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Clinical Trials/NCT05210582
NCT05210582RecruitingPhase 2

An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the Face

Clinuvel, Inc.1 site in 1 country6 target enrollmentStarted: October 11, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
6
Locations
1
Primary Endpoint
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male and female patients with a confirmed diagnosis of vitiligo on the face and with T-VASI range 0.5-50%
  • •Stable face vitiligo with F-VASI of at least 0.1%
  • •Stable or slowly progressive vitiligo over a 3-month period
  • •Fitzpatrick skin types IV-VI
  • •Treatment with narrowband (NB)-UVB light 2-3 times per week during the last four weeks preceding the first implant for priming

Exclusion Criteria

  • •Patients with segmental vitiligo
  • •Fitzpatrick skin types I-III
  • •Treatment with NB-UVB phototherapy in the last three months prior to phototherapy, excluding the sessions for priming in the four weeks prior to treatment. A 3-month washout period from phototherapy is necessary prior to priming.
  • •Previous topical treatment for vitiligo
  • •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 melanoma or lentigo maligna
  • •Any current skin disease that may interfere with the study evaluation
  • •Presence of severe hepatic disease or hepatic impairment
  • •Renal impairment
  • •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 or lactating
  • •Female of child-bearing potential not using adequate contraceptive measures during the treatment phase and for a period of three months thereafter
  • •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above
  • •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
  • •Use of any other prior and concomitant therapy which may interfere with the objective of the study
  • •Subjects assessed as not suitable for the study in the opinion of the Investigator

Arms & Interventions

Afamelanotide

Experimental

Intervention: Afamelanotide (Drug)

Outcomes

Primary Outcomes

Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions

Time Frame: From Baseline to Day 84

Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100)

Secondary Outcomes

  • Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area(From Baseline to Day 84)
  • Change in Quality of life using a vitiligo specific tool (C)(From Baseline to Day 168)
  • Percentage change in pigmentation on body surface area measured by the VASI scoring system(From Baseline to Day 84)
  • Percentage change in pigmentation on facial surface area measured by the VASI scoring system(From Baseline to Day 168)
  • Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)(From Baseline to Day 168)
  • Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)(From Baseline to Day 168)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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