Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT04175704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-03
First Post:
2019-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in 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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients', 'timeFrame': '99 days', 'description': '1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Idiopathic Urticaria']}, 'descriptionModule': {'briefSummary': 'The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.', 'detailedDescription': 'This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged ≥ 18 years\n* Subjects who are able and willing to provide the informed consent\n* Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.\n\nExclusion Criteria:\n\n* History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT04175704', 'briefTitle': 'Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'United BioPharma'}, 'officialTitle': 'A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria', 'orgStudyIdInfo': {'id': 'UBP-A115-IgE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort 1', 'description': '0.2 mg/kg UB-221 or placebo', 'interventionNames': ['Drug: UB-221']}, {'type': 'OTHER', 'label': 'Cohort2', 'description': '0.6 mg/kg UB-221 or placebo', 'interventionNames': ['Drug: UB-221']}, {'type': 'OTHER', 'label': 'Cohort 3', 'description': '2 mg/kg UB-221 or placebo', 'interventionNames': ['Drug: UB-221']}, {'type': 'OTHER', 'label': 'Cohort 4', 'description': '6 mg/kg UB-221 or placebo', 'interventionNames': ['Drug: UB-221']}], 'interventions': [{'name': 'UB-221', 'type': 'DRUG', 'otherNames': ['recombinant anti-IgE humanized IgG1 monoclonal antibody'], 'description': 'Name: UB-221 Active ingredient: Anti-IgE monoclonal antibody Dosage form: UB-221 drug product is presented as a sterile liquid for intravenous (IV) infusion. Each vial contains 75 mg/mL UB-221 in 1.12 mL of buffered solution', 'armGroupLabels': ['Cohort 1', 'Cohort 3', 'Cohort 4', 'Cohort2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mico Hsu, Master', 'role': 'CONTACT', 'email': 'mico.hsu@unitedbiopharma.com', 'phone': '+886-3-668-4800', 'phoneExt': '3201'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United BioPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}