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NCT05005975 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
A Phase 3 study of EPP and XLP, sponsored by Tanabe Pharma America.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT05005975: Recruiting Phase 3 study of EPP and XLP, sponsored by Tanabe Pharma America.
NCT05005975 is a Phase 3 study of EPP and XLP that is actively recruiting participants, run by Tanabe Pharma America. The registered enrollment target is 301 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005975, a Phase 3 study of EPP and XLP, is actively recruiting participants, sponsored by Tanabe Pharma America.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the long-term safety and tolerability of oral dersimelagon.
Primary Outcome
Vital signs (blood pressure, respiratory rate, pulse rate, and body temperature), Clinical laboratory examinations (hematology, coagulation, biochemistry, urinalysis, and others), 12-lead electrocardiogram (ECG) parameters (Mean Heart Rate, PR Interval, QRS Duration, QT interval, QTcB and QTcF) will be assessed.
Interventions
- DRUG MT-7117
Study Locations (20)
California
- Marvel Clinical Research, LLC - Huntington Beach
- University of California at San Francisco - CSF Porphyria Center - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
- MetroBoston Clinical Partners, LLC - Brighton
Ohio
- Cleveland Clinic - Taussig Cancer Institute - Cleveland
- Remington-Davis Clinical Research - Columbus
Pennsylvania
- Thomas Jefferson University - Philadelphia
- Einstein Medical Center, Philadelphia - Philadelphia
Florida
- University Of Miami School Of Medicine, Center For Liver Diseases - Miami
Michigan
- Henry Ford Health System - Detroit
Missouri
- Kansas City Research Institute - Kansas City
New York
- Icahn School of Medicine at Mount Sinai (ISSMS)-The Mount Sinai Hospital (MSH) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT05005975 shows while recruiting
NCT05005975 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with EPP appearing as the primary indexed condition, and to 1 intervention - of which MT-7117 is the first listed.
NCT05005975 names 20 study sites across 16 states, led by California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT05005975 about?
NCT05005975 is a clinical study titled "Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)". To evaluate the long-term safety and tolerability of oral dersimelagon.
What is the current status of trial NCT05005975?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2021-08-10. Estimated completion is 2027-12.
What conditions does trial NCT05005975 study?
This clinical trial studies the following conditions: EPP, XLP.
What interventions are being tested in trial NCT05005975?
The interventions under investigation include: MT-7117 (DRUG).
Who is sponsoring clinical trial NCT05005975?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05005975 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05005975's enrollment target sits among peer trials
301 1122nd of 2000 higher than 879 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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