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MT-7117 Low Dose for Erythropoietic Protoporphyria

Phase 3
Waitlist Available
Research Sponsored by Mitsubishi Tanabe Pharma America Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights

Study Summary

This trial is testing a drug to see if it can help people with a genetic disorder that makes them sensitive to sunlight.

Eligible Conditions
  • Erythropoietic Protoporphyria
  • Lymphoproliferative Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in average daily sunlight exposure time (minutes) to first prodromal symptom (burning, tingling, itching, or stinging) associated with sunlight exposure between 1 hour post sunrise and 1 hour pre-sunset at Week 26.
Secondary outcome measures
Patient Global Impression of Change (PGIC).
Total number of sunlight-induced pain events with pain rating of 1-10 on the Likert scale during the 26-week double-blind treatment period.
Other outcome measures
Change from baseline for total score in the domain of pain intensity in the PROMIS-57.
Change from baseline for total score in the domain of physical function in the PROMIS-57.
The percentage of subjects who are responders based on average daily sunlight exposure time to first prodromal symptom associated with sunlight exposure between 1 hour post sunrise and 1 hour pre-sunset defined by within-subject meaningful change.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MT-7117 Low DoseExperimental Treatment1 Intervention
Oral tablet of MT-7117 Low Dose once a day.
Group II: MT-7117 High DoseExperimental Treatment1 Intervention
Oral tablet of MT-7117 High Dose once a day.
Group III: Placebo ComparatorPlacebo Group1 Intervention
Oral tablet of placebo once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-7117 Low Dose
2020
Completed Phase 3
~190
MT-7117 High Dose
2020
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
2,968 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,298 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria
2020. "Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04402489.
~38 spots leftby Apr 2025
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