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

NCT04402489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-12-30

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

Placebo

DRUG

MT-7117 Low Dose

MT-7117 Low Dose

DRUG

MT-7117 High Dose

MT-7117 High Dose

Sponsors & Collaborators

  • Tanabe Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Head of Medical Science · Tanabe Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-12-14
Completion
2022-07-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Japan
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402489 on ClinicalTrials.gov