CompletedPhase 1/2

Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

Belgium, Netherlands28 participantsStarted 2024-03-07

Plain-language 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.

Who can participate

Age range

12 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * EPP patients aged between 12 and 70 years * BMI between 15 and 30 kg/m2 * \>50 kg Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax (maximum Plasma Concentration)

Timeframe: Baseline to Day 7

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

Timeframe: Baseline to Day 7

Trial details

NCT IDNCT06388642

SponsorClinuvel Europe Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-28

Results submitted2026-03-24

View on ClinicalTrials.gov More Erythropoietic Protoporphyria trials

Who can participate

Age range

12 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.