Create a True Partnership with your Physician To Better Manage Your HAE

We personally invite you to use an exciting (and free!) resource to prepare for your next HAE appointment: The HAEA Shared Decision Making Tool (HAEA SDM).

By answering a series of questions, HAEA SDM summarizes your:

• Recent experience with HAE,
• Current treatments, and
• Preferences and what matters most to you when considering an HAE treatment.

This information is compiled into a downloadable one-page summary overview that serves as a basis for a more collaborative treatment-oriented discussion with your HAE physician.

HAEA SDM will help you and your doctor create a treatment plan that truly fits you.

Access HAEA SDM Tool Here: https://www.haea.org/pages/p/sdm_tool
If you have any questions, need assistance using the tool, or would like to share feedback, please contact the HAEA Health Team at health@haea.org.

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Connection, Conversation, and Community in Hershey, Pennsylvania!

Members of the HAEA community and HAEA staff came together last month in Hershey, PA, for a wonderful HAEA Community Connections event at Hershey Gardens!

The event provided a wonderful opportunity to connect with others who understand life with HAE, exchange experiences, and strengthen the sense of community that brings us together.

Don’t miss an opportunity to connect with the HAEA community! Find an upcoming HAEA Event in your area by visiting the HAEA Events Page!

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#BeyondHAE Voices of the Next Generation: Nick and Dylan

In this episode of the BeyondHAE Podcast, meet Nick and Dylan, two new members of the HAEA Youth Leadership Council, as they share their personal journeys to diagnosis, experiences managing HAE symptoms, and what it means to become part of a community of people who truly understand life with HAE. Together, they discuss balancing HAE with active lifestyles, including their involvement in sports, and the importance of building confidence, resilience, and self-advocacy skills.

Nick and Dylan inspire other young people living with HAE to take an active role in managing their health, pursue their passions, and never let HAE define their potential. Their message is important: with the right support, knowledge, and determination, HAE does not have to stand in the way of living life to the fullest.

Listen to the episode by clicking HERE!

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Read this Month’s HAEA Community Blog
A Mother’s Struggle with HAE Empowered Her Son’s Positive Outlook and Expectations for a Better Future
Living with HAE, Nikia Davis has seen tremendous progress across generations. In this Q&A, she shares how her experiences shaped parenting a son with HAE and the importance of advocacy, community, and advancing care.

Read more about it HERE!
Interested in sharing your story? Please contact Carlie Hines at carlie@haea.org!

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Read this month’s HAEA Community Blog articles!

• Topic: Bradykinin Signaling: A Clear Path Forward
• Guest Speakers: Brian Pfister, Executive Director, North America Head of Medical Affairs at Pharvaris, and Mary Uhlenhopp, Executive Director of Global Patient Advocacy at Pharvaris
• Sponsored by: Pharvaris

You can access the fully on-demand webinar by clicking HERE!

• Topic: Living Beyond Swells: Managing HAE with Confidence
• Guest Speakers: Shahnaz Fatteh, MD, and Nicolle (Individual with HAE)
• Sponsored by: Pharming

You can access the fully on-demand webinar by clicking HERE!
Interested in sharing your story? Please contact Carlie Hines at carlie@haea.org!

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Health Awareness and HAEA CARE Groups (Community, Acceptance, Respect, Empathy)

Celebrating Independence: Living Fully with HAE

For many people living with HAE, independence once meant carefully planning daily routines, travel, work, school, and family events around the uncertain timing of an attack.

Today, the HAE community has much to celebrate. Modern preventive and on-demand therapies have helped reduce attack frequency and severity, allowing many patients to pursue careers, education, travel, and personal goals with greater confidence. Increased HAE awareness, grassroots advocacy, and ongoing research bringing new therapies continue to improve the quality of life across the HAEA community.

As we celebrate independence, we also recognize the strength and resilience of those living with HAE, as well as the caregivers, healthcare providers, researchers, and advocates who have helped make this progress possible. Together, we look forward to a future where every person with HAE has access to the care and treatments they need to thrive.

We would love to have you join one of our CARE groups. This month we will talk about how living with HAE can make you stronger than you think you are.

Upcoming HAEA CARE Groups

• 1st Wednesday Evening of the month at 7:30 PM EST / 4:30 PM PST
• 2nd Thursday Morning of the month at 11:00 AM EST / 8:00 AM PST
• 3rd Tuesday Evening of the month at 10:00 PM EST / 7:00 PM PST

The HAEA Health team is here for you. Contact us at health@haea.org or 866-798-5598.

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What is a Clinical Trial?
Clinical trials are research studies conducted to evaluate whether a medicine to treat HAE is safe and effective in humans. Clinical trials are a critical part of drug development and are required before a treatment can be approved by the Food and Drug Administration (FDA) and become available by prescription.

What are the benefits of participating in a Clinical Trial?
Clinical trials can offer an open-label extension, which provides free access to HAE medicines being studied until they are approved and commercially available. Participation in a clinical trial also provides regular touchpoints with an HAE physician throughout the trial period and allows you to take a more active role in your health care.

The following is a list of clinical trials currently underway. If you are interested in receiving more information about clinical trials or in participating in any of the trials listed below, please fill out the Clinical Trial Interest Form.

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ALPHA-ORBIT Trial

The US HAEA is currently assisting Astria Therapeutics in recruiting participants for the ALPHA-ORBIT trial, a Phase 3 worldwide clinical research study to investigate the safety and effectiveness of an investigational subcutaneous injection (Navenibart) given every 3 or 6 months to prevent Hereditary Angioedema (HAE) attacks.

This is a placebo-controlled study, with a higher chance of receiving the study drug than the placebo. The use of an approved on-demand medication to treat acute attacks is permitted.

You may qualify for the ALPHA-ORBIT trial if you are diagnosed with HAE Type I or II and are 12 years of age or older. After completing the ALPHA-ORBIT trial, participants may be eligible to join the long-term extension study and continue receiving Navenibart to prevent HAE attacks at no cost.

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BW-20805-2001 Trial

The US HAEA is currently assisting Argo Pharmaceuticals in recruiting people with HAE for the BW-20805-2001 study.

The BW-20805-2001 trial is a Phase 2 study evaluating a new treatment, siRNA, which interferes with the production of the plasma kallikrein (PKK) gene and is intended for long acting prevention of HAE attacks. BW-20805-2001 is delivered subcutaneously once every 3 or 6 months.

This is not a placebo controlled trial. Participants will be assigned one of three dosing schedules for the study drug. Following completion of the study, participants will be offered the opportunity to continue treatment with BW-20805-2001 through an open label extension (OLE) study.

You may qualify for the BW-20805-2001 study if you are between 18 and 70 years old and diagnosed with HAE Type I or II.

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CHAPTER-4 Open Label Extension Trial

The US HAEA is currently assisting Pharvaris in recruiting for CHAPTER-4, the open-label extension (OLE) study for the CHAPTER-3 trial.

All participants who joined the CHAPTER-4 trial will receive the once-daily drug deucrictibant at no cost until it is approved for commercial use by the Food and Drug Administration (FDA). The benefits of enrolling in an OLE study include having continued access to treatment, receiving an investigational drug that has shown promise in a previous trial under close medical supervision, and contributing valuable data to advance HAE treatment options.

Participants must be diagnosed with HAE, be 12 years of age or older, and have access to standard-of-care on-demand treatment to manage any HAE attacks that may occur. The CHAPTER-4 study will last 2.5 years and require dedicated on-site visits, though some may be completed virtually.

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CREAATE Trial

The US HAEA is currently assisting Pharvaris in recruiting people for the CREAATE trial, a Phase 3 worldwide clinical research study to investigate the safety and effectiveness of an investigational once-daily oral drug (deucrictibant) to prevent Acquired Angioedema (AAE) attacks.

This is a placebo-controlled study, with equal chances of receiving the study drug or a placebo. The use of an approved on-demand medication to treat acute attacks is permitted.

You may qualify for the CREAATE trial if you are diagnosed with AAE, are 18 years of age or older, and have access, ability, and experience using standard-of-care on‑demand HAE treatment to manage AAE attacks. After completing the CREAATE Study, participants may be eligible to join the open-label extension (OLE) study and continue receiving deucrictibant to prevent AAE attacks at no cost.

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CSL312_4002 Trial

The US HAEA is currently assisting CSL Behring with recruitment for the CSL312_4002 study, a Phase 4 open-label clinical trial evaluating the subcutaneous injection garadacimab (formerly known as CSL312, brand name, Andembry) for HAE attack prevention.

This study is open to people with HAE who are:

• 12 years of age and older,
• Currently using a long-term prophylactic therapy, and
• Interested in switching to garadacimab.

All participants will receive garadacimab at no cost, starting with an initial loading dose followed by monthly subcutaneous injections for two months. No washout period is required as the dosing schedule is determined by the previous preventive therapy’s schedule.

The study will evaluate safety after switching therapies. Use of on-demand medication for acute attacks is permitted.

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GREAT Study

The US HAEA is currently assisting CSL Behring with recruitment for the Garadacimab Real-World Treatment Outcomes of Effectiveness, Safety, and Quality-of-Life in People with HAE (GREAT Study).

The GREAT study is an observational study for individuals 12 years of age or older who have started garadacimab and are willing to provide data over a 48-month period by recording attacks in an electronic HAE eDiary.

Enrollment in this study is contingent upon the participant having a prescription for the monthly use of garadacimab. No medication is provided by the sponsor.

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OASISjunior Trial

The US HAEA is partnering with Ionis Pharmaceuticals to enroll children and adolescents in the OASISjunior study, a Phase 3 clinical trial evaluating donidalorsen as an investigational therapy for HAE in children.

Donidalorsen works by reducing prekallikrein (PKK), a protein in the body that can trigger HAE attacks.

This study is open to children and adolescents with HAE who are ages 2 to less than 12 years old, diagnosed with HAE Type I or II, and are either new to treatment or already on long-term prophylaxis for HAE.

All participants will receive donidalorsen at no cost for the 18-month duration of the study, and will be required to visit the study clinic for scheduled assessments.

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STOP-HAE Trial

The US HAEA is currently assisting ADARx Pharmaceuticals in recruiting people with HAE for the STOP-HAE study.

This Phase 3 study is evaluating a new treatment ADX-324. This potential therapy employs Small Interfering RNA (siRNA) technology, which is a molecular tool that, in effect, tells cells to “stop making this specific protein”. ADX-324, which is designed to be a long lasting subcutaneous preventative therapy, targets plasma kallikrein, a key protein in the biochemical process that ultimately causes an HAE attack.

This is a placebo-controlled trial in which two out of three participants will receive the study drug. Participants will receive two injections of ADX-324 or a placebo over the course of eight months. Following completion of the study, participants will be offered the opportunity to continue taking ADX-324 through an open label extension study.

Eligible participants must be 18 years or older, diagnosed with HAE Type I or Type II, and willing to stop taking their current preventive medication.

If you have HAE Type I, Type II, HAE with Normal C1-Inhibitor, or AAE and are interested in learning about new clinical studies to prevent attacks, please fill out the Clinical Trial Interest Form to see if there is an active clinical trial site in your area.

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Update Your HAEA Membership!

Now is the perfect time to make sure we have your most up-to-date information so you never miss important updates on:

• HAE therapies & Clinical Trials,
• Community Events,
• Educational Resources,
• Legislative & Advocacy Updates,
• Important Community Announcements, and more!

It only takes a minute to refresh your details, and it helps us stay connected and continue supporting you throughout 2026!

If you have questions or need assistance, please reach out to us at updates@haea.org or 866-798-5598.

Update your HAEA membership HERE!

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Don’t miss the latest HAEA news and announcements, connect with us on social media!

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The HAEA is an advocacy and research organization committed to actively engaging our community in a wide variety of grassroots activities that promote HAE education and awareness. We provide personalized services to address the unique needs of people with HAE and their families, which includes helping them secure access to and reimbursement for modern HAE medicines. Our great success in supporting clinical research has resulted in a variety of FDA-approved therapeutic options. We work closely with expert physicians to continuously upgrade our community’s quality of life through improving diagnosis and knowledge of the condition, and encourage an individualized approach to selecting an optimal treatment. The HAEA is product and company neutral and continues to enthusiastically support drug discovery research aimed at the next generation of HAE therapies. Copyright © (2026) US Hereditary Angioedema Association All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, mechanical, electronic, photocopying, recording, or otherwise without the prior written permission of the US Hereditary Angioedema Association. For information, send an email to info@haea.org.