Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06182969
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726452', 'term': 'Lisaftoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in the number and percentages of immune cells clusters.', 'timeFrame': 'Up to 1 year', 'description': 'The changes of immune cell clusters from baseline.'}, {'measure': 'Change in the number and percentages of cytokines.', 'timeFrame': 'Up to 1 year', 'description': 'The changes of cytokines from baseline.'}], 'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.', 'timeFrame': 'Up to 1 year', 'description': 'According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.', 'timeFrame': 'At Day1 and Day 28 since the first dose of study drug.', 'description': 'To evaluate the metabolic characteristics of APG-2575 in SLE patients'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.', 'timeFrame': 'At Day1 and Day 28 since the first dose of study drug.', 'description': 'To evaluate the metabolic characteristics of APG-2575 in SLE patients'}, {'measure': 'Time to Peak (Tmax) of APG-2575 in SLE patients.', 'timeFrame': 'At Day1 and Day 28 since the first dose of study drug.', 'description': 'To evaluate the metabolic characteristics of APG-2575 in SLE patients'}, {'measure': 'Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.', 'timeFrame': 'Up to 1 year', 'description': "To evaluate the patients' efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLE', 'APG-2575'], 'conditions': ['SLE']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Diagnosis of systemic lupus erythematosus for at least 6 months.\n* 2\\. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.\n* 3\\. SLEDIA-2000 score: 4-12\n* 4.Other than systemic lupus erythematosus, subject should be in general good health.\n\nExclusion Criteria:\n\n* 1\\. Severe systemic lupus erythematosus.\n* 2\\. Significant autoimmune disease other than lupus.\n* 3\\. Significant, uncontrolled or unstable disease in any organ.'}, 'identificationModule': {'nctId': 'NCT06182969', 'briefTitle': 'A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascentage Pharma Group Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.', 'orgStudyIdInfo': {'id': 'APG2575SC101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APG-2575', 'description': 'Dose escalation', 'interventionNames': ['Drug: APG-2575']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'APG-2575', 'type': 'DRUG', 'description': 'Take orally once daily (QD) for 12 weeks.', 'armGroupLabels': ['APG-2575']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Take orally once daily (QD) for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng Chen, Ph.D', 'role': 'CONTACT', 'email': '13917556052@139.com', 'phone': '13917556052'}, {'name': 'Sheng Chen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renji Hospital Shanghai Jiaotong University School of Medical', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yifan Zhai', 'role': 'CONTACT', 'email': 'Yzhai@ascentage.com', 'phone': '240-505-6608'}, {'name': 'Xiaofeng Han', 'role': 'CONTACT', 'email': 'Xiaofeng.Han@ascentage.com'}], 'overallOfficials': [{'name': 'Sheng Chen, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascentage Pharma Group Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Suzhou Yasheng Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}