NCT06388642

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2024

Geographic Reach
2 countries

2 active sites

Status
completed

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 7, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

April 4, 2024

Last Update Submit

March 24, 2026

Conditions

Erythropoietic Protoporphyria

Outcome Measures

Primary Outcomes (2)

  • Cmax (maximum Plasma Concentration)

    Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.

    Baseline to Day 7

  • AUC(0-t) (area under the curve from administration to last observed concentration at time t)

    Blood samples will be collected for analysis of afamelanotide plasma concentrations.

    Baseline to Day 7

Secondary Outcomes (1)

  • AUC(0-∞) (area under the curve extrapolated to infinite time)

    Baseline to Day 7

Study Arms (1)

Afamelanotide 16 mg implant

EXPERIMENTAL
Drug: Afamelanotide 16mg implant

Interventions

Afamelanotide 16mg implantDRUG

afamelanotide 16mg implant will be administered to each patient during the study.

Also known as: SCENESSE®
Afamelanotide 16 mg implant

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • EPP patients aged between 12 and 70 years
  • BMI between 15 and 30 kg/m2
  • \>50 kg

You may not qualify if:

  • Any personal or direct family history of melanoma
  • Any significant history of allergy and/or sensitivity to any of the contents of study 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CLINUVEL Site

Leuven, Belgium

Location

CLINUVEL Site

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Protoporphyria, Erythropoietic

Interventions

afamelanotideDrug Implants

Condition Hierarchy (Ancestors)

Porphyrias, HepaticLiver DiseasesDigestive System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPorphyriasMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 29, 2024

Study Start

March 7, 2024

Primary Completion

October 28, 2024

Study Completion

January 20, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

NL(1)BE(1)