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New treatment option for Hereditary Angioedema (HAE)
Official title Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
ClinicalTrials.gov ID: NCT07046806
What this study is testing
What is Deucrictibant XR tablet?
Deucrictibant XR tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hereditary angioedema (hae).
Also referred to as Deucrictibant XR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Provision of written informed consent.
- Male or female, aged ≥18 at the time of provision of informed consent.
- 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...
- Tried and failed at least 2 weeks of cetirizine 20 mg twice a day (or its equivalent alternative antihistamines, such as fexofenadine, loratadine...
You likely can't join if
- Any diagnosis of angioedema other than BK-AE-nC1INH.
- Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug...
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral...
- Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in...
- Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.
- Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
See the full eligibility criteria
- Provision of written informed consent.
- Male or female, aged ≥18 at the time of provision of informed consent.
- 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.
- Documented history of at least 2 angioedema attacks in the previous 2 months.
- Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.
- Any diagnosis of angioedema other than BK-AE-nC1INH.
- 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).
- 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.
- 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)...
- Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.
- Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
- 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...
- Abnormal renal function (estimated glomerular filtration rate [eGFR] \<60 mL/min/1.73 m2).
- Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant...
- History of epilepsy and other significant neurological diseases.
- Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption.
- History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
- 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...
- Known hypersensitivity to deucrictibant or any of the excipients of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Wheaton, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wheaton, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.