Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-04-11 @ 12:05 PM
Study NCT ID:
NCT06522035
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome- assessment of change from baseline in Psoriasis Area and Severity Index (PASI).', 'timeFrame': '12 months'}, {'measure': 'Exploratory outcome- assessment of change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score.', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': '12 months', 'description': 'Number and severity of AEs, SAEs and injection reactions following treatment'}], 'secondaryOutcomes': [{'measure': 'Patient reported pain Numeric Rating Scale (NRS) in the target joint.', 'timeFrame': '3 months, 6 months and 12 months.', 'description': 'Evaluation of change from baseline in patient reported pain Numeric Rating Scale (NRS) in the target joint.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Psoriatic']}, 'descriptionModule': {'briefSummary': 'This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).', 'detailedDescription': 'Psoriatic Arthritis (PsA) is a prevalent chronic inflammatory disease that mainly affects the synovial joints, and leads to inflammatory arthritis, in addition to skin manifestations. If left untreated, inflammatory arthritis leads to joint damage and deformities.\n\nAllocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.\n\nAs macrophages play a crucial role in the initiation of PsA immunopathogenesis, they are considered an emerging target for PsA treatment.\n\nThis study will assess the safety of Allocetra injection to the joint (knee, elbow or ankle) in patients with PsA, and evaluate the preliminary responses to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with PsA.\n2. Stage 1 patients:\n\n At least one joint resistant to standard PsA treatments and on a stable dose of approved PsA treatment for at least 3 months prior to treatment.\n3. Stage 2 patients:\n\n At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.\n4. Acceptable blood tests- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function.\n\nExclusion Criteria:\n\n1. Prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment.\n2. Any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment.\n3. Findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint.\n4. Evidence of active local infection in the target joint.\n5. Concomitant rheumatic, inflammatory or autoimmune disease other than PsA.\n6. Other limb pain of unknown etiology.\n7. Any evidence of clinically significant active infection.\n8. Major medical condition as detailed in the protocol.'}, 'identificationModule': {'nctId': 'NCT06522035', 'briefTitle': 'Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enlivex Therapeutics Ltd.'}, 'officialTitle': 'Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'ENX-CL-06-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1', 'description': 'Stage 1 will include patients who have been treated with standard PsA therapies, and are insufficiently responsive to treatment in one or more involved joints.', 'interventionNames': ['Drug: Allocetra']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2', 'description': 'Stage 2 will include patients with oligoarticular PsA (1-4 joints involved), who have received at least one injection of corticosteroids to the target joint with insufficient response.', 'interventionNames': ['Drug: Allocetra']}], 'interventions': [{'name': 'Allocetra', 'type': 'DRUG', 'description': 'Intra-articular injecton of Allocetra into the target joint.', 'armGroupLabels': ['Stage 1', 'Stage 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yolanda Braun, Prof., MD', 'role': 'CONTACT', 'email': 'y_braun@rambam.health.gov.il', 'phone': '+972-502061905'}, {'name': 'Yolanda Braun, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3436212', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Devy Zisman, Prof., MD', 'role': 'CONTACT', 'email': 'devyzi@clalit.org.il', 'phone': '+972-506265526'}, {'name': 'Devy Zisman, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4428164', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shaye Kivity, Prof., MD', 'role': 'CONTACT', 'email': 'shaye.kivity@clalit.org.il', 'phone': '+972-52-666-8134'}, {'name': 'Shaye Kivity, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '6423906', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ori Elkayam, Prof., MD', 'role': 'CONTACT', 'email': 'orie@tlvmc.gov.il', 'phone': '+972-524266893'}, {'name': 'Ori Elkayam, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tel Aviv Sourasky Medical Center - Ichilov', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Naama Kama', 'role': 'CONTACT', 'email': 'naama@enlivexpharm.com', 'phone': '+972-52-3466908'}, {'name': 'Lital Weinfeld Bergman', 'role': 'CONTACT', 'email': 'lital@enlivexpharm.com', 'phone': '+972-52-5527554'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enlivex Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}