A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)

NCTNCT05159752Other idCUV156

Open at ClinicalTrials.govAsk about this trial

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: 1 country
Germany
Start: 19 Oct 2021
Primary completion: Mar 2024 (estimated)
Completion: Oct 2024 (estimated)
First posted: 16 Dec 2021
Last update posted: 18 Jun 2023
Conditions: Xeroderma Pigmentosum

Timeline

1 trial

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

20212022202320242025

Ph 2
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)
NCT05159752
19 Oct 2021 to est. Oct 2024

Registry summary

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

The CUV156 study will evaluate the safety of afamelanotide in XP-C 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 outcomes1

Outcomes the sponsor listed as primary.

Change in minimal erythema dose (MED).
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(7)

Change in UV-induced DNA damage and repair capacity.
Time frame · From Baseline to Day 76.
Registry description
Analysis of UV photoproducts and DNA repair mechanisms.
Change in skin disease severity (A).
Time frame · From Baseline to Day 238.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity (B).
Time frame · From Baseline to Day 238.
Registry description
The higher the score, the more severe the disease.
Change in skin disease severity (C).
Time frame · From Baseline to Day 238.
Registry description
The higher the score, the more severe the disease.
Change in dermal melanin density.
Time frame · From Baseline to Day 238.
Registry description
Non-invasive quantitative skin reflectance measurement.
Change in quality of life assessed by a disease specific tool (A)
Time frame · From Baseline to Day 238.
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)
Time frame · From Baseline to Day 238.
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; * 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; * Female who is pregnant (confirmed by positive urine beta-Human chorionic gonadotropin pregnancy test) or lactating; * Females of child-bearing potential (pre-menopausal, not surgically sterile) not using highly effective contraceptive measures with a failure rate of less than 1% per year when used consistently and correctly (i.e. oral contraceptives, intrauterine device) or a life-style excluding pregnancy, for up to three months after the last implant administration; * Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who is not using highly effective contraceptive measures, as described above; * Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit; * Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit.

PepBank is a research reference. Talk to a doctor before you use any peptide.