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A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Hereditary Angioedema (HAE)

Interventions

DRUG

navenibart

Navenibart will be administered as a subcutaneous injection.

DRUG

Placebo

Placebo will be administered as a subcutaneous injection.

Sponsors & Collaborators

  • Astria Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-03-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • North Macedonia
  • Poland
  • Portugal
  • Puerto Rico
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842823 on ClinicalTrials.gov