Phase III Trial of 16 mg Afamelanotide in EPP
Research type
Research Study
Full title
A Phase III, multicentre, double-blind, randomised, placebo-controlled study to confirm the safety and efficacy of subcutaneous bioresorbable afamelanotide Implants in patients with erythropoietic protoporphyria (EPP)
Sponsor organisation
Clinuvel Pharmaceuticals Limited, Australia
Eudract number
2009-011018-51
ISRCTN Number
1
Research summary
Afamelanotide is a man-made drug that's being studied for use as a preventative medication for sufferers of polymorphic light eruption - a type of sun allergy. The main purpose of the study is to determine whether afamelanotide can reduce the severity of phototoxic reactions in patients with EPP.The study drug is not yet approved for marketing in any country and its use in this study is therefore experimental.The study will involve the use of an implant which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. This implant will contain the drug afamelanotide.Over 300 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a slow release depot injection (implant). This means that the afamelanotide will be released slowly into the body over approximately 10 to 15 days. Once inserted, theimplant will remain in the body after afamelanotide has been released and will slowly dissolve.This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers.Up to 70 people will participate in this study. Patients will be recruited from 6 study centres in United Kingdom, Germany, Finland, Norway and the Netherlands. Approximately 12 patients will be recruited at this site.
REC name
Wales REC 2
REC reference
09/WSE02/32
Date of REC Opinion
15 Jun 2009
REC opinion
Further Information Favourable Opinion