[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596541":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":55,"centralContacts":56,"locations":62,"responsibleParty":81,"collaborators":55,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":55,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":65,"whyStopped":55,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Institute for Asthma and Allergy","NETWORK",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Deucrictibant XR tablet, 40 mg, prophylaxis","EXPERIMENTAL","Deucrictibant XR tablet, 40 mg, QD, oral use for 12 weeks",[13],"Drug: Deucrictibant XR tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo to deucrictibant XR tablet, 40 mg, prophylaxis","PLACEBO_COMPARATOR","Placebo tablets, 40 mg equivalent, QD, oral use for 12 weeks",[19],"Drug: Placebo comparator to XR tablet",{"label":21,"type":10,"description":22,"interventionNames":23},"On-demand deucrictibant 20 capsule, oral use","Single 20 capsule orally for treatment of on-demand angioedema attack, for up to 16 weeks",[24],"Drug: Deucrictibant 20 mg capsule",{"label":26,"type":16,"description":27,"interventionNames":28},"Placebo comparator to on-demand deucrictibant 20 capsule, oral use","Placebo capsules for treatment of on-demand angioedema attacks, for up to 16 weeks",[29],"Drug: Placebo comparator to 20 mg capsule",[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Deucrictibant XR tablet","Deucrictibant 40 mg XR tablet for prophylaxis",[9],[37],"Deucrictibant XR",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Placebo comparator to XR tablet","Placebo comparator to deucrictibant 40 mg XR tablet, prophylaxis",[15],[43],"Placebo",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Deucrictibant 20 mg capsule","Deucrictibant active drug for on-demand treatment of angioedma attacks",[21],[49],"Deucrictibant",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Placebo comparator to 20 mg capsule","Placebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks",[26],[43],null,[57],{"name":58,"role":59,"phone":60,"phoneExt":55,"email":61},"Henry Li, MD","CONTACT","301-962-5800","info@allergyasthma.us",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Institute For Asthma & Allergy","RECRUITING","Wheaton","Maryland","20902","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-77.05526,39.03983,{"lat":75,"lon":74},[78],{"name":79,"role":59,"phone":60,"phoneExt":55,"email":80},"Henry LI, MD, PhD","info@allergyasthma.gov",{"type":82,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100596541","phase-1-oral-deucrictibant-for-prophylactic-and-acute-treatment-in-hereditary-angioedema-patients-100596541",false,"NCT07046806","Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients","Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)","BK-AE-nC1INH","Inclusion Criteria:\n\n1. Provision of written informed consent.\n2. Male or female, aged ≥18 at the time of provision of informed consent.\n3. Diagnosis of bradykinin-mediated angioedema based upon all of the following:\n\n   * Clinical history consistent with angioedema (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria), not responsive to treatments of anti-histamine, corticosteroid, and\u002For omalizumab.\n   * 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.).\n   * Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and\u002For attack period\\*.\n\n     \\*The \"attack period\" is defined as within 24 hours after an attack.\n   * Documented diagnostic testing results: C1INH antigen concentration and functional activity within normal range; C4 antigen concentration within normal range.\n4. Documented history of at least 2 angioedema attacks in the previous 2 months.\n5. Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.\n\nExclusion Criteria:\n\n1. Any diagnosis of angioedema other than BK-AE-nC1INH.\n2. 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).\n3. 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.\n4. 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:\n\n   • Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.\n5. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.\n6. 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.\n7. Abnormal renal function (estimated glomerular filtration rate \\[eGFR\\] \\\u003C60 mL\u002Fmin\u002F1.73 m2).\n8. 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.\n9. History of epilepsy and other significant neurological diseases.\n10. Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption.\n11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.\n12. 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.\n13. Known hypersensitivity to deucrictibant or any of the excipients of study drug.","ALL","18 Years","75 Years",{"count":95,"type":96},10,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE1","PHASE2","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.",[103,104,105,106],"Hereditary Angioedema (HAE)","Angioedema","Bradykinin-mediated Angioedema","C1 Inhibitor Deficiency",[108,109,110,89,111,112,113],"Bradykinin","deucrictibant","HAE","nC1INH","C1 Inhibitor","C4","2025-06-23",{"date":116,"type":117},"2025-07-02","ACTUAL",{"date":119,"type":117},"2025-03-10",{"date":121,"type":96},"2026-04-01",{"name":5,"class":6},1]