NCT03520036

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Erythropoietic Protoporphyria (EPP)

Interventions

Type	Name	Description
DRUG	MT-7117 low dose	MT-7117 low dose QD, oral, 16 weeks
DRUG	MT-7117 high dose	MT-7117 high dose QD, oral, 16 weeks
DRUG	Placebo	Placebo QD, oral, 16 weeks

Timeline

• Start date: 2018-07-05
• Primary completion: 2019-09-28
• Completion: 2019-09-28
• First posted: 2018-05-09
• Last updated: 2025-12-31
• Results posted: 2023-01-20

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study