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

NCT ID: NCT05159752

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-10-31

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.

Conditions

Xeroderma Pigmentosum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afamelanotide

Group Type: EXPERIMENTAL

Afamelanotide

Intervention Type: DRUG

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

Interventions

Afamelanotide

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinuvel Europe Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CLINUVEL investigative site

Regensburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Head of Clinical Operations

Role: CONTACT

mail@clinuvel.com

+441372860765

Facility Contacts

Head of Clinical Operations

Role: primary

mail@clinuvel.com

Other Identifiers

CUV156

Identifier Type: -

Identifier Source: org_study_id