A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

NCTNCT05370235Other idCUV152

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Overview

Status: Status unknown
Phase: Phase 2
Enrollment: 6 participants (estimated)
Sponsor: Clinuvel Europe Limited · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 2 countries
Belgium, Spain
Start: 28 Mar 2022
Primary completion: Jun 2024 (estimated)
Completion: Dec 2024 (estimated)
First posted: 11 May 2022
Last update posted: 21 Sept 2023
Conditions: Xeroderma Pigmentosum

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 2
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
NCT05370235
28 Mar 2022 to est. Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.

Interventions

AfamelanotideDrug

Arms1

Experimental
Afamelanotide

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in minimal erythema dose (MED) in patients with XP-C.
Time frame · From baseline to day 76.
Registry description
MED is the lowest dose of UV light that causes reddening of the skin.
Change in MED in patients with XP-V.
Time frame · From baseline to day 76.
Registry description
MED is the lowest dose of UV light that causes reddening of the skin.

Secondary outcomes(14)

Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C.
Time frame · From baseline to day 76.
Registry description
Analysis of UV photoproducts from skin samples.
Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C.
Time frame · From baseline to day 76.
Registry description
Analysis of DNA repair mechanisms from skin samples.
Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V.
Time frame · From baseline to day 76.
Registry description
Analysis of UV photoproducts from skin samples.
Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V.
Time frame · From baseline to day 76.
Registry description
Analysis of DNA repair mechanisms from skin samples.
Change in skin disease severity in patients with XP-C (A).
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity in patients with XP-V (A)
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity in patients with XP-C (B).
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity in patients with XP-V (B).
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity in patients with XP-C (C).
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity in patients with XP-V (C).
Time frame · From baseline to day 76.
Registry description
The higher the score, the more severe the disease.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-C.
Time frame · From baseline to day 76.
Registry description
Higher scores represent worse health-related quality of life.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-V.
Time frame · From baseline to day 76.
Registry description
Higher scores represent worse health-related quality of life.
Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-C.
Time frame · From baseline to day 76.
Registry description
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.
Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-V.
Time frame · From baseline to day 76.
Registry description
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V; * Aged 18-75 years. Exclusion Criteria: * Known allergy to afamelanotide or the polymer contained in the implant; * Presence of severe hepatic disease or hepatic impairment; * Renal impairment; * Any other medical condition which may interfere with the study protocol; * Existing melanoma; * Female who is pregnant or lactating; * Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures; * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures; * Use of any other prior and concomitant therapy which may interfere with the objective of the study; * Participation in a clinical trial for an investigational agent.

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