Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03447704
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718740', 'term': 'netakimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASAS40 rate at Week 16', 'timeFrame': 'Week 16', 'description': 'Percentage of patients with ASAS40 response after 16 weeks of therapy (percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40%)'}], 'secondaryOutcomes': [{'measure': 'ASAS20 rate', 'timeFrame': 'Week 4, 8, 12, 16, 24, 36, 52', 'description': 'Percentage of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20%'}, {'measure': 'Change from baseline in BASDAI', 'timeFrame': 'Week 4, 8, 12, 16, 24, 36, 52', 'description': 'Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score in comparison with screening (from 0 to 10). The maximum change is considered to be better outcome'}, {'measure': 'Change from baseline in ASDAS-CRP', 'timeFrame': 'Week 4, 8, 12, 16, 24, 36, 52', 'description': 'Change in ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score Index) score in comparison with screening (from 0 to \\> 3.5). The maximum change is considered to be better outcome'}, {'measure': 'Change from baseline in SF-36', 'timeFrame': 'Week 16, 36, 52', 'description': 'Change in SF-36 (The Short Form-36) score in comparison with screening (physical component) (from 15.9 to 62.1). The maximum change is considered to be better outcome'}, {'measure': 'Frequency of AE/SAE', 'timeFrame': 'Week 60', 'description': 'Percentage of patients with AE (adverse events) /SAE (serious adverse events)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing Spondylitis', 'interleukin 17', 'monoclonal antibody', 'netakimab'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '36062743', 'type': 'RESULT', 'citation': 'Mazurov VI, Dubinina TV, Erdes S, Lapshina SA, Soroka NF, Kunder EV, Smirnov AV, Eremeeva AV, Zinkina-Orikhan AV, Morozova MA, Gaydukova IZ. Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. Clin Exp Rheumatol. 2023 Mar;41(3):718-726. doi: 10.55563/clinexprheumatol/ljpqqe. Epub 2022 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'BCD-085-5 is an International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-5 trial patients with active ankylosing spondylitis will receive 120 mg of BCD-085 subcutaneously every other week or placebo up to Week 16. Starting from week 16 all patients will receive BCD-085. Efficacy, PK and safety parameters will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.\n* Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.\n* Mean backache intensity equals 4 points or more.\n\nExclusion Criteria:\n\n* Total spinal ankylosis.\n* Previous treatment with anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.\n* Prior use of \\>2 biologics to tumor necrosis factor alfa.\n* Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.\n* Prior use of alkylating agents for up to 12 months prior to signing informed consent.'}, 'identificationModule': {'nctId': 'NCT03447704', 'briefTitle': 'International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Patients With Active Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'BCD-085-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-085 (netakimab)', 'interventionNames': ['Drug: BCD-085']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'BCD-085', 'type': 'DRUG', 'otherNames': ['netakimab'], 'description': '120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week', 'armGroupLabels': ['BCD-085 (netakimab)']}, {'name': 'placebo', 'type': 'OTHER', 'description': '2 ml of placebo subcutaneously at week 0,1 2 and every other week, starting from week 16 - 120 mg of BCD-085 subcutaneously at week 16,17 and 18 every other week', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '355047', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical hospital', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Kazan State Medical University', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Omsk', 'country': 'Russia', 'facility': 'Omsk Regional Clinical Hospital', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'LLC BioEk', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'North-Western State Medical University n.a. I.I.Mechnikov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Roman Ivanov, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'JSC BIOCAD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}