[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07280156":3,"trial-entities:NCT07280156":264,"trial-summary:NCT07280156":267},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":57,"secondary_outcomes":62,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":79,"locations":82,"central_contacts":255,"overall_officials":261,"references":262,"see_also_links":263},"NCT07280156","PB115-GT-201","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)","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)","RECRUITING","2028-06","2026-05","2026-06-11","2025-12-22","Protalix","INDUSTRY",true,"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.","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).",[19],"Gout",[21,22,23,24,25],"gout","uricase","uric acid","hyperuricemia","PRX-115","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},150,"ESTIMATED",[34,42,47,53],{"type":35,"name":25,"description":36,"armGroupLabels":37},"BIOLOGICAL","intravenous (IV) infusion",[38,39,40,41],"E4W with MTX","E4W with placebo-MTX","E6W with MTX","E8W with MTX",{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","Methotrexate (MTX)","Oral MTX 15 mg weekly",[38,40,41],{"type":48,"name":49,"description":36,"armGroupLabels":50},"OTHER","PRX-115 placebo",[51,52],"placebo E4W","placebo E6W",{"type":48,"name":54,"description":55,"armGroupLabels":56},"Placebo-Methotrexate","Oral Placebo-MTX weekly",[39,51,52],[58],{"measure":59,"description":60,"timeFrame":61},"Percentage of Serum Uric Acid (sUA) Responders (sUA \u003C 6 mg\u002FdL) During Month 6","Proportion of patients who achieve a reduction in sUA to \\\u003C6.0 mg\u002FdL for at least 80% of the time during Month 6","6 months of treatment",[63,67],{"measure":64,"description":65,"timeFrame":66},"Percentage of Serum Uric Acid (sUA) Responders (sUA \u003C 6 mg\u002FdL) at different time points","Proportion of patients that achieve a reduction in sUA to \\\u003C6.0 mg\u002FdL for at least 80% of the time during Month 3 or 4, 5 and 6.","3 to 6 months of treatment",{"measure":68,"description":69,"timeFrame":70},"Treatment-emergent adverse events (TEAEs)","Occurrence and severity of treatment-emergent adverse events (TEAEs)","From enrollment to 8 months of study","ALL","18 Years",null,false,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"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 (\\\u003C7 mg\u002FdL) 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\u002For 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\u002F100 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 \\\u003C11 g\u002FdL, neutrophil count \\\u003C1500 \u002Fµl, or platelet count \\\u003C100,000 \u002Fµl.\n14. Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.\n15. eGFR ≤ 40 mL\u002Fmin\u002F1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.\n16. Known intolerance and\u002For 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)",[80,81],"ADULT","OLDER_ADULT",[83,92,100,108,115,122,129,136,140,144,151,155,162,168,176,184,192,200,207,214,218,222,225,229,233,241,248],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Applied Research Center of Arkansas","Little Rock","Arkansas","72205","United States",{"lat":90,"lon":91},34.74648,-92.28959,{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"Triwest Research Associates Llc","El Cajon","California","91910",{"lat":98,"lon":99},32.79477,-116.96253,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":88,"geoPoint":105},"Clinical Research of West Florida, Inc.","Clearwater","Florida","33765",{"lat":106,"lon":107},27.96585,-82.8001,{"facility":109,"status":8,"city":110,"state":103,"zip":111,"country":88,"geoPoint":112},"Accel Research Sites - Deland Clinical Research Unit","DeLand","32720",{"lat":113,"lon":114},29.02832,-81.30312,{"facility":116,"status":8,"city":117,"state":103,"zip":118,"country":88,"geoPoint":119},"ICR Sites East","Doral","33125",{"lat":120,"lon":121},25.81954,-80.35533,{"facility":123,"status":8,"city":124,"state":103,"zip":125,"country":88,"geoPoint":126},"Qway Research","Hialeah","33010",{"lat":127,"lon":128},25.8576,-80.27811,{"facility":130,"status":8,"city":131,"state":103,"zip":132,"country":88,"geoPoint":133},"Bioclinical Research Alliance, Inc","Miami","33155",{"lat":134,"lon":135},25.77427,-80.19366,{"facility":137,"status":8,"city":131,"state":103,"zip":138,"country":88,"geoPoint":139},"D&H National Research Centers (North Miami)","33169",{"lat":134,"lon":135},{"facility":141,"status":8,"city":131,"state":103,"zip":142,"country":88,"geoPoint":143},"Well Pharma Medical Research Group","33173",{"lat":134,"lon":135},{"facility":145,"status":8,"city":146,"state":103,"zip":147,"country":88,"geoPoint":148},"Conquest Research - Lake Nona","Orlando","32832",{"lat":149,"lon":150},28.53834,-81.37924,{"facility":152,"status":8,"city":146,"state":103,"zip":153,"country":88,"geoPoint":154},"Combined Research Orlando Phase I-IV","32897",{"lat":149,"lon":150},{"facility":156,"status":8,"city":157,"state":103,"zip":158,"country":88,"geoPoint":159},"New Horizons Research","Palmetto Bay","33176",{"lat":160,"lon":161},25.62177,-80.32477,{"facility":101,"status":8,"city":163,"state":103,"zip":164,"country":88,"geoPoint":165},"Tampa","33606",{"lat":166,"lon":167},27.94752,-82.45843,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":88,"geoPoint":173},"Centricity Research - Columbus Georgia Multispecialty","Columbus","Georgia","31904",{"lat":174,"lon":175},32.46098,-84.98771,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":88,"geoPoint":181},"Quest Research Institute","Farmington Hills","Michigan","48334",{"lat":182,"lon":183},42.48531,-83.37716,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":88,"geoPoint":189},"Altoona Center for Clinical Research","Duncansville","Pennsylvania","16635",{"lat":190,"lon":191},40.42341,-78.4339,{"facility":193,"status":8,"city":194,"state":195,"zip":196,"country":88,"geoPoint":197},"Pioneer Research Solutions Inc","Houston","Texas","77099",{"lat":198,"lon":199},29.76328,-95.36327,{"facility":201,"status":8,"city":202,"state":195,"zip":203,"country":88,"geoPoint":204},"Mt. Olympus Medical Research, LLC - Sugar Land","Sugar Land","77479",{"lat":205,"lon":206},29.61968,-95.63495,{"facility":208,"status":8,"city":209,"zip":210,"country":171,"geoPoint":211},"Aleksandre Aladashvili Clinic LLC, Georgia","Tbilisi","0102",{"lat":212,"lon":213},41.69143,44.83412,{"facility":215,"status":8,"city":209,"zip":216,"country":171,"geoPoint":217},"Tbilisi Heart and Vascular Clinic Ltd , Georgia","0159",{"lat":212,"lon":213},{"facility":219,"status":8,"city":209,"zip":220,"country":171,"geoPoint":221},"Mediclub Georgia","0160",{"lat":212,"lon":213},{"facility":223,"status":8,"city":209,"zip":220,"country":171,"geoPoint":224},"Tbilisi Institute of Medicine, Georgia",{"lat":212,"lon":213},{"facility":226,"status":8,"city":209,"zip":227,"country":171,"geoPoint":228},"Georgian-Dutch Hospital, Georgia","0172",{"lat":212,"lon":213},{"facility":230,"status":8,"city":209,"zip":231,"country":171,"geoPoint":232},"LTD First Medical Center, Georgia","0180",{"lat":212,"lon":213},{"facility":234,"status":8,"city":235,"zip":236,"country":237,"geoPoint":238},"HaEmek MC, Israel","Afula","1834111","Israel",{"lat":239,"lon":240},32.60907,35.2892,{"facility":242,"status":8,"city":243,"zip":244,"country":237,"geoPoint":245},"Barzilai MC, Israel","Ashkelon","7830604",{"lat":246,"lon":247},31.66926,34.57149,{"facility":249,"status":8,"city":250,"zip":251,"country":237,"geoPoint":252},"Meir MC, Israel","Kfar Saba","4438164",{"lat":253,"lon":254},32.175,34.90694,[256],{"name":257,"role":258,"phone":259,"email":260},"Head of Clinical Development","CONTACT","+972-4-902-8100","info@protalix.com",[],[],[],{"nct_id":4,"conditions":265,"biomarkers":266},[19],[],{"nct_id":4,"found":15,"summary":268,"prompt_version":278},{"design":269,"status":270,"heading":271,"summary":272,"follow_up":273,"word_count":274,"commitments":275,"compensation":276,"drugs_mentioned":277},"This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to different treatment groups, and neither you nor your doctors will know which treatment you are receiving. It is a Phase II study, and plans to enroll about 150 participants.","completed","Study of PRX-115 for Gout Treatment (RELEASE)","This study is testing PRX-115, a new intravenous (IV) infusion, to see how well it works and if it's safe for adults with gout. You might also receive methotrexate (MTX), a common medication, or a placebo (inactive substance). The study aims to enroll about 150 participants who are at least 18 years old, weigh between 50 and 150 kg, and whose gout hasn't been controlled by other treatments or who can't take those treatments. The main goal is to see what percentage of participants have their serum uric acid (sUA) levels drop below 6 mg\u002FdL after 6 months of treatment. The current recruitment status is unclear.","The primary endpoint is measured at 6 months of treatment, focusing on serum uric acid levels.",106,"Participants will receive PRX-115 or a placebo through intravenous (IV) infusions over 24 weeks, according to different schedules. You may also take oral methotrexate or a placebo weekly.","Not stated in the trial record.",[25,44],"v2"]