RECRUITING

A Study of Navenibart in Participants with Hereditary Angioedema

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Conditions

Hereditary Angioedema (HAE)HAEAngioedema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema (HAE)

Quick Facts

Study Start:2025-03
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06842823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of HAE (Type 1 or 2). The following must be met:
  2. 1. Documented clinical history consistent with HAE
  3. 2. Lab findings consistent with HAE Type 1 or 2
  4. * 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.
  1. * 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.
  2. * 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):
  3. 1. Lanadelumab within 90 days prior to Run-In
  4. 2. Berotralstat within 21 days prior to Run-In
  5. 3. Plasma-derived C1INH for LTP within 14 days prior to Run-In
  6. 4. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  7. 5. All other prophylactic therapies, including investigational drugs, require consultation with the Medical Monitor

Contacts and Locations

Study Contact

Claire VanEenwyk, MD
CONTACT
1-617-349-1971
alphaorbit_general@astriatx.com

Study Locations (Sites)

Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
United States

Collaborators and Investigators

Sponsor: Astria Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-03
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • HAE
  • Angioedema

Additional Relevant MeSH Terms

  • Hereditary Angioedema (HAE)