A Study of Navenibart in Participants With Hereditary Angioedema

Phase 3

Recruiting

• Conditions: Hereditary Angioedema (HAE)
• Interventions: Drug: navenibart; Drug: Placebo

• Registration Number: NCT06842823
• Lead Sponsor: Astria Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-24
• Status Verified: 2025-03
• Study Start: 2025-03-20
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Documented diagnosis of HAE (Type 1 or 2). The following must be met:

  1. Documented clinical history consistent with HAE
  2. Lab findings consistent with HAE Type 1 or 2

• Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion Criteria

• Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.

• Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period):

  1. Lanadelumab within 90 days prior to Run-In
  2. Berotralstat within 21 days prior to Run-In
  3. Plasma-derived C1INH for LTP within 14 days prior to Run-In
  4. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  5. All other prophylactic therapies, including investigational drugs, require consultation with the Medical Monitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.	Day 1 through Day 181

Secondary Outcome Measures

Name	Time	Method
Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.	Day 1 through Day 181
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction from the Run-In Period in investigator-confirmed HAE attack rate (for adult participants: compared to placebo during the 6-month Treatment Period).	Baseline through Day 181
Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period.	Day 1 through Day 181
Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.	Day 1 through Day 181
Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.	Baseline through Day 181
Time to first investigator-confirmed HAE attack after first and second dose.	Day 1 through Day 181
Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score.	Day 1 through Day 181

Trial Locations

Locations (8)

Site 8; 🇺🇸 Centennial, Colorado, United States

Site 7; 🇺🇸 Cincinnati, Ohio, United States

Site 2; 🇺🇸 Scottsdale, Arizona, United States

Site 3; 🇺🇸 Little Rock, Arkansas, United States

Site 4; 🇺🇸 Santa Monica, California, United States

Site 1; 🇺🇸 Walnut Creek, California, United States

Site 6; 🇺🇸 Wheaton, Maryland, United States

Site 5; 🇨🇦 Ottawa, Ontario, Canada