NCT05370235

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2022

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

April 21, 2022

Last Update Submit

September 20, 2023

Conditions

Xeroderma Pigmentosum

Outcome Measures

Primary Outcomes (2)

  • Change in minimal erythema dose (MED) in patients with XP-C.

    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.

    MED is the lowest dose of UV light that causes reddening of the skin.

    From baseline to day 76.

Secondary Outcomes (14)

  • Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C.

    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.

    From baseline to day 76.

  • Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V.

    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.

    From baseline to day 76.

  • Change in skin disease severity in patients with XP-C (A).

    From baseline to day 76.

  • +9 more secondary outcomes

Study Arms (1)

Afamelanotide

EXPERIMENTAL
Drug: Afamelanotide

Interventions

AfamelanotideDRUG

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

Afamelanotide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
  • Aged 18-75 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CLINUVEL Investigational site

Clinuvel Investigational Site, Belgium

RECRUITING

CLINUVEL Investigational site

Clinuvel Investigational Site, Spain

RECRUITING

MeSH Terms

Conditions

Xeroderma Pigmentosum

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornPhotosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesPigmentation DisordersDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Head of Clinical Operations

CONTACT

+441372860765mail@clinuvel.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 11, 2022

Study Start

March 28, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

BE(1)ES(1)