JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05159752

Studienbeginn:
Oktober 2021

Letztes Update:
18.06.2023

Wirkstoff:
Afamelanotide

Indikation (Clinical Trials):
Xeroderma Pigmentosum, Ichthyosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Clinuvel Europe Limited

Collaborator:
-

Kontakt

Head of Clinical Operations
Kontakt:
Phone: +441372860765
E-Mail: mail@clinuvel.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

CLINUVEL investigative site
Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Head of Clinical Operations
E-Mail: mail@clinuvel.com» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Change in minimal erythema dose (MED). (Time Frame - From Baseline to Day 76.):
MED is the lowest dose of UV light that causes reddening of the skin.

Secondary outcome:

1. Change in UV-induced DNA damage and repair capacity. (Time Frame - From Baseline to Day 76.):
Analysis of UV photoproducts and DNA repair mechanisms.

2. Change in skin disease severity (A). (Time Frame - From Baseline to Day 238.):
The higher the score, the more severe the disease.

3. Change in skin disease severity (B). (Time Frame - From Baseline to Day 238.):
The higher the score, the more severe the disease.

4. Change in skin disease severity (C). (Time Frame - From Baseline to Day 238.):
The higher the score, the more severe the disease.

5. Change in dermal melanin density. (Time Frame - From Baseline to Day 238.):
Non-invasive quantitative skin reflectance measurement.

6. Change in quality of life assessed by a disease specific tool (A) (Time Frame - From Baseline to Day 238.):
Higher scores represent worse health-related quality of life.

7. Change in quality of life assessed by a validated global quality of life tool (B) (Time Frame - From Baseline to Day 238.):
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.

Geprüfte Regime

Afamelanotide:
Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

Quelle: ClinicalTrials.gov

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