Multicentre Phase III Erythropoietic Protoporphyria Study
Status:
Completed
Trial end date:
2009-12-09
Target enrollment:
Participant gender:
Summary
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to
evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in
patients with Erythropoietic Protoporphyria (EPP).
The study was conducted with two parallel study arms with crossover between treatments every
60 days.
Eligible patients were randomised to a treatment group, and received implants of active
treatment (afamelanotide 16mg) or placebo, in an alternating crossover fashion according to
the following dosing regime:
- Group A was administered active implants on Days 0, 120, 240 and placebo implants on
Days 60, 180, 300
- Group B was administered placebo implants on Days 0, 120, 240 and active implants on
Days 60, 180, 300