Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-27 @ 10:23 PM
Study NCT ID:
NCT04569435
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2025-01-02', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-24', 'dispFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Treatment-Emergent Adverse Events', 'timeFrame': 'Up to Week 36'}], 'secondaryOutcomes': [{'measure': 'Serum Concentrations of ANX005', 'timeFrame': 'Up to Week 36'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of ANX005', 'timeFrame': 'Up to Week 36'}, {'measure': 'Area Under the ANX005 Serum Concentration-Time Curve', 'timeFrame': 'Day 1 and Week 22'}, {'measure': 'Change from Baseline in Free Complement (C) 1q Serum Concentrations', 'timeFrame': 'Baseline, up to Week 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.', 'detailedDescription': 'In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS.\n\nThe study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of ALS according to the World Federation of Neurology revised EI Escorial criteria.\n* Onset of weakness within 3 years prior to Day 1 visit.\n* Slow Vital Capacity ≥ 50% of predicted normal adjusted for sex, age, and height (from the sitting position).\n* ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at the Screening visit (Week -2).\n* If female, must be postmenopausal, surgically sterilized, or childbearing potential must agree to use highly effective methods of contraception from Screening until 3 months after the last infusion with study medication.\n* Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening until Week until 3 months after the last infusion with study medication.\n* Documented history of vaccinations within 5 years prior to Screening visit against encapsulated bacterial pathogens or willing to undergo vaccinations.\n\nKey Exclusion Criteria:\n\n* Clinically significant intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the data derived from the participant.\n* Participants with body weight \\> 150 kilograms.\n* Antinuclear antibodies (ANA) titer ≥ 1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) during the Screening Period.'}, 'identificationModule': {'nctId': 'NCT04569435', 'briefTitle': 'Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Annexon, Inc.'}, 'officialTitle': 'Phase 2a Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Study of Intravenous ANX005 in Subjects With Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': 'ANX005-ALS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANX005', 'description': 'Participants will receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses of ANX005 every 2 weeks up to Week 22.', 'interventionNames': ['Drug: ANX005']}], 'interventions': [{'name': 'ANX005', 'type': 'DRUG', 'description': 'IV Infusion', 'armGroupLabels': ['ANX005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Annexon Investigational Site 04', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '9492868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Annexon Investigational Site 01', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Annexon Investigational Site 02', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Annexon Investigational Site 03', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': 'T6G 2R7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Annexon Investigational Site 10', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Annexon Investigational Site 09', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Annexon Investigational Site 07', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Annexon Investigational Site 08', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Benjamin Hoehn, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Annexon, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annexon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}