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Oral Dersimelagon for Erythropoietic Protoporphyria
Phase 3
Waitlist Available
Research Sponsored by Mitsubishi Tanabe Pharma Development America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
6. Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 further months
Awards & highlights
Study Summary
This trial looks at the side effects of a drug called dersimelagon.
Who is the study for?
This trial is for individuals with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP), weighing at least 30 kg, able to travel for visits, and not pregnant. They must have completed a previous MT-7117 study and agree to use two effective contraception methods if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing the long-term safety and tolerability of an oral medication called Dersimelagon (MT-7117) in patients with EPP or XLP who have previously participated in the initial MT-7117-G01 study.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of Dersimelagon as it relates to their liver function, skin conditions including melanoma risk, alcohol intake effects, psychiatric health stability, and overall organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not breastfeeding and have a negative pregnancy test.
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I am a woman, not breastfeeding, and my pregnancy test before starting the study drug was negative.
Select...
My body weight is at least 30 kg.
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My body weight is at least 30 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 further months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 further months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with Nevi appearance
Number of patients with Treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs] and adverse events of special interest [AESIs]).
Number of patients with abnormal Physical examination data
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dersimelagon 200mgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-7117
2021
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,331 Total Patients Enrolled
Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
3,001 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,185 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver tests show high levels of AST, ALT, ALP, or bilirubin.I am not breastfeeding and have a negative pregnancy test.I am a woman, not breastfeeding, and my pregnancy test before starting the study drug was negative.I can travel to the study location for all my appointments.I have had melanoma in the past.My body weight is at least 30 kg.My body weight is at least 30 kg.I have melanoma or lesions that might be melanoma.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am not taking any medications or supplements that could affect the study.I haven't had phototherapy or taken afamelanotide in the last 3 months.I haven't taken strong painkillers regularly in the last 4 weeks.I am using two effective birth control methods, including a barrier method.I haven't taken cimetidine or high-dose antioxidants in the last 4 weeks.I understand the study, its risks, and am willing to follow all rules and travel if needed.I do not have any skin conditions caused by light, except for EPP or XLP.I understand the study, its risks, and am willing to follow all rules and travel if needed.I have or might have skin cancer that hasn't been cleared with a biopsy.I haven't taken any experimental drugs recently, except dersimelagon.I can travel to the study location for all visits.Subjects who complete the entire course of the study must complete the MT-7117-G01.I have or had liver or bile duct disease that my doctor finds significant.Two or more of my close family members have had melanoma.I have kidney problems or am on dialysis.Subjects provided written informed consent to participate
Research Study Groups:
This trial has the following groups:- Group 1: Dersimelagon 200mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any participants needed for this research project?
"The clinical trial referenced is not actively recruiting patients as of 10/24/2022, according to data hosted on clinicaltrials.gov. This particular study was first posted on 8/10/2021. There are presently 4 other trials looking for volunteers."
Answered by AI
Has the United States Food and Drug Administration cleared MT-7117 for public consumption?
"There is existing clinical evidence to support the safety of MT-7117, as this drug has progressed to Phase 3 trials."
Answered by AI
At how many different hospitals or research centers is this clinical trial taking place?
"There are 16 total sites enrolling patients for this trial, including Marvel Clinical Research, LLC in Huntington Beach, California; The University of Texas Medical Branch (UTMB) in Galveston, Texas; and Remington-Davis Clinical Research in Columbus, Ohio."
Answered by AI
Who would be most likely to experience benefits from this clinical trial?
"This trial is open to 175 patients aged 12-75 who have epp. To be eligible, patients must also meet the following criteria: 1. Subjects provided written informed consent to participate. For adolescent subjects, both adolescent assent and parental consent will be provided., 2. Subjects who complete MT-7117-G01 (complete through Week 58 [Visit 12]), 3. Subjects have a body weight of ≥30 kg., 4. Subjects are willing and able to travel to the study sites for all scheduled visits., 5. In the Investigator's opinion, subject can understand the nature of the study and any risks involved in participation"
Answered by AI
Does the age limit for this type of research exclude elderly participants?
"This particular clinical trial has a lower age limit of 12 years old and an upper age limit of 75."
Answered by AI
Who else is applying?
What state do they live in?
California
New York
How old are they?
65+
What site did they apply to?
Marvel Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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