Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
NCT07046806 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-07-02
Summary
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.
Conditions
- Hereditary Angioedema (HAE)
- Angioedema
- Bradykinin-mediated Angioedema
- C1 Inhibitor Deficiency
Interventions
- DRUG
-
Deucrictibant XR tablet
Deucrictibant 40 mg XR tablet for prophylaxis
- DRUG
-
Placebo comparator to XR tablet
Placebo comparator to deucrictibant 40 mg XR tablet, prophylaxis
- DRUG
-
Deucrictibant 20 mg capsule
Deucrictibant active drug for on-demand treatment of angioedma attacks
- DRUG
-
Placebo comparator to 20 mg capsule
Placebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks
Sponsors & Collaborators
-
Institute for Asthma and Allergy
lead NETWORK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-10
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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