At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of EPP confirmed by elevated free protoporphyrin in peripheral erythrocytes
- ✓EPP of sufficient severity that patient has requested treatment
- ✓Age 18-70 years
- ✕Allergy to afamelanotide, the polymer implant, lignocaine, or other local anesthetics
- ✕Significant hepatic involvement in EPP
- ✕Personal history of melanoma or dysplastic nevus syndrome
- ✕Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP)
In Brief
A Phase 3 clinical trial evaluating Afamelanotide and Placebo for Erythropoietic Protoporphyria. Completed, enrolled 100 participants.
Detailed 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
Study Details
Timeline
Interventions
16mg subcutaneous implant
Placebo subcutaneous implant