One oral on‑demand treatment for HAE attacks

The RAPIDe-3 Study is currently enrolling participants who have been diagnosed with hereditary angioedema (HAE) type 1 or 2. This clinical research study is evaluating an investigational oral on-demand treatment that could help people who have swelling attacks due to HAE.

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Purpose of the RAPIDe-3 Study

The RAPIDe-3 Study is evaluating the efficacy and safety of an oral medication called deucrictibant compared with a placebo for on-demand treatment of HAE attacks.

Who can participate

Eligible participants must meet the following key inclusion criteria to join the RAPIDe-3 Study:

  • Be between 12 and 75 years of age
  • Have a confirmed diagnosis of HAE-1/2
  • Have had at least two HAE attacks within the past three months
  • Have had experience using standard-of-care treatment to manage on-demand treatment for HAE attacks

Other eligibility criteria apply.

About the RAPIDe-3 Study

Participation in the RAPIDe-3 Study will vary in duration based on how long it takes for a participant to experience and treat two qualifying HAE attacks with the study medication (either deucrictibant or placebo). Participation consists of the following parts:

Screening

Potential participants will undergo screening to confirm eligibility for the study. They will also receive training on the use of a study-provided handheld device to complete an HAE diary and electronic patient-reported outcome (ePRO) questionnaires.

Day 1 visit

If eligible, adolescent participants will get one dose of deucrictibant at this visit while in a non-attack state, followed by multiple blood draw sessions over the course of eight hours to see how their body is affected by the active study medication. Both adult and adolescent participants will be randomized to receive deucrictibant for the first HAE attack and the placebo for the second or the placebo for the first HAE attack and deucrictibant for the second.

Treatment phase: treatment of two qualifying HAE attacks

Upon experiencing symptoms of an HAE attack, participants will consult with their study doctor, who will determine if the participant should take the study medication. If the attack can be treated with the study medication, participants will answer a series of questionnaires on their handheld device before taking the study medication and at various time points thereafter, up to two days after treatment. The questionnaires will take approximately 2 to 3 minutes to complete each time.

  • Follow-up visits after each treated HAE attack: Following each HAE attack treated with the study medication, participants will have a study visit to check their health. Also, a one-hour interview will be conducted by telephone or teleconference within 10 days after each treated attack. The visit after the second attack treated with the study medication will also be the end-of-study visit.

The study medication and study-related assessments will be provided at no cost to participants. The study team will discuss with participants how they may be reimbursed for other study-related expenses, such as travel and meals.

After completing the RAPIDe-3 Study, participants may be eligible to join an open-label extension (OLE) study, called the RAPIDe-2 Study, to continue receiving deucrictibant to treat their acute HAE attacks at no cost. This OLE study is planned to continue until the availability of a commercial supply of deucrictibant or until another means of continued treatment can be provided.

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About deucrictibant

There is an unmet need for oral medicines with which to effectively treat HAE attacks. There are currently two approaches to HAE management: on-demand treatment of attacks and prevention of attacks with prophylactic therapy. This study is exploring the clinical effects of an investigational oral on-demand HAE medication.

In people with HAE-1/2, a low level of the C1-inhibitor in the blood causes an increased amount of a protein called bradykinin. This increase of bradykinin causes the painful symptoms of HAE swellings. Deucrictibant is designed to block the effects of bradykinin and avoid progression of attack symptoms, and leads to the resolution of attacks.

Participants will be randomized to receive deucrictibant and a placebo in one of two orders: deucrictibant for the first HAE attack, and the placebo for the second or the placebo for the first HAE attack, and deucrictibant for the second. A placebo is a substance that looks like deucrictibant but which contains no active ingredients.

Active site locations

Future site locations

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View the full list of locations to see if there’s a study site near you.

Participating research site(s)

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 epinephrine, glucocorticoids, and antihistamines don’t reduce the swelling associated with HAE attacks.

Reference: haei.org/hae

Frequently asked questions (FAQs)

Clinical research studies, also called clinical trials, look at an investigational medication 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 Medication Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union, requires that several phases of clinical research be performed to better understand the efficacy and safety of new investigational medications 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 securing the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and examinations 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 RAPIDe-3 Study, they will first need to 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 study medication.

Participation in the RAPIDe-3 Study will vary in duration based on how long it takes for a participant to experience and treat two qualifying HAE attacks with the study medication.

Find a participating site