Development and construct validation of the angioedema quality of life questionnaire.
K Weller, A Groffik, M Magerl...
https://pubmed.ncbi.nlm.nih.gov/22913638Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID07046806
Oral Deucrictibant for Prophylactic and Acute Treatment in Patients With Bradykinin-Mediated Angioedema With Normal C1 Inhibitor
Led by Institute for Asthma and Allergy · Updated on 2025-07-02
10
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of deucrictibant, an oral bradykinin B2 receptor antagonist, for both preventing and treating acute angioedema attacks in adults with bradykinin-mediated angioedema with normal C1 inhibitor (BK-AE-nC1INH). The study involves a randomized, double-blind, placebo-controlled crossover design to compare deucrictibant with placebo for long-term prophylaxis and on-demand treatment during attacks. This trial includes up to 10 participants and aims to assess both symptom prevention and relief. The study has two parts. Part 1 tests deucrictibant extended-release (XR) tablets at a dose of 40 mg once daily versus placebo for 12 weeks each, with participants crossing over after the first 12 weeks for a total of 24 weeks. Part 2 begins after Part 1 and evaluates deucrictibant 20 mg soft capsules versus placebo for on-demand treatment of two angioedema attacks over approximately 16 weeks. Participants self-administer the study drug or placebo during qualifying attacks and record treatment and symptoms in a diary. Participants will keep detailed diaries to track angioedema symptoms, treatments, and responses throughout the study. Researchers will assess the number and quality of angioedema attacks during prophylaxis and symptom relief during acute treatment. Safety will be monitored through adverse event tracking, lab tests, vital signs, physical exams, and ECGs. The total participation duration can be up to 40 weeks, including screening, treatment, and follow-up visits.
CONDITIONS
Brief Title
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Provision of written informed consent
- Male or female, aged 18 years or older at the time of consent
- Diagnosis of bradykinin-mediated angioedema with clinical history consistent with angioedema not responsive to antihistamines, corticosteroids, or omalizumab
- Tried and failed at least 2 weeks of cetirizine 20 mg twice daily or equivalent antihistamines
- Total blood bradykinin peptide levels above diagnostic value following 3 days cold activation
- Documented normal C1INH antigen concentration and functional activity; normal C4 antigen concentration
- History of at least 2 angioedema attacks in the previous 2 months
- Reliable access and experience to use standard on-demand angioedema medication
You will not qualify if you...
- Diagnosis of angioedema other than BK-AE-nC1INH
- Participation in another investigational drug study within 30 days or 5 half-lives prior to screening
- Use of ACE inhibitors or estrogen-containing systemic medications within 4 weeks of screening
- Receiving prophylactic treatment for BK-AE-nC1INH or short-term prophylaxis within 7 days prior to screening
- Female participants who are pregnant, planning pregnancy, or breastfeeding
- Abnormal liver function tests beyond set limits (except Gilbert's syndrome)
- Abnormal kidney function with eGFR less than 60 mL/min/1.73 m2
- Significant cardiovascular disease within the previous year
- History of epilepsy or significant neurological diseases
- Significant gastrointestinal dysfunction affecting drug absorption
- History of alcohol or drug abuse within the past year
- Use of moderate or strong CYP3A4 inhibitors or inducers within 30 days or 5 half-lives prior to randomization
- Known allergy to deucrictibant or any study drug excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks (12 weeks on each treatment)
Participants take deucrictibant or placebo tablets once daily for prophylaxis against angioedema attacks in a randomized, double-blind crossover design.
Visits at start and end of each 12-week treatment period
Treatment
Duration - Up to 16 weeks
Participants self-administer deucrictibant or placebo capsules on-demand at home to treat up to 2 angioedema attacks in a randomized, double-blind crossover design.
Study visits at Week 24 and within 7±2 days after second treated attack
Follow-up
Duration - Approximately 28 days
Participants attend an end-of-study visit approximately 28 days after the second treated attack for safety and efficacy assessments.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Institute For Asthma & Allergy
Wheaton, Maryland, United States, 20902
Actively Recruiting
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Research Team
H
Henry Li, MD
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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Published Research Related To This Trial
Hereditary Angioedema With Normal C1 Inhibitor: US Survey of Prevalence and Provider Practice Patterns.
Marc A Riedl, Mark Danese, Sherry Danese...
https://pubmed.ncbi.nlm.nih.gov/36720386Randomized placebo-controlled trial of the bradykinin B₂ receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial.
William R Lumry, H Henry Li, Robyn J Levy...
https://pubmed.ncbi.nlm.nih.gov/22123383