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COMPLETEDPHASE3

Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

NCT04739059•CSL Behring

View on ClinicalTrials.gov

Summary

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- Males and females aged ≥ 12 years
•\- Diagnosed with clinically confirmed C1-INH HAE
•\- Experienced ≥ 3 HAE attacks during the 3 months before Screening
•\- Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
•\- Experienced at least an average of 1 HAE attack per month during the Run-in Period

Exclusion Criteria

•\- Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
•\- Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
•\- Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
•\- Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
•\- Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
•\- Pregnant, breastfeeding, or not willing to cease breastfeeding

Locations (44)

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Research Solutions of Arizona

Litchfield Park, Arizona, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

Little Rock Allergy & Asthma Clinic

Little Rock, Arkansas, United States

Donald S. Levy M.D.

Orange, California, United States

Raffi Tachdjian MD, Inc.

Santa Monica, California, United States

Allergy & Asthma Clinical Research

Walnut Creek, California, United States

Institute for Asthma and Allergy PC

Chevy Chase, Maryland, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

PennState Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Key Dates

Start Date

April 29, 2021

Primary Completion Date

November 21, 2025

Completion Date

November 21, 2025

Last Updated

January 26, 2026

Enrollment

171

ACTUAL participants

Conditions

Hereditary Angioedema

Interventions

CSL312

BIOLOGICAL

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

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RECRUITINGPHASE3

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

NCT06960213

Hereditary AngioedemaHAE+2 more

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

A Study of Navenibart in Participants With Hereditary Angioedema

Institutional Registry of Rare Diseases

HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)