Join us as we take a closer look at a potential new therapeutic option for HAE

If you or your child is living with hereditary angioedema (HAE), you may be eligible to participate in the HAE CHAPTER-3 Study.

Learn more about the study

Find a participating site

Purpose of the HAE CHAPTER-3 Study

The HAE CHAPTER-3 Study is evaluating the efficacy and safety of an investigational once-daily oral drug called deucrictibant compared to a placebo (a substance that looks just like deucrictibant but contains no active medicine) as a new therapeutic option to prevent HAE attacks.

Who can join the study?

Diversity in clinical research is important. This study is looking to include individuals from different backgrounds to represent people of various gender, race, and ethnicity.

To be considered for participation in the HAE CHAPTER-3 Study, interested individuals must:

  • Be 12 years of age or older
  • Have a confirmed diagnosis of HAE
  • Have access, ability, and experience using standard-of-care on‑demand HAE treatment to manage HAE attacks

There are other requirements, which the study doctor will discuss with you.

About the HAE CHAPTER-3 Study

The HAE CHAPTER-3 Study is a clinical research study for children and adults living with HAE. Participants will be randomized to receive either deucrictibant or a placebo, with a higher chance of receiving deucrictibant. This is a phase 3 study, which means that deucrictibant has already been tested in other HAE clinical research studies before and has shown favorable results for efficacy and safety.

Deucrictibant and the placebo are both given in the form of tablets that will be taken orally once daily. If a participant experiences an HAE attack, they will be able to use their standard-of-care on‑demand HAE medication.

Participation in the HAE CHAPTER-3 Study will last up to nine months and have several visits. Some visits may be done virtually by phone or videoconference. Remote visits, where a home nurse visits the participant, are also possible (if allowed by hospital and local regulatory requirements).

The study will include three periods:

Screening (up to 10 weeks)

Time Commitment (approximate)

On-site screening visit: 1.5 hr.

Site phone calls: 5 min./week

eDiary entries: 2 min./day

To confirm eligibility for the study, potential participants will undergo a screening visit at the study site and complete a screening period of a maximum of 10 weeks to evaluate a participant’s HAE. During the screening period, participants will record their HAE attacks in an electronic diary (eDiary). Additionally, participants will have weekly phone calls with the research site. If eligibility is confirmed, the treatment period will start.

Treatment (24 weeks)

Time Commitment (approximate)

On-site visits: 1.5 hr. each

Virtual visits: 5 min. each

eDiary entries: 2 min./day

There will be on-site study and virtual visits that may be done by phone or videoconference. Remote visits, where a home nurse visits the participant, are also possible (if allowed by hospital and local regulatory requirements). For 24 weeks, participants will take their assigned study drug (deucrictibant or placebo) once daily around the same time every day and record the intake in the eDiary. If a participant has an HAE attack, they may take their standard-of-care on‑demand HAE medication.

  • The eDiary should be completed daily throughout the full duration of the study. These entries will be used to record:
    • Intake of the study drug
    • HAE attack occurrence
  • The eDiary will also be used to record:
    • Use of standard-of-care on‑demand HAE treatments
    • Questionnaires on HAE symptoms and how participants are feeling

Follow-up (up to four weeks)

Time Commitment (approximate)

On-site visit: 20 min.

OR

Virtual visit: 5 min.

eDiary entries: 2 min./day

After completing the treatment period, participants may be eligible to join an extension study called the HAE CHAPTER-4 Study. In the HAE CHAPTER-4 Study, all participants will receive deucrictibant daily at no cost to evaluate the effects of long-term use. There is no placebo in the HAE CHAPTER-4 Study.

For participants who join the HAE CHAPTER-4 Study, the four-week follow-up period for the HAE CHAPTER-3 Study may be waived.

Participants who will not join the HAE CHAPTER-4 Study will have an up to four-week follow-up period to check on their safety. This includes one end-of-study visit that happens up to four weeks after a participant’s last dose of the study drug. During this visit, the study team will perform final assessments to check on a participant’s health.

For more information, talk to your doctor or contact a participating research site.

The HAE CHAPTER-4 Study

The HAE CHAPTER-4 Study is evaluating the safety and efficacy of deucrictibant as a potential preventative treatment for HAE attacks when it’s taken as a daily tablet over a long period of time. This is an extension study, meaning all participants will receive deucrictibant.

The HAE CHAPTER-4 Study is a phase 3 extension study, which means that deucrictibant has already been tested in other HAE clinical research studies before and has shown favorable results for safety and efficacy.

Participation in the HAE CHAPTER-4 Study will last up to two and a half years, and there will be dedicated on-site visits. Some visits may be done virtually by phone or videoconference.

About the study drug

There is an unmet need for oral (taken by mouth) medicines that can effectively treat HAE attacks. There are currently two approaches to HAE management: on‑demand treatment of attacks and prevention of attacks (prophylactic therapy). This study is exploring the clinical effects of an investigational oral once-daily HAE medication to potentially prevent attacks.

Find a participating research site

Enter your zip code or click on the map to find the participating research site(s) nearest you. Please check back soon to see if a site in your area has been added.

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Active site locations

Future site locations

About hereditary angioedema

Hereditary angioedema (HAE) is a rare genetic condition, and the symptoms and frequency of attacks may vary from person to person. Some people may get a rash or experience a tingling sensation in a specific area of the body before their HAE attack. Generally, HAE attacks cause swelling of the skin, abdomen, and throat.

Minor stress or trauma may bring on an attack, but swelling often occurs without a known trigger. HAE is often initially misdiagnosed as an allergic reaction, but medications such as antihistamines don’t reduce the swelling associated with HAE attacks.

Reference

  1. haei.org/hae

Frequently asked questions (FAQs)

Clinical research studies, also called clinical trials, look at an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.

In most countries, the regulatory health authority, such as the Food and Drug Administration (FDA) in the United States, requires that several phases of clinical research be performed to better understand the safety and efficacy of new investigational drugs and certain medical devices.

Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time for any reason. Before leaving the study, participants should discuss this decision with the study doctor, who will give them information about how to do this safely.

Before an individual can take part in the HAE CHAPTER-3 Study, they will first need to complete the consent form and attend the screening visit(s) for initial tests and assessments to see if they are eligible to participate. After all necessary tests and assessments have been completed, and if an individual is eligible to participate, they may enter the study and receive the assigned study treatment (deucrictibant or placebo).

Participation in the HAE CHAPTER-3 Study will last up to nine months.

Find a participating site