Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634420
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
HAELO a Phase 3 Study to Evaluate NTLA-2002 in Participants with Hereditary Angioedema HAE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HAELO a Phase 3 Multinational Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants with Hereditary Angioedema HAE
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in adult participants with HAE
Detailed Description:
This is a multinational multicenter double-blind placebo-controlled study in which approximately 60 participants will be randomized in a 21 ratio to receive a single IV infusion of NTLA-2002 or placebo After the Primary Observation Period Week 1 through Week 28 participants will have the option to receive a blinded single IV infusion of the opposite treatment Following the Primary Observation Period participants will enter the Long-Term Observation Period 76 weeks for a total of 104 weeks Including the Screening and Run-In Period prior to the first blinded dosing the total study duration is approximately 28 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None