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Study design

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 deucrictibant and placebo. This includes a screening period, a Day 1 visit/non-attack 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.

Deucrictibant and the placebo are both given in the form of softgel capsules, which will be taken orally, according to a participant’s assigned order. The participants will be randomly assigned to receive them in 1 of 2 orders: deucrictibant first and then the placebo or the placebo first and then deucrictibant. If the study drug does not provide sufficient symptom relief during an HAE attack, the participant may contact their study doctor again to discuss how they feel and determine if they should take a second dose of the study drug. However, if needed, the participant may use their own prescribed HAE medication or study-provided icatibant.

Eligibility criteria

Eligible participants must:

• Be male or female between 12 and 75 years at screening
• Have a diagnosis of HAE 1/2 based upon all of the following:
  • Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria)
  • At least 1 of the following:
    • Age ≤ 30 years at reported onset of first angioedema symptoms
    • Family history consistent with HAE-1/2
    • C1q above the lower limit of the normal range
  • Diagnostic testing results to confirm HAE-1/2:
    • Participants on long-term prophylactic HAE therapies with C1-INH or danazol at the time of study entry must provide documentation of a historical laboratory test showing C1-INH functional level < 50%
    • For all other participants, C1-INH functional level of < 50% must be shown by chromogenic assay performed by the central laboratory as part of the screening procedures
• Have a history of at least 2 HAE attacks 3 months prior to screening
• 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 intend 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
• Have experience using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks
• If a participant is receiving long-term prophylactic therapy with 1 of the following medications (plasma-derived C1-INH, danazol at ≤ 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab), they must be on a stable dose and regimen for at least 6 months before screening and intend to remain on the same dose for the duration of the study
• Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device
• Not have any diagnosis of angioedema other than HAE-1/2
• Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and contraceptive requirements