Actively Recruiting
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Led by Institute for Asthma and Allergy · Updated on 2025-07-02
10
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Male or female aged 18 years or older at consent.
- Diagnosis of bradykinin-mediated angioedema based on clinical history without response to antihistamines, corticosteroids, or omalizumab.
- Tried and failed at least 2 weeks of cetirizine 20 mg twice daily or equivalent antihistamines.
- Elevated blood bradykinin peptide levels after 3 days cold activation during attack or non-attack periods.
- Normal C1 inhibitor antigen concentration and functional activity, and normal C4 antigen concentration.
- History of at least 2 angioedema attacks in the last 2 months.
- Reliable access and experience using standard care medication for acute angioedema attacks.
You will not qualify if you...
- Any diagnosis of angioedema other than BK-AE-nC1INH.
- Participation in another investigational drug study within 30 days or 5 half-lives before screening.
- Use of ACE inhibitors or systemic estrogen-containing medications within 4 weeks before screening.
- Receiving prophylactic treatment for BK-AE-nC1INH or short-term prophylaxis within 7 days before screening.
- Pregnant, planning pregnancy, or breastfeeding females.
- Abnormal liver function tests (AST >2x ULN, ALT >2x ULN, total bilirubin >1.5x ULN) except Gilbert's syndrome.
- Abnormal kidney function (eGFR <60 mL/min/1.73 m²).
- Significant cardiovascular disease within the past year that may affect safety or participation.
- History of epilepsy or significant neurological diseases.
- Significant gastrointestinal dysfunction affecting drug absorption.
- History of alcohol or drug abuse in the past year or current dependence.
- Use of moderate or strong CYP3A4 inhibitors or inducers within 30 days or 5 half-lives before randomization.
- Known allergy to deucrictibant or any study drug ingredients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute For Asthma & Allergy
Wheaton, Maryland, United States, 20902
Actively Recruiting
Research Team
H
Henry Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
4
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