A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Launched by AMGEN · Jan 19, 2024

Nctid: NCT06229145

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"abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>240}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-18", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-05-18", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-16", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Proportion of Participants achieving and maintaining serum uric acid (sUA) < 6 mg/dL at least 80% of the time", "timeFrame"=>"Month 6"}], "secondaryOutcomes"=>[{"measure"=>"Proportion of Participants with complete resolution of ≥ 1 tophus", "timeFrame"=>"Week 24"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Uncontrolled Gout", "pegloticase", "Krystexxa", "Methotrexate", "Chronic Gout"], "conditions"=>["Gout"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.amgentrials.com", "label"=>"AmgenTrials clinical trials website"}]}, "descriptionModule"=>{"briefSummary"=>"The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.\n\nThe main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \\< 6 mg/dL for at least 80% of the time.", "detailedDescription"=>"Acquired from Horizon in 2024."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Adult men or women ≥ 18 years of age\n2. Uncontrolled gout, defined as meeting the following criteria:\n\n * Hyperuricemia during the Screening Period, defined as sUA ≥ 7 mg/dL, and;\n * Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or participant interview, and;\n * Symptoms of gout\n3. Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions\n4. Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4.\n5. Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial.\n\nExclusion Criteria:\n\n1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis\n2. Current or chronic treatment with systemic immunosuppressive agents, such as MTX, azathioprine or mycophenolate mofetil; prednisone \\> 10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer)\n3. History of any transplant surgery requiring maintenance immunosuppressive therapy\n4. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity\n5. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative\n6. Known history of human immunodeficiency virus (HIV) positivity\n7. G6PD deficiency (quantitative test at the Screening Visit centrally or locally)\n8. Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina) or uncontrolled blood pressure (\\> 160/100 mmHg) prior to Week -4\n9. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner or not on an effective form of birth control, as determined by the Investigator\n10. Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug\n11. Unable to tolerate MTX 15 mg orally during the MTX Run-in Period\n12. Chronic liver disease\n13. White blood cell count \\< 4,000/μL, hematocrit \\< 32% or platelet count \\< 75,000/μL\n14. Currently receiving systemic or radiologic treatment for ongoing cancer\n15. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix\n16. Diagnosis of osteomyelitis\n17. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome\n18. A known intolerance to all protocol-standard gout flare prophylaxis regimens (i.e., participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day)\n19. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening."}, "identificationModule"=>{"nctId"=>"NCT06229145", "briefTitle"=>"A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Amgen"}, "officialTitle"=>"A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)", "orgStudyIdInfo"=>{"id"=>"HZNP-KRY-409"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Pegloticase + Methotrexate Q4W", "description"=>"16 mg pegloticase will be administered intravenously every 4 weeks for 24 weeks during double blind treatment and 24 weeks during open label.", "interventionNames"=>["Biological: Pegloticase", "Drug: Methotrexate"]}, {"type"=>"EXPERIMENTAL", "label"=>"Pegloticase + Methotrexate Q2W", "description"=>"8 mg pegloticase will be administered intravenously every 2 weeks for 24 weeks during double blind treatment and 16 mg pegloticase every 4 weeks for 24 weeks during open label.", "interventionNames"=>["Biological: Pegloticase", "Drug: Methotrexate"]}], "interventions"=>[{"name"=>"Pegloticase", "type"=>"BIOLOGICAL", "description"=>"IV infusion", "armGroupLabels"=>["Pegloticase + Methotrexate Q2W", "Pegloticase + Methotrexate Q4W"]}, {"name"=>"Methotrexate", "type"=>"DRUG", "description"=>"Oral", "armGroupLabels"=>["Pegloticase + Methotrexate Q2W", "Pegloticase + Methotrexate Q4W"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"The University of Alabama at Birmingham (UAB)", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"99508", "city"=>"Anchorage", "state"=>"Alaska", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Orthopedic Physicians Alaska - 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