Participate in Hereditary Angioedema (HAE) research of DAWNZERA™ (donidalorsen)

The INSPIRE-D Study is an observational research effort sponsored by Ionis Pharmaceuticals. This study is designed to understand how DAWNZERA™ (donidalorsen) impacts the health and daily life of individuals living with Hereditary Angioedema (HAE) in real-world settings and routine care, beyond the clinical trial experience.

By joining, you'll help advance medical knowledge of HAE and support research into how treatment affects attack frequency, disease progression, safety, and overall well-being over time. The medical records PicnicHealth collects may help improve care, guide treatment decisions, and lead to a better future for people affected by HAE.

By participating, you'll contribute to important research that helps the HAE community while earning compensation and getting free access to your organized medical records. Your participation requires no clinic visits or extra procedures—just sharing records you already have and completing short surveys.

Joining the INSPIRE-D Study is completely optional. If you choose to participate, your medical care and your ability to access DAWNZERA™ will not be affected.

When you enroll in the INSPIRE-D Study, you cannot be participating in another HAE or DAWNZERA™ trial. However, it does not exclude you from participating in other PicnicHealth studies that are not related to HAE.

You may be eligible to participate in the study if you:

• Have a confirmed diagnosis of HAE
• Are 18 years of age or older
• You are currently taking DAWNZERA™ (started on or after September 1, 2025) or plan to start it within the next 60 days
• Reside and receive care in the U.S., including Puerto Rico
• Are able to read and understand English

Additionally, you must not be currently participating in a HAE clinical trial or have started DAWNZERA™ in the OASIS trial. You must also complete your Baseline Surveys within 30 days of signing your consent.

Ionis Pharmaceuticals makes DAWNZERA™ and wants to understand how it performs in real-world settings outside of clinical trials. This study will help Ionis gather long-term safety and effectiveness data, understand how doctors prescribe it and learn how the medication impacts patients' daily lives, quality of life, and healthcare needs. This information helps improve treatment options and care for the HAE community.

Ionis will use the study data in a de-identified and aggregated form to better understand the real-world effectiveness and safety of DAWNZERA™. The findings may be shared through scientific publications, conference presentations, and study reports to help inform doctors, researchers, and patients about treatment outcomes.

Your individual identity will not be shared in any publications or reports.

• You’ll review and sign a one-time online consent form.
• Once enrolled, PicnicHealth will collect your medical records directly from your doctors.
• Complete short surveys every 3 months about your quality of life and treatment experience.
• Log all symptoms and angioedema attacks as they happen, plus a monthly check-in via an eDiary.
• (Optional) Wear a Fitbit to track health metrics during angioedema attacks.

Only de-identified information is shared with the research team. Your name, contact information, and other identifying details are removed before your data is used for research. PicnicHealth follows strict privacy and security protocols and does not share your information for marketing or other non-research purposes.

Yes, surveys are a required part of the study and are very important. When you sign up for the study (sign consent), you will have 5 surveys to complete, which are estimated to take you 20 minutes in total to complete. We ask that you complete all of these on the same day, if possible, of your signed consent. After you’ve completed these initial surveys, you'll be asked to complete shorter questionnaires every 3 months for up to two years to help researchers understand your quality of life, treatment experience, and how HAE affects your daily life. You’ll also be asked to complete short electronic diary (e-diary) entries monthly and as needed to track angioedema attacks and related symptoms. You will receive compensation for your time completing these activities.

No, wearing a Fitbit is completely optional. If you choose to participate in the wearable portion of the study, you will receive a Fitbit at no cost. The device will track health metrics like heart rate, skin temperature, and sleep to help researchers explore whether wearable devices can detect early warning signs of angioedema attacks and changes that occur during an attack. You can participate in the study without wearing a Fitbit. ​​If you opt to receive a Fitbit, you may keep it at the conclusion of the study.

If you currently use a different type of device (like an Apple Watch or Garmin), you’re still welcome to join this part of the study — but we do ask that you wear the Fitbit provided to you for this study during the day and night so we can collect consistent health metrics data.

Yes. You'll receive approximately $120 for participating, depending on the completion of the surveys, eDiary completions, and time wearing Fitbit (optional), The e-gift card can be claimed online from your PicnicHealth dashboard. You'll also get a free PicnicHealth account that allows you to view and manage your own medical records online for the duration of the study. 

Compensation is redeemable once we confirm that you meet the eligibility criteria for the study, and once your eligibility is confirmed, the card will be emailed to you from GiftBit. Usually, this process takes 1-3 weeks, depending on how quickly we retrieve your medical records.

The study lasts for 2 years from the time you enroll. During this time, PicnicHealth will continue collecting your medical records, and you'll complete quarterly surveys and monthly diary entries. Medical records collected during the study may continue to be securely stored and used for research even if you withdraw, but no new information will be collected after you leave. You can withdraw at any time if you choose.

Yes. Participation is voluntary, and you can withdraw at any time. If you do, no new records will be collected, though information already shared can still be used for research. For details about withdrawing your study consent, including details about the surveys and data collection, please reach out to PicnicHealth at help@picnichealth.com or call (415) 680-3085.

PicnicHealth is a leading health technology company simplifying healthcare for everyone and a partner selected by Ionis Pharmaceuticals to support the INSPIRE-D Study. 

PicnicHealth collects and organizes your medical records, providing you with easy access to prepare for doctor visits and advocate for yourself. For this study, PicnicHealth ensures that relevant health data is accurately captured and shared with the research team in a secure, de-identified format—meaning your name and personal information are removed before researchers access anything. This enables researchers to analyze real-world outcomes without compromising your privacy.

We’ll start by searching for any of your records through our connected network of healthcare facilities that can release your records electronically. If necessary, direct requests can also be sent to your healthcare providers. Electronic records available through our connected network can be available within an hour, while records from direct requests may take a couple of weeks.

PicnicHealth will never share your records without your explicit consent. By signing up for this study, you're agreeing to share your de-identified data with Ionis for the purpose of inclusion in or informing the registry, the INSPIRE-D Study. Outside of that, no one will be able to see your medical records unless you choose to share them by clicking "Send Records" at the top of the PicnicHealth timeline.

You will be the only person who can access your medical records on PicnicHealth. No one — including your doctor or insurance company — will be able to see your medical records unless you choose to share them by clicking "Send Records" at the top of the PicnicHealth timeline.

PicnicHealth follows HIPAA-compliant practices and uses advanced end-to-end encryption and security measures, the same technology banks use to keep information secure. Your records are only shared with your permission.

No, there is no cost to participate in the INSPIRE-D Study. You’ll receive free access to PicnicHealth for the duration of the study. During this time, your medical records will be collected, digitized, and organized in a secure timeline you can view anytime.

Participation in this study does not provide DAWNZERA™ at a discounted rate or change how you access your medication. You should continue to work with your healthcare provider and pharmacy for all treatment-related decisions.

After the study ends, you’ll keep all your records. If you want PicnicHealth to continue updating your timeline, you can choose to subscribe at a discounted rate.

For more details or assistance regarding the PicnicHealth platform and medical record services, visit our website or reach out to the PicnicHealth team at inspired@picnichealth.com call at (415) 680-3085.