Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria

Erythropoietic Protoporphyria (EPP) Clinical Trial

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP.

Clinical Trial Description

This is a Phase 2, randomized, double-blind, placebo controlled study to assess the efficacy, tolerability, and safety of MT-7117 in subjects with EPP. The study consists of a 2 week screening period, a 16 week double-blind treatment period, and a 6 week follow-up period at Week 22. The total participation period is approximately 24 weeks. ;

Related Conditions & MeSH terms

• Erythropoietic Protoporphyria (EPP)

• NCT number: NCT03520036
• Study type: Interventional
• Source: Mitsubishi Tanabe Pharma America Inc.
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2018
• Completion date: September 28, 2019