A Study of Navenibart in Participants With Hereditary Angioedema

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Astria Therapeutics, Inc.
Study ID
NCT06842823
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Hereditary Angioedema (HAE)

Eligibility Criteria

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

Interventions

  • navenibart — DRUG
    Navenibart will be administered as a subcutaneous injection.
  • Placebo — DRUG
    Placebo will be administered as a subcutaneous injection.

Study Details

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.

Key Dates

Start date
Mar 20, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adult Navenibart Dosing Regimen 1
    Participants will receive 600 mg of navenibart every 3 months.
  • Experimental: Adult Navenibart Dosing Regimen 2
    Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
  • Experimental: Adult Navenibart Dosing Regimen 3
    Participants will receive 600 mg of navenibart every 6 months.
  • Placebo Comparator: Placebo (adult)
    Participants will receive placebo every 3 months.
  • Experimental: Adolescent Navenibart Dosing Regimen 1
    Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Primary Outcome Measure

Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period. [ Time Frame: Day 1 through Day 181 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Site 9BirminghamAlabama35209-
Site 2ScottsdaleArizona85251-
Site 3Little RockArkansas72205-
Site 14San DiegoCalifornia92123,-
Site 26San DiegoCalifornia92122-
Site 4Santa MonicaCalifornia90404-
Site 1Walnut CreekCalifornia94598-
Site 8CentennialColorado80112-
Site 11Colorado SpringsColorado80907-
Site 25TampaFlorida33613-
Site 69WestonFlorida33331-
Site 6WheatonMaryland20902-
Site 67BostonMassachusetts02114-
Site 13DetroitMichigan48202-
Site 10St LouisMissouri63141-
Site 7CincinnatiOhio45236-
Site 12ToledoOhio43617-
Site 15HummelstownPennsylvania17036-
Site 86DallasTexas75231-

Find similar trials in Birmingham, AL

By research site
Site 9· Birmingham, ALSite 2· Scottsdale, AZSite 3· Little Rock, ARSite 14· San Diego, CASite 26· San Diego, CASite 4· Santa Monica, CA

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