← Back to Search

Other

Dersimelagon for Erythropoietic Protoporphyria (INSPIRE Trial)

Phase 3

Recruiting

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

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.

Subjects aged 12 years to 75 years, inclusive, at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

INSPIRE Trial Summary

This trial tests a drug to reduce symptoms of EPP or XLP when exposed to sunlight.

Who is the study for?

This trial is for adults and adolescents aged 12-75 with Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP). Participants must not be pregnant, should agree to use two forms of contraception, and be willing to expose themselves to sunlight. They cannot have certain liver conditions, drug abuse history, other skin diseases besides EPP/XLP, or be on conflicting medications.Check my eligibility

What is being tested?

The trial tests Dersimelagon's effectiveness against a placebo in delaying the onset and reducing the severity of symptoms like burning or itching caused by sun exposure in people with EPP/XLP. It involves direct sunlight exposure as part of the study.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will monitor any discomforts that could arise from increased sun exposure such as skin irritation or photosensitivity reactions due to their condition.

INSPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not breastfeeding and have a negative pregnancy test.

Select...

I am between 12 and 75 years old.

Select...

I have been diagnosed with EPP or XLP.

INSPIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 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 16

Secondary outcome measures

Patient Global Impression of Change (PGIC) at Week 16.

Total number of sunlight-induced non-prodrome, phototoxic reactions during the 16-week double-blind treatment period.

Total number of sunlight-induced pain events defined as prodromal symptoms (burning, tingling, itching, or stinging) with pain rating of 1-10 on the Likert scale during the 16-week double-blind treatment period.

INSPIRE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MT-7117Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mitsubishi Tanabe Pharma America Inc.Lead Sponsor

26 Previous Clinical Trials

3,002 Total Patients Enrolled

Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.

17 Previous Clinical Trials

2,186 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What can be ascertained about the safety of MT-7117 from current research?

"Our company has assigned the safety of MT-7117 a score of 3 due to its Phase 3 trial status which indicates that there is evidence for efficacy and multiple indicators demonstrating its security."

Answered by AI

Is there an opportunity to join this research endeavor?

"Candidates who are suffering from erythropoietic protoporphyria and aged between 12-75 can apply to this trial. A total of 150 spots are available for enrollment."

Answered by AI

Is this research survey presently looking for new participants?

"The information provided on clinicaltrials.gov confirms that this study is not currently accepting new participants. Initially posted in December of 2023, it was last updated a month ago; however, there are 17 other trials actively recruiting patients presently."

Answered by AI

How far has the geographic reach of this experiment extended?

"This medical trial is based in the University of California at San Francisco (San Francisco, CA); Florida, University Of Miami School Of Medicine, Center For Liver Diseases (Miami fl) and MGH in Boston ma. Additionally there are 26 other sites across the US where patients can participate."

Answered by AI

Does this research endeavor provide an opportunity for elderly participants?

"The age parameters for this clinical trial are from 12 to 75 years old. Separately, there will be trials dedicated solely to patients below 18 and above 65 respectively; these include 12 studies and 15 studies respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP

2023. "INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144840.

All > Kansas City > Cleveland