[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605956":3},{"organization":4,"armGroups":7,"interventions":63,"overallOfficials":69,"centralContacts":81,"locations":87,"responsibleParty":227,"collaborators":69,"id":229,"slug":69,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":69,"eligibilityCriteria":234,"healthyVolunteers":230,"sex":235,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":69,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":90,"whyStopped":69,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":280},{"fullName":5,"class":6},"QED Therapeutics, a BridgeBio company","INDUSTRY",[8,14,17,20,23,28,31,34,37,42,45,48,52,57,60],{"label":9,"type":10,"description":11,"interventionNames":12},"SAD Cohort 1 infigratinib (2 to less than 3 years old)","EXPERIMENTAL","Single Ascending Dose Escalation and PK Portion",[13],"Drug: Infigratinib is provided as a single dose of minitablets for oral administration",{"label":15,"type":10,"description":11,"interventionNames":16},"SAD Cohort 2 infigratinib (1 to less than 2 years old)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SAD Cohort 3 infigratinib (6 months to less than 1 year old)",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"SAD Cohort 4 infigratinib (0 to less than 6 months old)",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2 Cohort 1 infigratinib (2 to less than 3 years old)","Open-label Safety and PK Portion",[27],"Drug: Infigratinib is provided as sprinkle capsules for daily oral administration",{"label":29,"type":10,"description":25,"interventionNames":30},"Phase 2 Cohort 2 infigratinib (1 to less than 2 years old)",[27],{"label":32,"type":10,"description":25,"interventionNames":33},"Phase 2 Cohort 3 infigratinib (6 months to less than 1 year old)",[27],{"label":35,"type":10,"description":25,"interventionNames":36},"Phase 2 Cohort 4 infigratinib (0 to less than 6 months)",[27],{"label":38,"type":10,"description":39,"interventionNames":40},"Phase 2B Cohort 1 infigratinib (2 to less than 3 years old)","Randomized Safety and Efficacy Portion",[41],"Drug: Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration",{"label":43,"type":10,"description":39,"interventionNames":44},"Phase 2B Cohort 2 infigratinib (6 months to less than 2 years old)",[41],{"label":46,"type":10,"description":39,"interventionNames":47},"Phase 2B Cohort 3 infigratinib (0 to less than 6 months old)",[41],{"label":49,"type":10,"description":50,"interventionNames":51},"Open- label Extension infigratinib (0 months to 3 years [+6 months old])","Open-label extension portion continuing to assess safety and efficacy in children until they reach 3 years old (+6 months)",[27],{"label":53,"type":54,"description":55,"interventionNames":56},"Phase 2B Cohort 1 Placebo (2 to less than 3 years old)","PLACEBO_COMPARATOR","Randomized Safety and Efficacy study",[41],{"label":58,"type":54,"description":55,"interventionNames":59},"Phase 2B Cohort 2 placebo (6 months to less than 2 years old)",[41],{"label":61,"type":54,"description":55,"interventionNames":62},"Phase 2B Cohort 3 Placebo (0 to less than 6 months old)",[41],[64,70,74,78],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","Infigratinib is provided as a single dose of minitablets for oral administration","* The initial cohort dose of infigratinib will begin at the protocol-specified starting dose, with subsequent cohort escalation based on protocol specific criteria.\n* The target dose is the dose that will provide similar exposure to the dose of 0.25 mg\u002Fkg\u002Fday in participants 3 years old and older.\n* The dose and number of minitablets will be calculated based on individual participant age and weight.",[9,15,18,21],null,{"type":65,"name":71,"description":72,"armGroupLabels":73,"otherNames":69},"Infigratinib is provided as sprinkle capsules for daily oral administration","* The cohort dose of infigratinib will be the dose identified in the Single Ascending Dose portion for the age group.\n* The dose and number of sprinkle capsules\u002Fday will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months.",[24,29,32,35],{"type":65,"name":75,"description":76,"armGroupLabels":77,"otherNames":69},"Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration","* The cohort dose of infigratinib or placebo will be the dose confirmed in the Phase 2 portion for the age group.\n* The dose and number of sprinkle capsules\u002Fday will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months.",[53,38,43,58,61,46],{"type":65,"name":71,"description":79,"armGroupLabels":80,"otherNames":69},"* The dose of infigratinib will be the dose confirmed in the Phase 2 portion and used in the Phase 2b portion for the age group.\n* The dose and number of sprinkle capsules\u002Fday will be calculated based on individual participant age and weight. Doses will be adjusted based on age and weight changes approximately every 3 months for the first year and every 6 months thereafter.",[49],[82],{"name":83,"role":84,"phone":85,"phoneExt":69,"email":86},"QED Therapeutics Inc.","CONTACT","18772805655","medinfo@qedtx.com",[88,102,112,122,134,146,156,167,177,189,200,209,218],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":69},"UCSF Benioff Children's Hospital","RECRUITING","Oakland","California","94609","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-122.2708,37.80437,{"lat":100,"lon":99},{"facility":103,"status":90,"city":104,"state":105,"zip":106,"country":94,"countryCode":95,"cosmosGeoPoint":107,"geoPoint":111,"contacts":69},"Johns Hopkins University","Baltimore","Maryland","21218",{"type":97,"coordinates":108},[109,110],-76.61219,39.29038,{"lat":110,"lon":109},{"facility":113,"status":90,"city":114,"state":115,"zip":116,"country":94,"countryCode":95,"cosmosGeoPoint":117,"geoPoint":121,"contacts":69},"University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic","Madison","Wisconsin","53705",{"type":97,"coordinates":118},[119,120],-89.40123,43.07305,{"lat":120,"lon":119},{"facility":123,"status":90,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":69},"Murdoch Children's Research Institute","Parkville","Victoria","3052","Australia","AU",{"type":97,"coordinates":130},[131,132],144.95,-37.78333,{"lat":132,"lon":131},{"facility":135,"status":90,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":69},"Children's Hospital of Eastern Ontario Research Institute","Ottawa","Ontario","K1H 8L1","Canada","CA",{"type":97,"coordinates":142},[143,144],-75.69812,45.41117,{"lat":144,"lon":143},{"facility":147,"status":90,"city":148,"state":149,"zip":150,"country":139,"countryCode":140,"cosmosGeoPoint":151,"geoPoint":155,"contacts":69},"Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":97,"coordinates":152},[153,154],-73.58781,45.50884,{"lat":154,"lon":153},{"facility":157,"status":90,"city":158,"state":69,"zip":159,"country":160,"countryCode":161,"cosmosGeoPoint":162,"geoPoint":166,"contacts":69},"Paediatric Clinical Research Unit at Oslo University Hospital","Oslo","0372","Norway","NO",{"type":97,"coordinates":163},[164,165],10.74609,59.91273,{"lat":165,"lon":164},{"facility":168,"status":90,"city":169,"state":69,"zip":170,"country":169,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":69},"KK Women's and Children's Hospital","Singapore","2298899","SG",{"type":97,"coordinates":173},[174,175],103.85007,1.28967,{"lat":175,"lon":174},{"facility":178,"status":179,"city":180,"state":69,"zip":181,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":69},"Unidad de Cirugia Artroscopica (UCA)","NOT_YET_RECRUITING","Vitoria-Gasteiz","01010","Spain","ES",{"type":97,"coordinates":185},[186,187],-2.67268,42.84998,{"lat":187,"lon":186},{"facility":190,"status":90,"city":191,"state":69,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":69},"NHS Greater Glasgow and Clyde","Glasgow","G3 8SJ","United Kingdom","UK",{"type":97,"coordinates":196},[197,198],-4.25763,55.86515,{"lat":198,"lon":197},{"facility":201,"status":179,"city":202,"state":69,"zip":203,"country":193,"countryCode":194,"cosmosGeoPoint":204,"geoPoint":208,"contacts":69},"Guy's and Saint Thomas' NHS Foundation Trust","London","SE1 7EH",{"type":97,"coordinates":205},[206,207],-0.12574,51.50853,{"lat":207,"lon":206},{"facility":210,"status":179,"city":211,"state":69,"zip":212,"country":193,"countryCode":194,"cosmosGeoPoint":213,"geoPoint":217,"contacts":69},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":97,"coordinates":214},[215,216],-2.23743,53.48095,{"lat":216,"lon":215},{"facility":219,"status":90,"city":220,"state":69,"zip":221,"country":193,"countryCode":194,"cosmosGeoPoint":222,"geoPoint":226,"contacts":69},"Sheffield Children's NHS Foundation Trust","Sheffield","S10 2TH",{"type":97,"coordinates":223},[224,225],-1.4659,53.38297,{"lat":225,"lon":224},{"type":228,"investigatorFullName":69,"investigatorTitle":69,"investigatorAffiliation":69,"oldNameTitle":69,"oldOrganization":69},"SPONSOR","100605956",false,"NCT07169279","Interventional Study of Infigratinib in Children \u003C 3 Years Old With Achondroplasia (ACH)","Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Preceded by a Single Ascending Dose Portion and a Phase 2 Open-Label Portion, to Evaluate the Safety and Efficacy of Oral Infigratinib in Infants and Young Children With Achondroplasia","Inclusion Criteria:\n\n* Diagnosis of ACH confirmed by genetic testing. If prospective participants had prior genetic testing, the diagnosis must be confirmed by a report from a certified laboratory, documenting the specific mutation.\n* Age 0 to 32 months (2 years and 8 months) at screening.\n* Signed informed consent, which must be obtained from each participant's parent(s) or legal guardian.\n* Parent(s)\u002FGuardian(s) willing and able to attend all study visits and comply with all study requirements.\n* Parent(s)\u002FGuardian(s) willing and able to comply with the routine care of the study participants according to local guidance for the management of infants and young children with ACH.\n* Able to swallow age-appropriate oral medication.\n* In participants \\\u003C1 year old, be compliant with recommended vitamin D supplementation of 5 10 μg\u002Fday or higher (or as recommended by country specific guidelines).\n\nExclusion Criteria:\n\n* Participants who have hypochondroplasia or diagnosis of genetic condition other than ACH, or any clinical condition that can affect growth.\n* Gestational age at birth \\\u003C37 weeks and\u002For birth weight \\\u003C2500 grams.\n* Gastroesophageal reflux disease requiring prolonged treatment (\\>1 week) with prohibited medications.\n* Evidence of cervicomedullary compression, as defined by an Achondroplasia Foramen Magnum Score (AFMS) 4, symptomatic or asymptomatic, diagnosed during MRI done at screening or a previous MRI done at any time if the participant had not undergone decompression surgery.\n* History of fracture of a long bone or spine within 6 months prior to screening.\n* Any other significant concurrent disease or condition that, in the view of the investigator and\u002For sponsor, would confound assessment of efficacy or safety of infigratinib and\u002For would require treatment with a prohibited medication (per protocol), and\u002For would place the participant at high risk for poor treatment compliance or for failure to complete the study.\n* Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH or short stature, including (but not limited to) r-hGH, IGF-1, CNP analog, FGF ligand trap, or treatment targeting FGFR inhibition at any time.\n* Regular long-term (\\>3 weeks; more than twice\u002Fyear) treatment with supraphysiologic doses of glucocorticoid therapy (ie, \\>15 mg\u002Fm2\u002Fday of hydrocortisone or equivalent) or treatment with glucocorticoids at anti-inflammatory doses (for over 3 weeks within 6 months of the screening visit. NOTE: Low-dose topical, inhaled, or intranasal corticosteroids are acceptable.\n* Significant abnormality in screening laboratory results,\n* Allergy or hypersensitivity to any components of the study drug.","ALL","0 Years","32 Months",{"count":239,"type":240},77,"ESTIMATED","INTERVENTIONAL",[243],"PHASE2","This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \\\u003C 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \\\u003C 3 years old with ACH at the selected dose.",[246],"Achondroplasia",[248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270],"skeletal dysplasia","endochondral ossification","achondroplasia","ACH","Shortened proximal limbs","fibroblast growth factor receptor 3","FGFR3","encodhondral bone formation","disproportionate short stature","quality of life","dwarfism","bone diseases","musculoskeletal diseases","osteochondrodysplasia","functional abilities","annualized growth velocity","annualized height velocity","growth","growth disorder","congenital","AHV","AGV","infant and toddler","2026-06-16",{"date":273,"type":274},"2026-06-17","ACTUAL",{"date":276,"type":274},"2025-11-19",{"date":278,"type":240},"2032-03",{"name":5,"class":6},13]