Viewing Study NCT06144840



Ignite Creation Date: 2024-05-06 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06144840
Status: RECRUITING
Last Update Posted: 2024-06-20
First Post: 2023-11-17

Brief Title: INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP
Sponsor: Mitsubishi Tanabe Pharma America Inc
Organization: Mitsubishi Tanabe Pharma America Inc

Study Overview

Official Title: A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy Safety and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: INSPIRE
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
jRCT2031230656 REGISTRY Japan Registry of Clinical Trials jRCT None