[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharvaris Netherlands B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":20},"100613454","phase-3-study-of-oral-deucrictibant-xr-tablet-for-prophylaxis-and-deucrictibant-ir-capsule-for-on-demand-treatment-of-angioedema-attacks-in-adults-with-acquired-angioedema-due-to-c1-inhibitor-deficiency-100613454",false,"NCT07266805","Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency","A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency","CREAATE","Inclusion Criteria:\n\n* Provision of written informed consent\n* Male or female (sex at birth) aged ≥18 years\n* Diagnosis of AAE-C1INH\n* History of AAE-C1INH attacks prior to the Screening Visit:\n* Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH\n\n  * The underlying condition can reasonably be expected to remain stable for the duration\n* Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks.\n* Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method.\n\nFemales of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.\n\n• Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.\n\nExclusion Criteria:\n\n* Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).\n* Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit\n* Any females who are pregnant, plan to become pregnant, or are currently breast-feeding\n* Abnormal hepatic function\n* Moderate or severe renal impairment\n* Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.\n* History of epilepsy and\u002For other significant neurological diseases\n* Any clinically significant and uncontrolled gastrointestinal dysfunction that may impact study drug absorption\n* Evidence of current alcohol or drug abuse\n* Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit\n* Known hypersensitivity to deucrictibant or any of the excipients of the study drug\n* Use of angiotensin-converting enzyme inhibitors or any estrogen-containing medications","ALL","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.",[27],"Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Acquired Angioedema-C1-INH","AAE-C1-INH","Oral Treatment","deucrictibant","Prophylaxis","On-demand","C1-Inhibitor Deficiency","PHA121","Pharvaris","Bradykinin B2 Receptor Antagonists","Angioedema","Acquired","Acquired angioedema","RECRUITING","2026-06-26",{"date":45,"type":46},"2026-06-29","ACTUAL",{"date":48,"type":46},"2025-10-16",{"date":50,"type":21},"2027-06",{"name":52,"class":53},"Pharvaris Netherlands B.V.","INDUSTRY",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100568335","phase-3-long-term-open-label-study-of-oral-deucrictibant-extended-release-tablet-for-prophylaxis-against-angioedema-attacks-in-adolescents-and-adults-with-hae-100568335","NCT06679881","Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE","A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema","CHAPTER-4","Inclusion Criteria:\n\n1. Provision of the signed ICF by the participant and\u002For legally designated representative.\n2. Male or female, aged ≥12 years at the time of providing written informed consent\u002Fassent.\n3. Diagnosis of hereditary angioedema (HAE)\n4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening\n5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.\n6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.\n7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.\n\nExclusion Criteria:\n\n1. Any diagnosis of angioedema other than HAE\n2. Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at ICF signature (whichever is longer)\n3. Prior gene therapy for any indication at any time\n4. Participants who discontinued from previous studies with deucrictibant prophylactic and\u002For on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study\n5. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening\n6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis\n7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding\n8. Abnormal hepatic function\n9. Moderate or severe renal impairment\n10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.\n11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse\n12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 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 the study drug","12 Years",{"count":64,"type":21},170,[24],"This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema",[68],"Hereditary Angioedema (HAE)",[70,31,38,71,36,72,33],"HAE","PHVS719","Deucrictibant","2026-05-06",{"date":75,"type":46},"2026-05-07",{"date":77,"type":46},"2025-02-01",{"date":79,"type":21},"2028-12",{"name":52,"class":53},62,""]