Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373731
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-16
Brief Title:
ReNEWPhase 3 Study of Efficacy Safety Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration Dry AMD
Sponsor:
Stealth BioTherapeutics Inc
Organization:
Stealth BioTherapeutics Inc
Study Overview
Official Title:
ReNEW A Phase 3 Double-Masked Placebo-Controlled Clinical Trial to Evaluate the Efficacy Safety and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects Who Have Dry Age-Related Macular Degeneration Dry AMD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ReNEW
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration AMD The main questions it aims to answer are what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug and what is the safety and tolerability of elamipretide daily subcutaneous injections Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared
Detailed Description:
The ReNEW SPIAM-301 trial is a phase 3 randomized double-masked parallel-group placebo-controlled clinical trial to evaluate the efficacy safety and pharmacokinetics of a once daily subcutaneous SC injection of elamipretide in subjects who have dry AMD Subjects will be randomized 21 to once daily SC doses of 40 mg elamipretide or placebo for 96 weeks of treatment by a central randomization and stratified by SD-OCT device type Heidelberg SPECTRALIS ZEISS CIRRUS and baseline macular area of photoreceptor loss defined as an ellipsoid zone-retinal pigment epithelium EZ-RPE thickness of 0μm assessed by SD-OCT and ellipsoid zone EZ mapping High Strata 51mm2 Low Strata 51mm2
Primary Objective
Evaluate the efficacy of once daily subcutaneous SC injections of elamipretide in subjects who have dry age-related macular degeneration AMD Secondary Objectives
Evaluate the safety and tolerability of once daily SC injections of elamipretide
Evaluate the Pharmacokinetic PK profile of elamipretide and its metabolites
Primary Objective
Evaluate the efficacy of once daily subcutaneous SC injections of elamipretide in subjects who have dry age-related macular degeneration AMD Secondary Objectives
Evaluate the safety and tolerability of once daily SC injections of elamipretide
Evaluate the Pharmacokinetic PK profile of elamipretide and its metabolites
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