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

September 20, 2023 updated by: Clinuvel Europe Limited

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Head of Clinical Operations
  • Phone Number: +441372860765
  • Email: mail@clinuvel.com

Study Locations

  • Belgium
      • Clinuvel Investigational Site, Belgium
        • Recruiting
        • CLINUVEL investigational site
        • Contact:
  • Spain
      • Clinuvel Investigational Site, Spain
        • Recruiting
        • CLINUVEL investigational site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afamelanotide
Drug: Afamelanotide
Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minimal erythema dose (MED) in patients with XP-C.
Time Frame: From baseline to day 76.
MED is the lowest dose of UV light that causes reddening of the skin.
From baseline to day 76.
Change in MED in patients with XP-V.
Time Frame: From baseline to day 76.
MED is the lowest dose of UV light that causes reddening of the skin.
From baseline to day 76.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Analysis of UV photoproducts from skin samples.
From baseline to day 76.
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.
Analysis of DNA repair mechanisms from skin samples.
From baseline to day 76.
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.
Analysis of UV photoproducts from skin samples.
From baseline to day 76.
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.
Analysis of DNA repair mechanisms from skin samples.
From baseline to day 76.
Change in skin disease severity in patients with XP-C (A).
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in skin disease severity in patients with XP-V (A)
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in skin disease severity in patients with XP-C (B).
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in skin disease severity in patients with XP-V (B).
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in skin disease severity in patients with XP-C (C).
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in skin disease severity in patients with XP-V (C).
Time Frame: From baseline to day 76.
The higher the score, the more severe the disease.
From baseline to day 76.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-C.
Time Frame: From baseline to day 76.
Higher scores represent worse health-related quality of life.
From baseline to day 76.
Change in quality of life assessed by a disease specific tool (A) in patients with XP-V.
Time Frame: From baseline to day 76.
Higher scores represent worse health-related quality of life.
From baseline to day 76.
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.
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.
From baseline to day 76.
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.
Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.
From baseline to day 76.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinuvel Europe Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUV152

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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