Institute for Asthma and Allergy
To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.
Study Design: The study has 2-parts, studying the efficacy of deucrictibant versus placebo for prophylactic and on-demand treatment of angioedema attacks will be assessed in adult participants with BK-AE-nC1INH. Each part of the study is designed a randomized, double-blind, placebo-controlled cross-over trial. Up to 10 patients to be enrolled. Deucrictibant has been adopted as the international nonproprietary name (INN) for the active ingredient, previously referred to as PHA121 or PHA-022121. Deucrictibant is under development as an orally administered bradykinin B2 receptor antagonist with…
Inclusion Criteria: 1. Provision of written informed consent. 2. Male or female, aged ≥18 at the time of provision of informed consent. 3. Diagnosis of bradykinin-mediated angioedema based upon all of the following: * Clinical history consistent with angioedema (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria), not responsive to treatments of anti-histamine, corticosteroid, and/or omalizumab. * Tried and failed at least 2 weeks of cetirizine 20 mg twice a day (or its equivalent alternative antihistamines, such as fexofenadine, loratadine, desloratadine or l…
Deucrictibant 40 mg XR tablet for prophylaxis
Placebo comparator to deucrictibant 40 mg XR tablet, prophylaxis
Deucrictibant active drug for on-demand treatment of angioedma attacks
Placebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks
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