Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343779
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-03-18
Brief Title:
Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Sponsor:
Pharvaris Netherlands BV
Organization:
Pharvaris Netherlands BV
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema
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:
RAPIDe-3
Brief Summary:
This is a Phase 3 multicenter randomized double-blind placebo-controlled 2-period 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks including non-severe laryngeal attacks in participants 12 to 75 years of age with HAE type 1 or type 2 HAE-12 a proportion of whom are using long-term prophylactic medication for HAE
Detailed Description:
The study consists of a Screening Phase during which eligibility is confirmed a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks ie 2 Treatment Periods within the Treatment Phase and an End-of-Study Follow-up Phase after the second attack treated with study drug In addition for adolescent participants age 12 to 18 years PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state
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