Afamelanotide for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VitiligoAfamelanotide - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: From Baseline to Day 168

Day 168
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
Change in Quality of life using a vitiligo specific tool (C)
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
Day 84
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Proportion of participants achieving VASI25 on body surface area
Proportion of participants achieving VASI25 on facial lesions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Afamelanotide
45%Headache
34%Nausea
17%Nasopharyngitis
13%Influenza
13%Diarrhoea
12%Dizziness
12%Fatigue
11%Back pain
9%Abdominal pain
8%Vomiting
8%Implant site pain
8%Implant site haematoma
8%Flushing
7%Abdominal pain upper
7%Upper respiratory tract infection
7%Pyrexia
7%Migraine
7%Haematoma
5%Oedema peripheral
5%Cough
4%Toothache
4%Oropharyngeal pain
1%Spinal fracture
1%Thrombocytopenia
1%Cholelithiasis
1%Dysmenorrhoea
This histogram enumerates side effects from a completed 2009 Phase 3 trial (NCT04053270) in the Afamelanotide ARM group. Side effects include: Headache with 45%, Nausea with 34%, Nasopharyngitis with 17%, Influenza with 13%, Diarrhoea with 13%.

Trial Design

1 Treatment Group

Afamelanotide
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Afamelanotide · No Placebo Group · Phase 2

Afamelanotide
Drug
Experimental Group · 1 Intervention: Afamelanotide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afamelanotide
2014
Completed Phase 3
~510

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to day 168

Who is running the clinical trial?

Clinuvel, Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 75 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.
You have stable face vitiligo with F-VASI of at least 0.25.