RECRUITING

Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients

Conditions

Hereditary Angioedema (HAE)Angioedema Bradykinin-mediated Angioedema C1 Inhibitor Deficiency Bradykinin deucrictibant HAE BK-AE-nC1INH nC1INH C1 Inhibitor C4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)

Quick Facts

Study Start:2025-03-10

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07046806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 levocetirizine, etc.). * Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and/or attack period\. Documented diagnostic testing results: C1INH antigen concentration and functional activity within normal range; C4 antigen concentration within normal range. 4. Documented history of at least 2 angioedema attacks in the previous 2 months. 5. Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.	1. Any diagnosis of angioedema other than BK-AE-nC1INH. 2. Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug at Screening (whichever was longer). 3. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening. 4. Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in this study provided a sufficiently long washout period (≥5 half-life) is observed before the participant is screened. Exclusion includes use of: 5. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding. 6. Abnormal hepatic function (aspartate aminotransferase \>2× upper limit of normal, alanine aminotransferase \>2× ULN, or total bilirubin \>1.5× upper limit of normal). Participants with Gilbert's syndrome, defined as isolated increase of total bilirubin ≤3× upper limit of normal and aspartate aminotransferase and alanine aminotransferase within the normal range, are not excluded. 7. Abnormal renal function (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m2). 8. Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant cardiovascular abnormality within the previous year that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study. 9. History of epilepsy and other significant neurological diseases. 10. Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption. 11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse. 12. Use of concomitant medications with systemic absorption that are moderate and strong inhibitors or strong inducers of CYP3A4, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, and grapefruit juice as well as carbamazepine, and rifampin within the last 30◦days or within 5◦half-lives (whichever is longer) of the time of randomization. 13. Known hypersensitivity to deucrictibant or any of the excipients of study drug.

Inclusion Criteria

Exclusion 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 levocetirizine, etc.).
* Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and/or attack period\*.
* Documented diagnostic testing results: C1INH antigen concentration and functional activity within normal range; C4 antigen concentration within normal range.
4. Documented history of at least 2 angioedema attacks in the previous 2 months.
5. Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.

1. Any diagnosis of angioedema other than BK-AE-nC1INH.
2. Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug at Screening (whichever was longer).
3. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening.
4. Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in this study provided a sufficiently long washout period (≥5 half-life) is observed before the participant is screened. Exclusion includes use of:
5. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
6. Abnormal hepatic function (aspartate aminotransferase \>2× upper limit of normal, alanine aminotransferase \>2× ULN, or total bilirubin \>1.5× upper limit of normal). Participants with Gilbert's syndrome, defined as isolated increase of total bilirubin ≤3× upper limit of normal and aspartate aminotransferase and alanine aminotransferase within the normal range, are not excluded.
7. Abnormal renal function (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m2).
8. Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant cardiovascular abnormality within the previous year that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study.
9. History of epilepsy and other significant neurological diseases.
10. Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption.
11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
12. Use of concomitant medications with systemic absorption that are moderate and strong inhibitors or strong inducers of CYP3A4, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, and grapefruit juice as well as carbamazepine, and rifampin within the last 30◦days or within 5◦half-lives (whichever is longer) of the time of randomization.
13. Known hypersensitivity to deucrictibant or any of the excipients of study drug.

Contacts and Locations

Study Contact

Henry Li, MD

CONTACT

301-962-5800

info@allergyasthma.us

Study Locations (Sites)

Institute For Asthma & Allergy

Wheaton, Maryland, 20902

United States

Collaborators and Investigators

Sponsor: Institute for Asthma and Allergy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

Bradykinin
deucrictibant
HAE
BK-AE-nC1INH
nC1INH
C1 Inhibitor
C4

Additional Relevant MeSH Terms

Hereditary Angioedema (HAE)
Angioedema
Bradykinin-mediated Angioedema
C1 Inhibitor Deficiency