Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients

Launched by INSTITUTE FOR ASTHMA AND ALLERGY · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medicine called deucrictibant to help people with hereditary angioedema (HAE), a rare condition that causes sudden swelling in different parts of the body. The study aims to find out if taking deucrictibant regularly can prevent these swelling attacks and if taking it during an attack can quickly relieve symptoms. Participants will either receive deucrictibant or a placebo (a pill with no active medicine) to compare the effects.

Adults aged 18 and older who have been diagnosed with a specific type of angioedema caused by a buildup of a substance called bradykinin, and who have had at least two swelling attacks in the last two months, may be eligible. To join, participants need to have tried other common allergy medicines without success and have certain blood test results that support the diagnosis. During the study, participants will take the study medicine either daily to prevent attacks or as needed to treat attacks, and they will be closely monitored. People who are pregnant, have certain health problems, or are taking certain medications will not be eligible. This trial is currently recruiting, so if you or a loved one fits the criteria, it might be an opportunity to try a new treatment for managing hereditary angioedema.

Gender

ALL

Eligibility criteria

• 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 levocetirizine, etc.).
• • Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and/or attack period\*.
• • \*The "attack period" is defined as within 24 hours after an attack.
• • 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.
• Exclusion Criteria:
• • 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:
• • • Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.
• • 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.