in skin, with the controlled-release injectable implant formulation having an affect across the total body surface area (pandermally). Earlier studies in vitiligo patients showed afamelanotide, in combination with NB-UVB, could induce faster and deeper repigmentation in patients compared to NB-UVB alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Afamelanotide and NB-UVB

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo and NB-UVB

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Single-Arm, Open Label Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Afamelanotide

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

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)

Time Frame

From Day 0 to Day 196

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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