A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Astria Therapeutics, Inc.
Study ID
NCT07204938
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.

Study Details

This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

Key Dates

Start date
Oct 1, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
145 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Adult Dosing Regimen 1
    Participants will receive 600 mg of navenibart every 3 months.
  • Experimental: Adult Dosing Regimen 2
    Participants will receive 300 mg of navenibart every 3 months.
  • Experimental: Adult Dosing Regimen 3
    Participants will receive 600 mg of navenibart every 6 months.
  • Experimental: Adolescent Dosing Regimen 1
    Participants will receive 300 mg of navenibart every 3 months.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 through Month 48 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Site 2ScottsdaleArizona85251-
Site 3Little RockArkansas72205-
Site 7San DiegoCalifornia92122-
Site 4Santa MonicaCalifornia90404-
Site 1Walnut CreekCalifornia94598-
Site 5CentennialColorado80112-
Site 19Colorado SpringsColorado80907-
Site 21WheatonMaryland20902-
Site 6CincinnatiOhio45236-
Site 9HersheyPennsylvania17033-

Find similar trials in Scottsdale, AZ

By research site
Site 2· Scottsdale, AZSite 3· Little Rock, ARSite 7· San Diego, CASite 4· Santa Monica, CASite 1· Walnut Creek, CASite 5· Centennial, CO

Related Studies