Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-05 @ 6:45 PM
Study NCT ID:
NCT05535933
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase II: overall Hb response rate', 'timeFrame': '24Weeks', 'description': 'Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24'}], 'secondaryOutcomes': [{'measure': 'Phase III: Durable Hb response rate', 'timeFrame': '24Weeks', 'description': 'Phase III: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Warm Antibody Autoimmune Hemolytic Anemia']}, 'referencesModule': {'references': [{'pmid': '39799953', 'type': 'DERIVED', 'citation': 'Zhao X, Sun J, Zhang Z, Chen M, Gong T, He G, Li Y, Liu H, Li F, Li X, Zhou H, Wang X, Hong M, Lei L, Yin H, Luo X, Li Y, Fan S, Guo X, Shi MM, Su W, Zhang L, Han B, Zhang F. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025 Feb;12(2):e97-e108. doi: 10.1016/S2352-3026(24)00344-2. Epub 2025 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA\n\nPhase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA', 'detailedDescription': 'Phase II Study: the proportion of patients with overall Hb response by Week 24\n\nPhase III study: the proportion of patients who achieve a durable response by Week 24'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form (ICF);\n2. Males or females aged 18 to 75 years;\n3. Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;\n4. Organs in good function.\n\nExclusion Criteria:\n\n1. Patients with other types of AIHA other than wAIHA;\n2. Patients with secondary wAIHA with unstable underlying disease;\n3. Patients with drug-induced secondary wAIHA;\n4. Patients with infections requiring systemic treatment;\n5. Patients previously treated with Syk inhibitors (e.g., fostamatinib);\n6. Patients with known allergy to the active ingredients or excipients of the study drug;\n7. Patients with serious psychological or mental disorder;\n8. Alcoholic or drug abuser;\n9. Female patients who are pregnant and lactating.'}, 'identificationModule': {'nctId': 'NCT05535933', 'acronym': 'wAIHA', 'briefTitle': 'HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia', 'orgStudyIdInfo': {'id': '2022-523-00CH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HMPL-523', 'description': 'Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment.\n\nPhase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.', 'interventionNames': ['Drug: HMPL-523(300mg PO QD)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment.\n\nPhase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HMPL-523(300mg PO QD)', 'type': 'DRUG', 'otherNames': ['Sovleplenib'], 'description': 'HMPL-523(300mg PO QD)', 'armGroupLabels': ['HMPL-523']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo(300mg PO QD)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liansheng Zhang', 'role': 'CONTACT'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Li', 'role': 'CONTACT'}], 'facility': 'The First affiliated hospital of nanchang uiversity', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sujun Gao', 'role': 'CONTACT'}], 'facility': 'Bethune First Hospital Of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bing Han', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengkui Zhang', 'role': 'CONTACT'}], 'facility': 'Hematology Hospital of Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Angela Niu', 'role': 'CONTACT', 'email': 'angelan@hutch-med.com', 'phone': '18801196102', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Fengkui Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'offices director'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The results of this study can be published in core journals or international scientific conferences, and the primary investigators who make significant contributions to the implementation and management of this study and the personnel who makes great contributions to the design, interpretation or analysis of this study (such as the staffs or consultants of the sponsor) can have their authorship attribution. The sponsor promises to provide the manuscript to the investigator for review before publication of any result of the study. Investigators have to obtain the approval of the sponsor before submitting academic articles or abstracts. The study personnel have the right to publish results of this study, however, the requirement of protecting confidential information must be met.\n\nThe confidential information is the property of the sponsor only, cannot be disclosed to others without the written approval of the sponsor, and cannot be used for other purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchison Medipharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}