CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04402489
NCT04402489Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria

Tanabe Pharma America, Inc.·interventional·Posted May 26, 2020·Updated Dec 30, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo, MT-7117 Low Dose, and 1 other intervention for EPP and XLP. Completed, enrolled 184 participants across 31 sites in 10 countries.

Detailed Summary

The primary objective of this study is to investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP aged 12-75.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEPP, XLP
CountriesAustralia, Canada, Germany, Italy, Japan, Norway, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 26, 2020
Enrollment StartJun 1, 2020
Primary CompletionDec 14, 2021
Study CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.1 years ago

Interventions

Placebodrug

Placebo

MT-7117 Low Dosedrug

MT-7117 Low Dose

MT-7117 High Dosedrug

MT-7117 High Dose