For physicians

Study purpose

The RAPIDe-3 Study is evaluating the efficacy and safety of an oral study drug, called deucrictibant, compared to a placebo for the on-demand treatment of angioedema attacks in participants with HAE due to C-1-esterase inhibitor (C1-INH) deficiency (type 1 or type 2).

Study periods

Participation in the RAPIDe-3 Study will vary in duration based on how long it takes for a participant to experience and treat 2 qualifying HAE attacks with the study drug. This includes a screening period, a Day 1 visit, an attack treatment phase with a follow-up visit for the first qualifying HAE attack, and an end-of-study visit after a second qualifying HAE attack. Participants will have some visits on-site at the study clinic, while other visits may be performed remotely (where applicable and permitted by local regulations).

A few days after each HAE attack is treated with the study drug, participants will be required to take part in an interview conducted by telephone or teleconference (using an online communication platform such as Webex), whichever is more convenient for a participant.

Each interview will last approximately 1 hour.

About deucrictibant

There is an unmet need for oral medicines that can effectively treat HAE attacks. There are currently 2 approaches to HAE management: acute (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.

Most patients with HAE have a defect in the C1-inhibitor (C1-INH) gene leading to the activation of the kallikrein-kinin system and the release of bradykinin. Deucrictibant is a bradykinin B2 receptor antagonist. It is expected to reduce signs and symptoms of acute HAE attacks by inhibiting bradykinin signaling through the bradykinin B2 receptor.

Participants will be randomized to receive deucrictibant and a placebo in 1 of 2 orders: 1 group will receive deucrictibant first to treat the first HAE attack and then the placebo to treat the second HAE attack, and the other group will receive the placebo first and then deucrictibant. If the study drug does not provide sufficient symptom relief during an HAE attack, the participant may take a second dose of the study drug. If there is still no symptom relief following the second dose of study drug, participants may use their own prescribed HAE medication or study-provided icatibant.

Key eligibility criteria

Inclusion criteria

  • Male or female patients between 21 and 75 years at screening
  • Diagnosis of HAE-1/2
  • History of at least 2 HAE attacks 3 months prior to screening
  • Experience using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks
  • Either:
    • Is on a stable dose and regimen of long-term prophylactic therapy with 1 of the following medications indicated for HAE: plasma-derived C1-INH, danazol at ≤ 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, for at least 6 months before the screening visit and intends to remain on the same dose for the duration of the study

      OR

    • Is receiving only on-demand treatment and has not used long-term prophylactic treatment within the following durations before the screening visit, as specified below:
      • Plasma-derived C1-INH, berotralstat, anti-fibrinolytics, or attenuated androgens for at least 2 weeks
      • Lanadelumab for at least 10 weeks
  • Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device
  • Female participants of childbearing potential (or who become of childbearing potential during the study) must agree to the protocol-specified pregnancy testing and contraceptive requirements

Exclusion criteria

  • Any diagnosis of angioedema other than HAE-1/2
  • 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 with systemic absorption that are 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
  • Use of attenuated androgens for short-term prophylaxis within the past 30 days prior to the time of randomization
  • Any female who is pregnant, plans to become pregnant, or is breastfeeding

Other inclusion and exclusion criteria apply. For additional information, visit ClinicalTrials.gov (NCT06343779).

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