Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-13 @ 12:53 AM
Study NCT ID:
NCT02418104
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the immunogenicity of CHS-1701 compared to Neulasta', 'timeFrame': '84 days', 'description': 'The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response'}], 'secondaryOutcomes': [{'measure': 'Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t)', 'timeFrame': '84 days'}, {'measure': 'Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)', 'timeFrame': '84 days'}, {'measure': 'Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, and local injection site reactions (ISRs)', 'timeFrame': '84 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Immunity, Humoral']}, 'referencesModule': {'references': [{'pmid': '35034311', 'type': 'DERIVED', 'citation': "Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16."}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult male or female of ages 18 to 50 inclusive\n2. Body weight \\> 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive\n3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination\n4. Negative urine pregnancy test in women of childbearing potential\n\nExclusion Criteria:\n\n1. Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)\n2. Chemistry and hematology values outside protocol specified range\n3. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder\n4. History of chronic or acute respiratory illness within the past 4 weeks\n5. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation\n6. No prescription or nonprescription drugs during the study\n7. Participation in an investigational clinical study within 30 days prior to screening\n8. Known or suspected allergic reaction to latex'}, 'identificationModule': {'nctId': 'NCT02418104', 'briefTitle': 'Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coherus Oncology, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta® in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CHS-1701-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHS-1701', 'description': 'CHS-1701 followed by CHS-1701', 'interventionNames': ['Drug: CHS-1701']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neulasta', 'description': 'Neulasta followed by Neulasta', 'interventionNames': ['Drug: Pegfilgrastim (Neulasta)']}], 'interventions': [{'name': 'CHS-1701', 'type': 'DRUG', 'armGroupLabels': ['CHS-1701']}, {'name': 'Pegfilgrastim (Neulasta)', 'type': 'DRUG', 'otherNames': ['Neulasta'], 'armGroupLabels': ['Neulasta']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince & Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Spaulding Clinical', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}], 'overallOfficials': [{'name': 'Barbara Finck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coherus Oncology, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coherus Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}