Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pharvaris Netherlands B.V.
Study ID
NCT06679881
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hereditary Angioedema (HAE)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deucrictibant — DRUG
    Deucrictibant extended-release tablet for once daily oral use

Study Details

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

Key Dates

Start date
Feb 1, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Deucrictibant
    Deucrictibant

Primary Outcome Measure

Treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation [ Time Frame: 130 weeks ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Study SiteBirminghamAlabama35209-
Study SiteScottsdaleArizona85251-
Study SiteLittle RockArkansas72205-
Study SiteSan DiegoCalifornia92122-
Study SiteSanta MonicaCalifornia90404-
Study SiteWalnut CreekCalifornia94598-
Study SiteWheatonMaryland20902-
Study SiteSt LouisMissouri63141-
Study SiteLas VegasNevada89128-0450-
Study SiteHersheyPennsylvania17033-
Study SiteDallasTexas75231-
Study SiteMilwaukeeWisconsin53226-3067-

Find similar trials in Birmingham, AL

By research site
Study Site· Birmingham, ALStudy Site· Scottsdale, AZStudy Site· Little Rock, ARStudy Site· San Diego, CAStudy Site· Santa Monica, CAStudy Site· Walnut Creek, CA

Related Studies