Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT05396105
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-23
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}, {'id': 'D056829', 'term': 'Hereditary Angioedema Types I and II'}, {'id': 'D056828', 'term': 'Hereditary Angioedema Type III'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent Adverse Events (TEAEs), treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), treatment-related TESAEs, and TEAEs leading to deucrictibant discontinuation', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).'}, {'measure': 'Heart Rate', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).', 'description': 'Descriptive in nature, no formal statistical hypothesis testing will be performed.'}, {'measure': 'Blood pressure', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).', 'description': 'Systolic and diastolic blood pressure will be measured. Descriptive in nature, no formal statistical hypothesis testing will be performed.'}, {'measure': 'Body temperature', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).', 'description': 'Descriptive in nature, no formal statistical hypothesis testing will be performed.'}, {'measure': 'Clinical laboratory tests', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).', 'description': 'hematology, blood chemistry, urinalysis'}, {'measure': 'Electrocardiograms', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).'}, {'measure': 'Physical Examination', 'timeFrame': 'From enrollment through study completion, up to 54 months (dependent on time of enrollment).'}], 'secondaryOutcomes': [{'measure': 'Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment', 'timeFrame': 'Assessed from 1 hour to 12 hours post-treatment', 'description': 'PGI-C evaluates the change in the attack symptoms over time with a 7-point response scale.'}, {'measure': 'Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment', 'timeFrame': 'Assessed from 1 hour to 12 hours post-treatment', 'description': 'PGI-C evaluates the change in the attack symptoms over time with a 7-point response scale.'}, {'measure': 'Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S), defined as achieving ≥1 point reduction in PGI-S from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment', 'timeFrame': 'Assessed from pre-treatment to 12 hours post-treatment', 'description': 'PGI-S evaluates the severity of attack symptoms with a 5-point response scale.'}, {'measure': 'Time to onset of symptom relief by VAS-3/VAS-5 (Part A) or AMRA (Part B), defined as a reduction of ≥30% from pretreatment in VAS/AMRA composite score, sustained for 2 consecutive timepoints)', 'timeFrame': 'Assessed from pre-treatment to 48 hours post-treatment', 'description': 'VAS scores range between 0 and 100. A larger reduction means a better outcome.'}, {'measure': 'Time to symptom relief by VAS (Part A) or AMRA (Part B), based on achieving ≥50% reduction from pretreatment in VAS/AMRA composite score sustained for 2 consecutive timepoints.', 'timeFrame': 'Assessed from pre-treatment to 48 hours post-treatment', 'description': 'VAS/AMRA scores range between 0 and 100. A larger reduction means a better outcome.'}, {'measure': 'Proportion of deucrictibant-treated attacks requiring rescue medication within 24 hours post-treatment', 'timeFrame': 'Assessed from pre-treatment to 24 hours post-treatment'}, {'measure': 'Proportion of deucrictibant-treated attacks with almost complete or complete symptom relief by VAS-3/ VAS-5/ AMRA through 24 hours post-treatment', 'timeFrame': 'Assessed from pre-treatment to 24 hours post-treatment', 'description': 'Almost complete or complete symptom relief is defined as all individual item scores in VAS/AMRA having a value ≤10 sustained for 2 consecutive timepoints.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HAE', 'HAE Type I', 'HAE Type II', 'Oral Treatment', 'Bradykinin B2 Receptor Antagonists', 'On-Demand', 'PHA121', 'PHVS416', 'PHA-022121', 'Deucrictibant', 'HAE Type III'], 'conditions': ['Hereditary Angioedema', 'Hereditary Angioedema Type I', 'Hereditary Angioedema Type II', 'Hereditary Angioedema Types I and II', 'Hereditary Angioedema Attack', 'Hereditary Angioedema With C1 Esterase Inhibitor Deficiency', 'Hereditary Angioedema - Type 1', 'Hereditary Angioedema - Type 2', 'C1 Esterase Inhibitor [C1-INH] Deficiency', 'C1 Esterase Inhibitor Deficiency', 'C1 Esterase Inhibitor, Deficiency of', 'C1 Inhibitor Deficiency', 'Hereditary Angioedema Type III', 'Hereditary Angioedema (HAE)', 'Hereditary Angioedema Type I and II']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll patients from Study PHA022121-C201 (NCT04618211) and Study PHA022121-C306 (NCT06343779) who elect to participate in this extension study and meet the eligibility requirements.', 'detailedDescription': 'Part A of the study will enroll adult participants from Study PHA022121-C201. The double-blind treatment assignment from Study PHA022121-C201 will be maintained.\n\nPart B will include participants rolling over from Part A and additionally enroll participants from Study PHA022121-C201 who did not participate in Part A, and participants from Study PHA022121-C306 who elect to participate in this extension study and meet the eligibility requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Provision of written informed consent. If the participant is a minor (i.e., \\<18 years of age or as determined by local law), consent will be obtained from the participant's parent/legally designated representative/guardian and written assent will be obtained from the participant, per country regulations.\n2. For participants from Study C201, received at least one dose of study drug (including the non-attack visit) in Study C201. For participants from Study C306, participant was randomized (and for adolescent participants 12 to \\<18 years received a dose of study drug in a non-attack state at Visit 1) and completed Study C306, with 2 attacks treated, or after closure of that study by the Sponsor.\n\n Enrollment of adolescents (≥12 to \\<18 years or age of adulthood as defined locally) from these studies is with consideration of local age requirements.\n3. Female participants of childbearing potential (or who become of childbearing potential during the study) must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method as defined in the protocol and as available locally from enrollment until 30 days after the last study drug administration.\n4. In the opinion of the Investigator, the participant (and parent/caregiver for adolescent participants) is willing and able to comply with the protocol.\n\nKey Exclusion Criteria:\n\n1. Any female who is pregnant, plans to become pregnant, or is breast-feeding.\n2. Any other systemic disease (e.g., cardiovascular, gastrointestinal, renal, respiratory, neurological) or significant disease or disorder that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study.\n3. Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior to enrollment in Part A.\n4. For Part A: Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment.\n\n For Part B: If a participant is receiving long-term prophylactic therapy with one of the following medications indicated for HAE: plasma-derived C1-INH, danazol at less than or equal to 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, they must be on a stable dose and regimen for at least 3 months before screening and intends to remain on the same dose for the duration of the study.\n5. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse\n6. Participation in any other investigational drug study within defined period\n7. Discontinued from parent study after enrollment for any study drug-related safety reason or non-compliance including significant protocol deviation.\n8. Use of concomitant medications that are strong CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or strong CYP3A4 inducers (e.g., carbamazepine and phenytoin)."}, 'identificationModule': {'nctId': 'NCT05396105', 'acronym': 'RAPIDe-2', 'briefTitle': 'Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharvaris Netherlands B.V.'}, 'officialTitle': 'A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema', 'orgStudyIdInfo': {'id': 'PHA022121-C303'}, 'secondaryIdInfos': [{'id': '2023-505766-28-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part B: Selected dose', 'description': 'Single dose of deucrictibant', 'interventionNames': ['Drug: deucrictibant selected dose']}], 'interventions': [{'name': 'deucrictibant selected dose', 'type': 'DRUG', 'otherNames': ['PHVS416', 'PHA121', 'PHA-022121'], 'description': 'deucrictibant soft capsule for oral use', 'armGroupLabels': ['Part B: Selected dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United 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