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Study purpose

The HAE CHAPTER-3 Study is evaluating the efficacy and safety of an investigational drug called deucrictibant compared with placebo for prophylaxis to prevent hereditary angioedema (HAE) attacks in adults and adolescents with HAE.

Deucrictibant and the placebo are both given in the form of tablets that will be taken orally once daily. The participants will be randomized 2:1 to receive either deucrictibant or the placebo. If a participant experiences an HAE attack, they will be able to use their standard-of-care on‑demand HAE medication.

Study periods

Participation in the HAE CHAPTER-3 Study may last up to 9 months. This includes a screening period (up to 10 weeks), a treatment period (24 weeks), and a follow-up period (up to 4 weeks). Participants will have some visits on-site at the study clinic, while other visits may be performed 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).

Participants who complete the 24-week treatment period in the study may be eligible for the extension study called the HAE CHAPTER-4 Study, which will continue to evaluate deucrictibant.

About deucrictibant

Deucrictibant is an orally bioavailable small-molecule bradykinin B2 receptor antagonist with high therapeutic potential. Currently, most of the effective approved prophylactic treatments for HAE are subcutaneous injections or intravenous infusions, with one oral treatment. HAE patients have expressed the desire for more oral treatment options.

In people with HAE, 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, avoid progression of attack symptoms, and lead to the prevention of attacks.

Key eligibility criteria

Inclusion criteria

  • Male or female patients ages 12 years or older at screening
  • Have a diagnosis of HAE based on either of the following:
    • Confirmed diagnosis of HAE type 1, 2, or 3
    • Have a history of at least 3 HAE attacks within the 3 consecutive months prior to screening (or 3 months prior to commencing prophylactic treatment)
  • Have access and ability to use standard-of-care on‑demand HAE treatment to effectively manage HAE attacks
  • Be capable of recording data into an electronic diary (eDiary) daily

Exclusion criteria

  • Any female who is pregnant, plans to become pregnant, or is breastfeeding
  • Any diagnosis of angioedema other than HAE
  • Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of screening
  • Any clinically significant comorbidity or systemic dysfunction (e.g., cardiovascular, gastrointestinal, renal, neurological, respiratory) that, in the opinion of the investigator, would interfere with the participant’s safety or ability to participate in the study
  • Use of concomitant medications that are moderate and strong inhibitors/inducers of CYP3A4, such as clarithromycin, itraconazole, ketoconazole, and ritonavir within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization

Participants who previously completed the RAPIDe-3 Study may be eligible to be screened for this study. Additional eligibility criteria apply.

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