Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

Last updated: March 24, 2026
Sponsor: Clinuvel Europe Limited
Overall Status: Completed

Phase

1/2

Condition

Anemia

Treatment

Afamelanotide 16mg implant

Clinical Study ID

NCT06388642
CUV052
  • Ages 12-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • EPP patients aged between 12 and 70 years

  • BMI between 15 and 30 kg/m2

  • >50 kg

Exclusion

Exclusion Criteria:

  • Any personal or direct family history of melanoma

  • Any significant history of allergy and/or sensitivity to any of the contents ofstudy drug product or lignocaine or other local anaesthetics if used

  • Any significant illness during the four weeks before the study screening period

  • Any evidence of hepatic or renal impairment

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Afamelanotide 16mg implant
Phase: 1/2
Study Start date:
March 07, 2024
Estimated Completion Date:
January 20, 2025

Connect with a study center

  • CLINUVEL Site

    Leuven,
    Belgium

    Site Not Available

  • CLINUVEL Site

    Leuven 2792482,
    Belgium

    Site Not Available

  • CLINUVEL Site

    Rotterdam,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • CLINUVEL Site

    Rotterdam 2747891,
    Netherlands

    Site Not Available

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