Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT02985593
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627613', 'term': 'KHK4083'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature', 'timeFrame': 'Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}], 'secondaryOutcomes': [{'measure': 'Serum KHK4083 concentration', 'timeFrame': 'Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}, {'measure': 'Maximum concentration (Cmax) of KHK4083', 'timeFrame': 'Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}, {'measure': 'Time to reach Cmax (tmax) of KHK4083', 'timeFrame': 'Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}, {'measure': 'Area under the curve (AUC) of KHK4083', 'timeFrame': 'Part1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}, {'measure': 'Anti-KHK4083 antibody production', 'timeFrame': 'art1: Up to 18 weeks post drug administration, Part2: Up to 22 weeks post drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Men and Subjects With Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an open-label study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '"Part1:\n\nInclusion Criteria:\n\n1. Voluntary written informed consent to participate in the study;\n2. Japanese or White men ≥20 and \\<45 years at the time of informed consent;\n\nExclusion Criteria:\n\n1. Current illness requiring treatment;\n2. Current respiratory, gastric, renal, or liver disease;\n\nPart2:\n\nInclusion Criteria:\n\n1. Voluntary written informed consent to participate in the study;\n2. Men or women ≥20 years of age at the time of informed consent;\n3. Ulcerative colitis diagnosed ≥6 months prior to informed consent;\n4. Moderate or more severe ulcerative colitis;\n\nExclusion Criteria:\n\n1. Definitive diagnosis of bacillary dysentery, amebic colitis, Salmonella enteritis, Campylobacter enteritis, colonic tuberculosis, Chlamydia enteritis, Crohn\'s disease, radiation colitis, drug-induced colitis, angiolymphoid hyperplasia, ischemic colitis, or intestinal Behcet\'s disease;\n2. Any of the following clinically significant concurrent illnesses:\n\n * Type 1 diabetes\n * Poorly controlled type 2 diabetes (HbA1c \\>8.5%)\n * Congestive heart failure (class II to IV of the New York Heart Association classification)\n * Myocardial infarction within 1 year\n * Unstable angina pectoris within 1 year\n * Poorly controlled hypertension (systolic pressure \\>150 mmHg or diastolic pressure \\>90 mmHg at screening)\n * Severe chronic lung diseases requiring oxygen therapy\n * Multiple sclerosis or other demyelinating diseases\n * Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma);\n3. Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 2);\n4. Suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data within 1 year prior to enrollment; suspected or confirmed toxic megacolon or history of toxic megacolon; history of any colonic resection, subtotal or total colectomy, ileostomy, or colostomy; or any previous surgery for ulcerative colitis or an anticipated requirement for surgery for ulcerative colitis;\n5. Known colonic dysplasia, adenomas, or polyposis (excluding benign polyposis);\n6. Any planned surgical treatment during the study;\n7. Clostridium difficile infection within 8 weeks prior to enrollment;\n8. Any active infection, including Grade ≥2 localized diseases per Common Terminology Criteria for Adverse Events, version 4.0, Japan Clinical Oncology Group edition (CTCAE v4.0-JCOG), within 4 weeks prior to enrollment;\n9. Treatment with 5-aminosalicylic acid (5-ASA) enema, 5-ASA suppository, steroid enema, or steroid suppository within 2 weeks prior to enrollment;\n10. Treatment with adalimumab within 2 weeks prior to enrollment or treatment with infliximab within 8 weeks prior to enrollment;'}, 'identificationModule': {'nctId': 'NCT02985593', 'briefTitle': 'A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis', 'orgStudyIdInfo': {'id': '4083-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KHK4083', 'description': 'IV/SC administration', 'interventionNames': ['Drug: KHK4083']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV/SC administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KHK4083', 'type': 'DRUG', 'armGroupLabels': ['KHK4083']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}