Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT07147959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET-Based Imaging of Radiolabeled CIT-013
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of radiolabeled CIT-013 in patients with IMIDs', 'timeFrame': '24 hours', 'description': 'Whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of \\[89Zr\\]-DFO-CIT013 will be quantified per organ(-system). In vivo distribution profiles will be evaluated per cohort to determine ranges of uptake per organ(-system) and between cohorts to compare uptake in different IMIDs'}], 'secondaryOutcomes': [{'measure': 'safety and tolerability of CIT-013 in patients with IMIDs.', 'timeFrame': 'Day 29', 'description': 'Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RA']}, 'descriptionModule': {'briefSummary': "Inflammatory mediated immune diseases (IMIDs), such as rheumatoid arthritis (RA) and hidradenitis suppurativa (HS), are characterized by chronic inflammation resulting from an aberrant immune response. Recent studies have identified neutrophil extracellular traps (NETs) as key contributors to the pathology of these diseases. CIT-013 is a novel humanized monoclonal antibody designed to inhibit NET release and enhance phagocytosis, offering a new potential therapeutic strategy for RA and HS. Previous clinical trials have demonstrated that CIT-013 is well tolerated in both healthy volunteers and patients with RA, with evidence of reduced NET formation and positive effects in active RA cases. Since NET-related inflammation primarily occurs in local tissues, understanding CIT-013's distribution beyond blood measurements is crucial for evaluating its therapeutic potential. This trial therefore uses radiolabeled CIT-013 and Positron Emission Tomography-Computed Tomography (PET-CT) imaging, along with lymph node biopsies, to evaluate the distribution of CIT-013 and target engagement in patients with IMIDs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female (of non-childbearing potential) or male between 60-85 years of age (both inclusive).\n* For male participants with female partners of child-bearing potential, an adequate form of contraception must be adhered to, and men must refrain from donating sperm, prior to entry into the trial and for a further 6 months after IP administration.\n* Willing and able to provide written, informed consent.\n\nExclusion Criteria:\n\n* Diagnosed with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 6 months prior to screening (diagnosis based on medical records).\n\nParticipants in Cohort A (active RA) must furthermore meet the following criteria:\n\n\\- Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) (DAS28-CRP) ≥ 4.2 AND ≥ 1 Swollen Joint AND ≥ 1 Tender Joint prior to screening.'}, 'identificationModule': {'nctId': 'NCT07147959', 'acronym': 'Cityview', 'briefTitle': 'PET-Based Imaging of Radiolabeled CIT-013', 'organization': {'class': 'INDUSTRY', 'fullName': 'Citryll BV'}, 'officialTitle': 'PET-Based Imaging to Evaluate the Distribution of Radiolabeled CIT-013 in Patients With Inflammatory Mediated Immune Disease', 'orgStudyIdInfo': {'id': 'CITRYLL004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[89Zr]Zr-CIT-013', 'interventionNames': ['Drug: [89Zr]Zr-CIT']}], 'interventions': [{'name': '[89Zr]Zr-CIT', 'type': 'DRUG', 'description': 'radiolabelled CIT-013', 'armGroupLabels': ['[89Zr]Zr-CIT-013']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'contacts': [{'name': 'PI NL-01', 'role': 'CONTACT'}], 'facility': 'NL-01', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Leonie Middelink', 'role': 'CONTACT', 'email': 'lmiddelink@citryll.com', 'phone': '+31613328444'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Citryll BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}