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RecruitingNCT05159752Updated Jun 18, 2023

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

A Phase 2 interventional study of Afamelanotide in Xeroderma Pigmentosum, sponsored by Clinuvel Europe Limited. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Clinuvel Europe Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Xeroderma Pigmentosum

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Afamelanotide

    Drug: Afamelanotide

Interventions

  • DrugAfamelanotide

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

05

What researchers measure

Primary outcomes

  1. Change in minimal erythema dose (MED).

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

    Time frame: From Baseline to Day 76.

Secondary outcomes

  1. Change in UV-induced DNA damage and repair capacity.

    Analysis of UV photoproducts and DNA repair mechanisms.

    Time frame: From Baseline to Day 76.

  2. Change in skin disease severity (A).

    The higher the score, the more severe the disease.

    Time frame: From Baseline to Day 238.

  3. Change in skin disease severity (B).

    The higher the score, the more severe the disease.

    Time frame: From Baseline to Day 238.

  4. Change in skin disease severity (C).

    The higher the score, the more severe the disease.

    Time frame: From Baseline to Day 238.

  5. Change in dermal melanin density.

    Non-invasive quantitative skin reflectance measurement.

    Time frame: From Baseline to Day 238.

  6. Change in quality of life assessed by a disease specific tool (A)

    Higher scores represent worse health-related quality of life.

    Time frame: From Baseline to Day 238.

  7. Change in quality of life assessed by a validated global quality of life tool (B)

    Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life.

    Time frame: From Baseline to Day 238.

06

Study locations

1 of 1 sites recruiting
  • CLINUVEL investigative site
    Regensburg, Germany
    Recruiting
07

Registry details

Key details

Study ID
NCT05159752
Lead sponsor
Clinuvel Europe Limited
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Oct 19, 2021
Primary completion
Mar 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Jun 18, 2023

Study contacts

Head of Clinical Operations
Contact
mail@clinuvel.com
+441372860765

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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