Conditions: Erythropoietic Protoporphyria (EPP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: MT-7117 low dose intervention 2: MT-7117 high dose intervention 3: Placebo
Intervention descriptions: intervention 1: MT-7117 low dose QD, oral, 16 weeks intervention 2: MT-7117 high dose QD, oral, 16 weeks intervention 3: Placebo QD, oral, 16 weeks

Protocol document:
Prot_000.pdf: 

























































































































































































































SAP_001.pdf: