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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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