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

ClinicalTrials.gov ID: NCT04402489

Public ClinicalTrials.gov record NCT04402489. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 18, 2026, 5:37 AM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04402489
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Tanabe Pharma America, Inc.; Industry
Enrollment: 184 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 12 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 1, 2020 (Actual)
Primary completion: Dec 14, 2021 (Actual)
Completion: Jul 26, 2022 (Actual)
Last update posted: Dec 30, 2025

2020 – 2022

United States locations

U.S. sites: 10
U.S. states: 10
U.S. cities: 10

Facility	City	State	ZIP	Site status
Marvel Clinical Research, LLC	Huntington Beach	California	92647	—
University Of Miami School Of Medicine, Center For Liver Diseases	Miami	Florida	33136	—
MetroBoston Clinical Partners, LLC	Brighton	Massachusetts	02135	—
Kansas City Research Institute	Kansas City	Missouri	64131	—
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)	New York	New York	10029	—
Wake Forest University Baptist Health	Winston-Salem	North Carolina	27109	—
Remington-Davis Clinical Research	Columbus	Ohio	43215	—
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	—
The University of Texas Medical Branch (UTMB)	Galveston	Texas	77555	—
University of Washington-Seattle Cancer Care Alliance	Seattle	Washington	19023	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04402489, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 30, 2025 · Synced Oct 18, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04402489 live on ClinicalTrials.gov.

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