Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-03 @ 5:18 AM
Study NCT ID:
NCT01614756
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests', 'timeFrame': 'Up to 16 weeks after single dose'}], 'secondaryOutcomes': [{'measure': 'The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time', 'timeFrame': '13 timepoints upto 16 weeks after single dose'}, {'measure': 'Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments', 'timeFrame': 'Up to 16 weeks after single dose', 'description': 'The Immunogenicity of BMS-981164 will be assessed by this ADA assessments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects and Atopic Dermatitis Subjects']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine safety and tolerability of IL-31 mAB', 'detailedDescription': 'Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)\n\nEnrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Part 1: Healthy subjects\n* Part 2: Adult subjects with:\n\n 1. Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5\n 2. Pruritus severity of at least 7 of 10 on a visual analog scale\n\nExclusion Criteria:\n\n* Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration'}, 'identificationModule': {'nctId': 'NCT01614756', 'briefTitle': 'A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'IM134-002'}, 'secondaryIdInfos': [{'id': '2012-001865-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.1 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.01 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.03 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.06 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.1 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 0.3 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 1 mg/kg solution subcutaneously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 1 mg/kg solution intravenously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 3 mg/kg solution intravenously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo', 'description': 'Part 1\n\nSingle dose of BMS-981164 10.0 mg/kg solution intravenously\n\nOR\n\nSingle dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation- BMS-981164 or Placebo (dose group 1)', 'description': 'Part 2\n\nBMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose\n\nOR\n\nPlacebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation- BMS-981164 or Placebo (dose group 2)', 'description': 'Part 2\n\nBMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose\n\nOR\n\nPlacebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation- BMS-981164 or Placebo (dose group 3)', 'description': 'Part 2\n\nBMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose\n\nOR\n\nPlacebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation- BMS-981164 or Placebo (dose group 4)', 'description': 'Part 2\n\nBMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and \\>1.0mg/kg, once, single dose\n\nOR\n\nPlacebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose', 'interventionNames': ['Biological: BMS-981164', 'Biological: Placebo matching with BMS-981164']}], 'interventions': [{'name': 'BMS-981164', 'type': 'BIOLOGICAL', 'otherNames': ['IL-31 mAB'], 'armGroupLabels': ['Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo', 'Dose Escalation- BMS-981164 or Placebo (dose group 1)', 'Dose Escalation- BMS-981164 or Placebo (dose group 2)', 'Dose Escalation- BMS-981164 or Placebo (dose group 3)', 'Dose Escalation- BMS-981164 or Placebo (dose group 4)', 'Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo', 'Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo', 'Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo', 'Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo']}, {'name': 'Placebo matching with BMS-981164', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo', 'Dose Escalation- BMS-981164 or Placebo (dose group 1)', 'Dose Escalation- BMS-981164 or Placebo (dose group 2)', 'Dose Escalation- BMS-981164 or Placebo (dose group 3)', 'Dose Escalation- BMS-981164 or Placebo (dose group 4)', 'Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo', 'Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo', 'Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo', 'Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo', 'Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M15 6SH', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'M6 8HD', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}