[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629670":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":174,"collaborators":43,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":43,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":43,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":142,"whyStopped":43,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":187},{"fullName":5,"class":6},"BioMarin Pharmaceutical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Palynziq naïve","EXPERIMENTAL","Individuals with uncontrolled blood phenylalanine (Phe) \\> 600 μmol\u002FL on existing management who have never been treated with Palynziq. Participants will have a 4-week Screening Period, followed by a 4-week MTX Tolerability Period during which only MTX will be administered. If MTX is tolerated during the MTX Tolerability Period, the participant will then enter the 24-week Combination Treatment Period during which MTX + Palynziq will be administered concurrently. After completion of Week 24 (Combination Treatment Period), MTX will be discontinued for both cohorts and Palynziq only will continue for another 24 weeks (to Week 49).",[13,14],"Biological: Pegvaliase","Drug: Methotrexate",{"label":16,"type":10,"description":17,"interventionNames":18},"Palynziq experienced","Individuals who have uncontrolled blood Phe \\> 600 μmol\u002FL after ≥ 24 consecutive weeks of treatment with Palynziq, are on a current dose of ≥ 20mg\u002Fday and are unable to further dose escalate (Palynziq experienced). Participants will have a 4-week Screening Period. Participants will then have 24 weeks of concurrent MTX + Palynziq treatment (Combination Treatment Period): participants will be assessed for MTX tolerability during the first 4 weeks of MTX + Palynziq (MTX Tolerability Period) and then receive another 20 weeks of MTX + Palynziq. After completion of Week 24 (Combination Treatment Period), MTX will be discontinued for both cohorts and Palynziq only will continue for another 24 weeks (to Week 49).",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Pegvaliase","Pegvaliase (Palynziq) administered by subcutaneous injection. Dosing follows U.S. Prescribing Information and investigator judgement.",[16,9],[26],"Palynziq",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Methotrexate","Oral methotrexate 15 mg administered once weekly during the Tolerability Period and the Combination Treatment Period.",[16,9],[33],"MTX",[35],{"name":36,"affiliation":5,"role":37},"Medical Director, MD","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Trial Specialist","CONTACT","1-800-983-4587",null,"medinfo@bmrn.com",[46,60,70,80,90,100,110,120,130,140,154,164],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":43},"UCLA Dept. of Human Genetics","NOT_YET_RECRUITING","Los Angeles","California","90095","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":43},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":55,"coordinates":66},[67,68],-104.83192,39.72943,{"lat":68,"lon":67},{"facility":71,"status":48,"city":72,"state":73,"zip":74,"country":52,"countryCode":53,"cosmosGeoPoint":75,"geoPoint":79,"contacts":43},"University Of South Florida Medical Center","Tampa","Florida","33613",{"type":55,"coordinates":76},[77,78],-82.45843,27.94752,{"lat":78,"lon":77},{"facility":81,"status":48,"city":82,"state":83,"zip":84,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":43},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":55,"coordinates":86},[87,88],-87.65005,41.85003,{"lat":88,"lon":87},{"facility":91,"status":48,"city":92,"state":93,"zip":94,"country":52,"countryCode":53,"cosmosGeoPoint":95,"geoPoint":99,"contacts":43},"Indiana University School of Medicine","Indianapolis","Indiana","46202",{"type":55,"coordinates":96},[97,98],-86.15804,39.76838,{"lat":98,"lon":97},{"facility":101,"status":48,"city":102,"state":103,"zip":104,"country":52,"countryCode":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":43},"University of Minnesota Medical School","Minneapolis","Minnesota","55455",{"type":55,"coordinates":106},[107,108],-93.26384,44.97997,{"lat":108,"lon":107},{"facility":111,"status":48,"city":112,"state":113,"zip":114,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":43},"University of Rochester Medical Center (URMC)","Rochester","New York","14642",{"type":55,"coordinates":116},[117,118],-77.61556,43.15478,{"lat":118,"lon":117},{"facility":121,"status":48,"city":122,"state":123,"zip":124,"country":52,"countryCode":53,"cosmosGeoPoint":125,"geoPoint":129,"contacts":43},"Oregon Health & Science University (OHSU) - PARENT","Portland","Oregon","97239",{"type":55,"coordinates":126},[127,128],-122.67621,45.52345,{"lat":128,"lon":127},{"facility":131,"status":48,"city":132,"state":133,"zip":134,"country":52,"countryCode":53,"cosmosGeoPoint":135,"geoPoint":139,"contacts":43},"University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh","Philadelphia","Pennsylvania","19104",{"type":55,"coordinates":136},[137,138],-75.16362,39.95238,{"lat":138,"lon":137},{"facility":141,"status":142,"city":143,"state":144,"zip":145,"country":52,"countryCode":53,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390",{"type":55,"coordinates":147},[148,149],-96.80667,32.78306,{"lat":149,"lon":148},[152],{"name":153,"role":41,"phone":43,"phoneExt":43,"email":43},"Markey McNutt",{"facility":155,"status":48,"city":156,"state":157,"zip":158,"country":52,"countryCode":53,"cosmosGeoPoint":159,"geoPoint":163,"contacts":43},"University of Utah Hospital","Salt Lake City","Utah","84108",{"type":55,"coordinates":160},[161,162],-111.89105,40.76078,{"lat":162,"lon":161},{"facility":165,"status":48,"city":166,"state":167,"zip":168,"country":52,"countryCode":53,"cosmosGeoPoint":169,"geoPoint":173,"contacts":43},"Children's Hospital of Wisconsin","Milwaukee","Wisconsin","53226",{"type":55,"coordinates":170},[171,172],-87.90647,43.0389,{"lat":172,"lon":171},{"type":175,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100629670","phase-4-immune-modulation-during-palynziq-treatment-in-adults-impala-100629670",false,"NCT07477691","Immune Modulation During Palynziq® Treatment in Adults (IMPALA)","A Phase 4 Study of Immune Modulation During Palynziq® Treatment in Adults With Phenylketonuria (PKU)","Inclusion Criteria:\n\n* Adults between 18 and 65 years old\n* Have a confirmed diagnosis of phenylketonuria (PKU)\n* Are in generally good health based on medical evaluation\n* Are willing and medically eligible to receive Palynziq and methotrexate (MTX) Cohort A: Have never taken Palynziq before and are willing to start it during the study Cohort B: Have blood \\> 600 μmol\u002FL after taking Palynziq for at least 24 weeks, are on a daily dose of at least 20mg and unable to increase the dose further\n* Agree to use required contraception if they or their partner could become pregnant\n* Are willing to carry two epinephrine devices at all times during Palynziq treatment\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, planning to become pregnant, planning to father a child, or not using effective birth control if applicable\n* Have a known severe allergy or hypersensitivity reaction to methotrexate (MTX), Palynziq, or other PEG-containing medications\n* Have a serious active infection or a history of severe or recurrent infections\n* Have significant medical conditions that may affect safety or participation (such as serious heart, lung, liver, kidney, immune, neurological, psychiatric, or cancer-related conditions)\n* Have a history of substance or alcohol abuse within the past 12 months\n* Have had an organ transplant or are taking chronic immunosuppressive medications\n* Are currently taking medications that are not allowed in the study, including other PKU treatments besides Palynziq\n* Are using, or plan to use, injectable PEG-containing medications other than Palynziq during the study\n* Have major surgery planned during the study participation period\n* Are currently participating in another clinical study involving Palynziq\n* In the opinion of the study doctor, are not a suitable candidate for the study or may have difficulty complying with study requirements","ALL","18 Years","65 Years",{"count":187,"type":188},12,"ESTIMATED","INTERVENTIONAL",[191],"PHASE4","Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.",[194],"Phenylketonuria",[196,194,22,26,29,197,198,199,200,201,202,203],"PKU","Immune Response","Safety","Immune Modulation","BMN 165-401","Hyperphenylalaninemia","Enzyme Substitution Therapy","Pharmacologic Immunosuppression","2026-06-16",{"date":206,"type":207},"2026-06-17","ACTUAL",{"date":209,"type":207},"2026-05-29",{"date":211,"type":188},"2027-09-30",{"name":5,"class":6}]