Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT07224360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double blind, placebo controlled study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)', 'timeFrame': 'From baseline up to Week 75'}, {'measure': 'Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP', 'timeFrame': 'From baseline up to Week 75'}, {'measure': 'Number of participants with Adverse Events of Special Interest (AESI)', 'timeFrame': 'From baseline up to Week 75', 'description': 'The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 3 or 4), severe infection and neutropenic fever.'}, {'measure': 'Percentage of participants with AESI', 'timeFrame': 'From baseline up to Week 75', 'description': 'The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever.'}, {'measure': 'Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs', 'timeFrame': 'From baseline up to Week 75'}, {'measure': 'Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs', 'timeFrame': 'From baseline up to Week 75'}], 'secondaryOutcomes': [{'measure': 'Serum concentration of Anumigilimab', 'timeFrame': 'From the first dose of anumigilimab to Week 65'}, {'measure': 'Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)', 'timeFrame': 'During the maintenance period from Week 13 to Week 65', 'description': 'VOC (medical facility) is defined as VOC that results in a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Genetic Disorder', 'Vaso-occlusive Crises'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': "This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.\n\nThe primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Adults aged greater than or equal to (\\>=) 18 years on the day of signing the informed consent form.\n* • Confirmed diagnosis of SCD of any genotype.\n* • Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening.\n* • HU Regimen:\n* a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.\n* or\n* b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).\n\nExclusion Criteria:\n\n* • Absolute neutrophil count less than (\\<) 2.5 ×10\\^9 cells/Litre at Screening or Baseline (Week 1 Day 1).\n* • If on SCD preventive medication, dose is not stable in the 30 days before Screening.'}, 'identificationModule': {'nctId': 'NCT07224360', 'briefTitle': 'Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'CSL324_2002'}, 'secondaryIdInfos': [{'id': '2025-521154-42-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anumigilimab', 'description': 'Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)', 'interventionNames': ['Biological: Anumigilimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching volume of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anumigilimab', 'type': 'BIOLOGICAL', 'description': 'Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.', 'armGroupLabels': ['Anumigilimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Volume matched saline will be administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Trial Registration Coordinator', 'role': 'CONTACT', 'email': 'clinicaltrials@cslbehring.com', 'phone': '+1 610-878-4697'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.', 'ipdSharing': 'YES', 'description': 'CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.', 'accessCriteria': 'Proposed research should seek to answer a previously unanswered important medical or scientific question.\n\nApplicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.\n\nIf the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}