Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 4:57 PM
Study NCT ID:
NCT06072157
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2023-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind (placebo) essentially identical in appearance to the investigational drug (AK006)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single (Part A) and multiple (Part B) ascending IV dose study in healthy participants with a multiple dose expansion (Part C) in participants with chronic spontaneous urticaria. Single ascending (Part D) subcutaneous (SC) dose study in healthy participants'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2023-09-09', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Screening to Day 113 (Part A and D), Screening to Day 141 (Part B), and Screening to Day 197 (Part C)', 'description': 'AEs, serious AEs, and treatment emergent AEs (AE that starts after start of investigational product)'}, {'measure': 'Incidence of AEs of special interest', 'timeFrame': 'Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)', 'description': 'Infusion-related reactions, injection-related reactions, injection site reactions, anaphylaxis, and opportunistic infections'}, {'measure': 'AEs leading to discontinuation', 'timeFrame': 'Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)', 'description': 'AEs'}, {'measure': 'Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs', 'timeFrame': 'Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)', 'description': 'Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs'}], 'secondaryOutcomes': [{'measure': 'AK006 serum concentration at end of IV infusion', 'timeFrame': 'Day 1 (Part A) and Day 29 (Part B)', 'description': 'AK006 Serum concentration (ng/mL) at end of infusion'}, {'measure': 'AK006 area under the concentration-time curve (AUC) from time 0 to the time of last quantifiable concentration (AUC[0-last])', 'timeFrame': 'Day 1 to Day 113 (Part A and D) and Day 29 to Day 141 (Part B)', 'description': 'AK006 AUC(0-last) (ng x h/mL)'}, {'measure': 'AK006 AUC from time 0 extrapolated to infinity (AUC[0-inf])', 'timeFrame': 'Day 1 to Day 113 (Part A and D)', 'description': 'AK006 AUC(0-inf) (ng x h/mL)'}, {'measure': 'Total systemic clearance of AK006 after intravenous or subcutaneous dose (CL)', 'timeFrame': 'Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)', 'description': 'AK006 CL (L/h/kg)'}, {'measure': 'Systemic steady-state volume of distribution (Vss) of AK006', 'timeFrame': 'Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)', 'description': 'AK006 Vss (mg/L)'}, {'measure': 'AK006 Terminal elimination phase half-life (t1/2)', 'timeFrame': 'Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)', 'description': 'AK006 t1/2 (hours)'}, {'measure': 'Predose AK006 serum concentration (Ctrough, before the next dose) (Part B)', 'timeFrame': 'Day 29 (pre-dose)', 'description': 'AK006 Ctrough (ng/mL)'}, {'measure': 'AK006 AUC(0-last) after the second dose (Part B)', 'timeFrame': 'Day 29 to Day 141', 'description': 'AK006 AUC(0-last) (ng x h/mL)'}, {'measure': 'AK006 AUC over the dosing time interval (time 0 to 28 days) (AUC[tau]) (Part B)', 'timeFrame': 'Day 1 to Day 28 with each dosing interval', 'description': 'AK006 AUC(tau) (ng x h/mL)'}, {'measure': 'AK006 serum concentrations', 'timeFrame': 'Up to Day 141 (Part A, B, D); Up to Day 197 (Part C)', 'description': 'AK006 ng/mL'}, {'measure': 'AK006 absolute bioavailability subcutaneous injection', 'timeFrame': 'Day 1 to Day 113 (Part A and D)', 'description': 'Ratio of mean AUC(0-last) after subcutaneous injection to mean AUC(0-last) after intravenous administration adjusted for dose'}, {'measure': 'AK006 PK dose proportionality (Part A, B, D)', 'timeFrame': 'Up to Day 141', 'description': 'Comparing dose-normalized Cmax and AUC (Part A, B, and D)'}, {'measure': 'AK006 PK dose stationarity (Part B)', 'timeFrame': 'Up to Day 141', 'description': 'Comparing AUCtau from last dose to AUCtau from first dose'}, {'measure': 'AK006 Anti-drug Antibodies (ADAs)', 'timeFrame': 'Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B) and Day 1 to Day 197 (Part C)', 'description': 'Number of participants with positive or negative AK006-ADAs'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Chronic Spontaneous Urticaria']}, 'referencesModule': {'references': [{'pmid': '37413923', 'type': 'BACKGROUND', 'citation': "O'Sullivan JA, Youngblood BA, Schleimer RP, Bochner BS. Siglecs as potential targets of therapy in human mast cell- and/or eosinophil-associated diseases. Semin Immunol. 2023 Sep;69:101799. doi: 10.1016/j.smim.2023.101799. Epub 2023 Jul 4."}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. The study will be conducted in 4 parts: a single-ascending dose part (Part A) in healthy participants, a multiple-ascending dose part (Part B) in healthy participants with an expanded cohort (Part C) in participants with chronic spontaneous urticaria (CSU), and a single ascending dose SC injection cohort (Part D) in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nTo be included in the study, the participant must:\n\n* Weigh between 60 and 120 kg (inclusive) and have a body mass index (BMI) between 20 and 32 kg/m2, inclusive\n* Agree (female of childbearing potential or male with female partner of childbearing potential) to use a highly effective method (\\<1% failure rate) of birth control, if sexually active from screening and for 16 weeks after the last dose of investigational product (IP).\n\nAdditionally, to be included in Part A, B and D, the participant must:\n\n• Be in good general health with no significant medical history and has no clinically significant abnormalities on physical examination\n\nAdditionally, to be included in Part C, the participant must:\n\n* Have a diagnosis of chronic spontaneous urticaria (CSU) for at least 6 months prior to screening\n* Has a diagnosis of moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-AH between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following:\n\n * Presence of hives and itch for ≥6 consecutive weeks at any time prior to the Screening, despite the use of non-sedating H1-AHs. Note: Subject must be on a non-sedating H1-AH for treatment of CSU symptoms at the time of the Screening visit.\n * UAS7 score ≥16 with a HSS7 score ≥8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-AH.\n* Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study.\n* Able and willing to complete a daily electronic diary to collect CSU symptoms for the duration of the study.\n\nKey Exclusion Criteria:\n\nA participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:\n\n* Female participants who are pregnant, lactating, or planning to become pregnant during the study.\n* Abnormal laboratory values, or findings in physical examination, ECG (QTc \\>450 ms for males and \\>470 ms for females), or vital signs considered to be clinically significant by the investigator.\n\nAdditionally, a participant will be excluded from Part A, B and D, if:\n\n• Received treatment with any prescribed (excluding hormonal contraceptives or hormone replacement therapy \\[post-menopausal females\\]) or nonprescribed systemic or topical medication (including herbal product, and vitamins) within 21 days prior to the first dose of IP (excluding acetaminophen).\n\nAdditionally, a participant will be excluded from Part C, if:\n\n* Has known or suspected urticarial vasculitis\n* Subject has causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria\n* Subject has other conditions or diseases that in the investigator's opinion might influence study evaluations and results\n* Has any disease or condition (medical or surgical) which, in the opinion of the investigator, or medical monitor, would place the subject at increased risk"}, 'identificationModule': {'nctId': 'NCT06072157', 'briefTitle': 'Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allakos Inc.'}, 'officialTitle': 'A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AK006 in Healthy Subjects and in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria', 'orgStudyIdInfo': {'id': 'AK006-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A - Single Ascending Dose (SAD) Intravenous Cohorts', 'description': 'Part A: Healthy adult participants will receive a single intravenous infusion of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 5 cohorts evaluated.', 'interventionNames': ['Drug: AK006-IV', 'Drug: Placebo-IV']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - Multiple Ascending Dose (MAD) Intravenous Cohorts', 'description': 'Part B: Healthy adult participants will receive multiple intravenous infusions of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 3 cohorts evaluated.', 'interventionNames': ['Drug: AK006-IV', 'Drug: Placebo-IV']}, {'type': 'EXPERIMENTAL', 'label': 'Part C - Multiple Dose Intravenous Cohort', 'description': 'Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.', 'interventionNames': ['Drug: AK006-IV', 'Drug: Placebo-IV']}, {'type': 'EXPERIMENTAL', 'label': 'Part D - Single Ascending Dose (SAD) Subcutaneous Cohorts', 'description': 'Part D: Healthy adult participants will receive a single subcutaneous injection of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 2 cohorts evaluated.', 'interventionNames': ['Drug: AK006-SC', 'Drug: Placebo-SC']}], 'interventions': [{'name': 'AK006-IV', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['Part A - Single Ascending Dose (SAD) Intravenous Cohorts', 'Part B - Multiple Ascending Dose (MAD) Intravenous Cohorts', 'Part C - Multiple Dose Intravenous Cohort']}, {'name': 'Placebo-IV', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['Part A - Single Ascending Dose (SAD) Intravenous Cohorts', 'Part B - Multiple Ascending Dose (MAD) Intravenous Cohorts', 'Part C - Multiple Dose Intravenous Cohort']}, {'name': 'AK006-SC', 'type': 'DRUG', 'description': 'Subcutaneous', 'armGroupLabels': ['Part D - Single Ascending Dose (SAD) Subcutaneous Cohorts']}, {'name': 'Placebo-SC', 'type': 'DRUG', 'description': 'Subcutaneous', 'armGroupLabels': ['Part D - Single Ascending Dose (SAD) Subcutaneous Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 601-001 Healthy Volunteer Clinical Research Unit (Part A, B and D)', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site 601-004 (Part C)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 601-008 (Part C)', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Site 601-014 (Part C)', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Site 601-007 (Part C)', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Site 601-015 (Part C)', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Site 601-016 (Part C)', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site 601-006 (Part C)', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Site 601-019 (Part C)', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 601-003 (Part C)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site 601-012 (Part C)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 601-023 (Part C)', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site 601-011 (Part C)', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Site 601-020 (Part C)', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Site 601-017 (Part C)', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 601-002 (Part C)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Site 601-018 (Part C)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '79912', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 601-010 (Part C)', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '53228', 'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Site 601-013 (Part C)', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'zip': 'T2M 1A6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Site 601-106 (Part C)', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6H 5L5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Site 601-103 (Part C)', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L2H 1H5', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Site 601-107 (Part C)', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'M5G 1E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Site 601-108 (Part C)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Site 601-102 (Part C)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Site 601-105 (Part C)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allakos Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}