Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 5:33 PM
Study NCT ID:
NCT07052032
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of treatment-emergent adverse events through end of study', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Changes from baseline in vital signs through end of study', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Changes from baseline in ECG parameters through end of study: PR interval', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Changes from baseline in ECG parameters through end of study: QRS interval', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Changes from baseline in ECG parameters through end of study: QTcF interval', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Changes from baseline in safety laboratory assessments through end of study', 'timeFrame': 'Baseline to Month 12'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) concentration-time profiles for CND261', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: maximum concentration', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: time of maximum concentration', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: area under the concentration-time curve', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: clearance', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: volume of distribution', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'PK parameters for CND261: half-life', 'timeFrame': 'Baseline to Month 12'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.', 'detailedDescription': 'This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND261 in patients with seropositive rheumatoid arthritis. The study consists of 2 parts: a dose-escalation part and an open-label expansion. Patients will be followed until Week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 75 years old\n2. Diagnosis of adult-onset RA\n3. Class I-III RA\n4. Moderately to severely active RA\n5. Inadequate treatment response as defined in the protocol\n6. Stable use of any concomitant therapies\n\nExclusion Criteria:\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. Receipt of live vaccine within 4 weeks\n5. Presence of any concomitant autoimmune disease\n6. Active or known history of catastrophic anti-phospholipid syndrome\n7. APS or thrombotic event not adequately controlled by anticoagulation therapy\n8. History of progressive multifocal leukoencephalopathy\n9. Central nervous system disease\n10. Presence of 1 or more significant concurrent medical conditions\n11. Have a diagnosis or history of malignant disease within 5 years\n12. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair ability to receive planned treatment or to understand informed consent\n13. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation\n14. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study\n15. Women who are pregnant or breastfeeding\n16. Patients who do not agree to the use of highly effective contraception as defined by the protocol'}, 'identificationModule': {'nctId': 'NCT07052032', 'briefTitle': 'An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Candid Therapeutics'}, 'officialTitle': 'A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of CND261 in Patients With Seropositive Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'CND261-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CND261', 'interventionNames': ['Biological: CND261']}], 'interventions': [{'name': 'CND261', 'type': 'BIOLOGICAL', 'description': 'CND261 will be dosed according to the assigned cohort', 'armGroupLabels': ['CND261']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ClinicalTrials@candidrx.com', 'phone': '8582470550'}], 'facility': 'Candid Clinical Site', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'contacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ClinicalTrials@candidrx.com', 'phone': '8582470550'}], 'facility': 'Candid Clinical Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ClinicalTrials@candidrx.com', 'phone': '8582470550'}], 'facility': 'Candid Clinical Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Kyiv', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ClinicalTrials@candidrx.com', 'phone': '8584270550'}], 'facility': 'Candid Clinical Site, Kyiv', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'centralContacts': [{'name': 'Clinical Operations', 'role': 'CONTACT', 'email': 'ClinicalTrials@candidrx.com', 'phone': '858-247-0550'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Candid Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}