A Study of Navenibart in Participants with Hereditary Angioedema

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.

Conditions

Hereditary Angioedema (HAE)

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Study Overview

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Study Details

Study overview

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.

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

A Study of Navenibart in Participants with Hereditary Angioedema

Condition
Hereditary Angioedema (HAE)
Intervention / Treatment

-

Contacts and Locations

Walnut Creek

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Astria Therapeutics, Inc.,

Study Record Dates

2027-09