Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT04035135
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label combination treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's", 'timeFrame': '6 months', 'description': "As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation."}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of ANX005 when administered in combination with IVIg', 'timeFrame': '3 months', 'description': 'As measured by ANX005 serum concentrations'}, {'measure': 'Pharmacodynamics of ANX005 when administered in combination with IVIg', 'timeFrame': '4 months', 'description': 'As measured by CH50 and C1q serum concentrations'}, {'measure': 'Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit', 'timeFrame': '6 months', 'description': 'The 6-point Guillain-Barré Syndrme Disability Score (GBS-DS) is a widely accepted and easily obtainable scoring system used to assess functional status of GBS subjects. The score is as follows: 0 = Healthy, 1 = Minor symptoms and capable of running, 2 = Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4 = Bedridden or chair bound, 5 = Needing mechanical ventilation, 6 = death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Guillain-Barré Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.', 'detailedDescription': 'The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome\n* Onset of GBS-related weakness ≤14 days prior to infusion\n* GBS-DS score of 3, 4, or 5\n\nExclusion Criteria:\n\n* Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data\n* Be at risk of suicide or self-harm\n* Received previous treatment with plasma exchange for GBS\n* Any diagnosis of a variant of GBS\n* Have a history of anaphylaxis or severe systemic response to immunoglobulin\n* Documented, clinically significant, pre-existing polyneuropathy from another cause\n* Clinically significant intercurrent illness, medical condition, or medical history\n* History of chronic use of steroid or immunosuppressant medication\n* Active alcohol, drug, or substance abuse\n* Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study'}, 'identificationModule': {'nctId': 'NCT04035135', 'briefTitle': 'A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Annexon, Inc.'}, 'officialTitle': 'A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome', 'orgStudyIdInfo': {'id': 'ANX005-GBS-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label Treatment Arm', 'description': 'One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days.', 'interventionNames': ['Drug: ANX005', 'Drug: Intravenous immunoglobulin']}], 'interventions': [{'name': 'ANX005', 'type': 'DRUG', 'otherNames': ['Anti C1q Antibody'], 'description': 'investigational drug', 'armGroupLabels': ['Open Label Treatment Arm']}, {'name': 'Intravenous immunoglobulin', 'type': 'DRUG', 'otherNames': ['IVIg'], 'description': 'investigational drug', 'armGroupLabels': ['Open Label Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'National Institute of Neurosciences and Hospital', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Henk-André Kroon, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Annexon, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annexon, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ResearchPoint Global', 'class': 'OTHER'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}