Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT07280156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multiple IV infusions at a fixed dose per infusion, at different treatment intervals . For different dosing regimens, PRX-115 will be tested with and without the immunomodulator, MTX.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6', 'timeFrame': '6 months of treatment', 'description': 'Proportion of patients who achieve a reduction in sUA to \\<6.0 mg/dL for at least 80% of the time during Month 6'}], 'secondaryOutcomes': [{'measure': 'Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) at different time points', 'timeFrame': '3 to 6 months of treatment', 'description': 'Proportion of patients that achieve a reduction in sUA to \\<6.0 mg/dL for at least 80% of the time during Month 3 or 4, 5 and 6.'}, {'measure': 'Safety of PRX-115', 'timeFrame': 'From enrollment to 8 months of study', 'description': 'Occurrence and severity of treatment-emergent adverse events (TEAEs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gout', 'uricase', 'uric acid', 'hyperuricemia', 'PRX-115'], 'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.', 'detailedDescription': 'This study will evaluate the efficacy, safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PRX-115 (a recombinant pegylated Uricase) in adult patients with gout. Participants will receive PRX-115 by intravenous (IV) infusions according to different treatment schedules, with and without the immunomodulator methotrexate (MTX).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females ≥18 years of age.\n2. Weight within the range of 50.0 - 150.0 kg.\n3. Gout patients who failed to normalize sUA (\\<7 mg/dL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs.\n4. Willing to discontinue any oral ULT\n5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.\n\nExclusion Criteria:\n\n1. Any condition known to have arthritis as a clinical manifestation.\n2. Positive testing for HBV,HCV, or HIV.\n3. The patient is a pregnant or lactating female or plans to become pregnant during the study period.\n4. Known allergy or sensitivity to the injected proteins, including pegylated products.\n5. Prior exposure to any experimental or marketed uricase.\n6. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.\n7. History of anaphylaxis, severe allergic reactions, or severe atopy.\n8. G6PD deficiency or known catalase deficiency.\n9. History of significant hematologic or autoimmune disorders within 5 years of Screening and/or patient is immunocompromised or treated with immunosuppressive medications.\n10. Non-compensated CHF or hospitalization for CHF (Stage 3-4 NYHA Functional Class) within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled BP (\\>160/100 mmHg) at screening and prior to randomization at Week -4 (Visit 1).\n11. Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit.\n12. Chronic liver disease.\n13. Hemoglobin \\<11 g/dL, neutrophil count \\<1500 /µl, or platelet count \\<100,000 /µl.\n14. Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.\n15. eGFR ≤ 40 mL/min/1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.\n16. Known intolerance and/or known contraindication to MTX treatment or MTX treatment considered inappropriate\n17. Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded.\n18. Has known latent autoimmune diabetes of adult.\n19. Immunocompromised state, regardless of etiology.\n20. History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)'}, 'identificationModule': {'nctId': 'NCT07280156', 'acronym': 'RELEASE', 'briefTitle': 'A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protalix'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)', 'orgStudyIdInfo': {'id': 'PB115-GT-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E4W with placebo-MTX', 'description': 'IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX', 'interventionNames': ['Biological: PRX-115', 'Other: Placebo-Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'E4W with MTX', 'description': 'IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX', 'interventionNames': ['Biological: PRX-115', 'Drug: Methotrexate (MTX)']}, {'type': 'EXPERIMENTAL', 'label': 'E6W with MTX', 'description': 'IV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX', 'interventionNames': ['Biological: PRX-115', 'Drug: Methotrexate (MTX)']}, {'type': 'EXPERIMENTAL', 'label': 'E8W with MTX', 'description': 'IV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses + 3 doses of PRX-115 placebo every alternating 8 weeks with MTX', 'interventionNames': ['Biological: PRX-115', 'Drug: Methotrexate (MTX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo E4W', 'description': 'infusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX', 'interventionNames': ['Other: PRX-115 placebo', 'Other: Placebo-Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo E6W', 'description': 'IV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX', 'interventionNames': ['Other: PRX-115 placebo', 'Other: Placebo-Methotrexate']}], 'interventions': [{'name': 'PRX-115', 'type': 'BIOLOGICAL', 'description': 'intravenous (IV) infusion', 'armGroupLabels': ['E4W with MTX', 'E4W with placebo-MTX', 'E6W with MTX', 'E8W with MTX']}, {'name': 'Methotrexate (MTX)', 'type': 'DRUG', 'description': 'Oral MTX 15 mg weekly', 'armGroupLabels': ['E4W with MTX', 'E6W with MTX', 'E8W with MTX']}, {'name': 'PRX-115 placebo', 'type': 'OTHER', 'description': 'intravenous (IV) infusion', 'armGroupLabels': ['placebo E4W', 'placebo E6W']}, {'name': 'Placebo-Methotrexate', 'type': 'OTHER', 'description': 'Oral Placebo-MTX weekly', 'armGroupLabels': ['E4W with placebo-MTX', 'placebo E4W', 'placebo E6W']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Head of Clinical Development', 'role': 'CONTACT', 'email': 'info@protalix.com', 'phone': '+972-4-902-8100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protalix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}