[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605956":3},{"organization":4,"outcomesModule":7,"designInfo":101,"detailedDescription":111,"studyPopulation":11,"armGroups":112,"interventions":168,"overallOfficials":11,"centralContacts":185,"locations":191,"responsibleParty":331,"collaborators":11,"id":333,"slug":11,"hasResults":334,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":11,"eligibilityCriteria":338,"healthyVolunteers":334,"sex":339,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":11,"studyType":345,"phases":346,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":194,"whyStopped":11,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},{"fullName":5,"class":6},"QED Therapeutics, a BridgeBio company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":11},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"Single Ascending Dose Portion: Identify the dose of infigratinib to be used in each age cohort of the Phase 2 potion of the study (by assessing safety and PK of infigratinib and its active metabolites)",null,"2 weeks",{"measure":14,"description":11,"timeFrame":15},"Phase 2 Portion: Confirm the doses to be used in each age cohort in the Phase 2b portion of the study (by assessing safety and PK of infigratinib and its active metabolites).","52 weeks",{"measure":17,"description":11,"timeFrame":15},"Phase 2b Portion: Evaluate the safety and efficacy of infigratinib in infants and children \u003C 3 years old with ACH (by assessing AE's & SAE's)",{"measure":19,"description":11,"timeFrame":20},"Extension Portion: Evaluate the safety and efficacy of infigratinib in participants who completed the Phase 2 or Phase 2b portion of the study until they have reached 3 years old (+6 months) (by assessing AE's and SAE's)","3 years and 6 months",[22,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52,54,56,58,60,62,64,66,68,70,72,74,76,79,81,83,85,87,89,91,93,95,97,99],{"measure":23,"description":11,"timeFrame":15},"Phase 2: Evaluate the safety of oral daily doses of infigratinib (by assessing AEs and SAEs)",{"measure":25,"description":11,"timeFrame":15},"Phase 2: Evaluate changes in indicators of growth (by assessing change from BL in body length z-score at Week 52 in relation to ACH tables)",{"measure":27,"description":11,"timeFrame":15},"Phase 2: Evaluate changes in indicators of body proportions (by assessing change from BL to Week 52 in upper-to-lower body segment ratio and head circumference\u002Fbody length ratio)",{"measure":29,"description":11,"timeFrame":15},"Phase 2: Change from BL in Health-related Quality of Life (HRQoL) (as assessed by Infant and Toddler Quality of Life Inventory [ITQoL] tool)",{"measure":31,"description":11,"timeFrame":15},"Phase 2: Milestone Development of motor skills (assessed with development milestone charts)",{"measure":33,"description":11,"timeFrame":15},"Phase 2: Milestone Development of language skills (assessed with development milestone charts)",{"measure":35,"description":11,"timeFrame":15},"Phase 2: Milestone Development of personal-social skills (assessed with development milestone charts)",{"measure":37,"description":11,"timeFrame":15},"Phase 2: Skull and brain morphology (as assessed using MRI)",{"measure":39,"description":11,"timeFrame":15},"Phase 2: Age at closure of cranial structures (as assessed by physical examination)",{"measure":41,"description":11,"timeFrame":15},"Phase 2: Age at closure of fontanelles (as assessed by physical examination)",{"measure":43,"description":11,"timeFrame":15},"Phase 2: Incidence of surgical interventions (i.e., cervical decompression, adenotonsillectomy etc)",{"measure":45,"description":11,"timeFrame":15},"Phase 2: Incidence and severity of sleep apnea (as assessed by polysomnography)",{"measure":47,"description":11,"timeFrame":15},"Phase 2: Bone morphology (as assessed using x-rays)",{"measure":49,"description":11,"timeFrame":15},"Phase 2b: Evaluate the pharmacokinetic (PK) profile of infigratinib and its metabolites (by assessing the PK of infigratinib and its active metabolites)",{"measure":51,"description":11,"timeFrame":15},"Phase 2b: Change from BL in Health-related Quality of Life (HRQoL) (as assessed by Infant and Toddler Quality of Life Inventory [ITQoL] tool)",{"measure":53,"description":11,"timeFrame":15},"Phase 2b: Evaluate the safety of oral daily doses of infigratinib (by assessing AEs and SAEs)",{"measure":55,"description":11,"timeFrame":15},"Phase 2b: Evaluate changes in indicators of growth (by assessing change from BL in body length z-score at Week 52 in relation to ACH tables)",{"measure":57,"description":11,"timeFrame":15},"Phase 2b: Evaluate changes in indicators of body proportions (by assessing change from BL to Week 52 in upper-to-lower body segment ratio and head circumference\u002Fbody length ratio)",{"measure":59,"description":11,"timeFrame":15},"Phase 2b: Milestone Development of motor skills (assessed with development milestone charts)",{"measure":61,"description":11,"timeFrame":15},"Phase 2b: Milestone development of language skills (assessed with development milestone charts)",{"measure":63,"description":11,"timeFrame":15},"Phase 2b: Milestone development of personal-social skills (assessed with development milestone charts)",{"measure":65,"description":11,"timeFrame":15},"Phase 2b: Skull and brain morphology (as assessed using MRI)",{"measure":67,"description":11,"timeFrame":15},"Phase 2b: Age at closure of cranial structures (as assessed by physical examination)",{"measure":69,"description":11,"timeFrame":15},"Phase 2b: Age at closure of fontanelles (as assessed by physical examination)",{"measure":71,"description":11,"timeFrame":15},"Phase 2b: Incidence of surgical interventions (i.e., cervical decompression, adenotonsillectomy etc)",{"measure":73,"description":11,"timeFrame":15},"Phase 2b: Incidence and severity of sleep apnea (as assessed by polysomnography)",{"measure":75,"description":11,"timeFrame":15},"Phase 2b: Bone morphology (as assessed using x-rays)",{"measure":77,"description":11,"timeFrame":78},"Extension Phase: Evaluate the safety of oral daily doses of infigratinib (by assessing AEs and SAEs)","Until they have reached 3 years old (+6 months)",{"measure":80,"description":11,"timeFrame":78},"Extension Phase: Change from BL in body length Z-score",{"measure":82,"description":11,"timeFrame":78},"Extension Phase: Change from BL in upper to lower body segment ratio (cm)",{"measure":84,"description":11,"timeFrame":78},"Extension Phase: Change from BL in head circumference body length ratio",{"measure":86,"description":11,"timeFrame":78},"Extension Phase: Milestone development of social\u002Femotional skills (assessed with development milestone charts)",{"measure":88,"description":11,"timeFrame":78},"Extension Phase: Milestone development of language communication skills (assessed with development milestone charts)",{"measure":90,"description":11,"timeFrame":78},"Extension Phase: Milestone development of cognitive skills (assessed with development milestone charts)",{"measure":92,"description":11,"timeFrame":78},"Extension Phase: Milestone development of movement\u002Fphysical development skills (assessed with development milestone charts)",{"measure":94,"description":11,"timeFrame":78},"Extension Phase: Age at closure of cranial structures (as assessed by physical examination)",{"measure":96,"description":11,"timeFrame":78},"Extension Phase: Age at closure of fontanelles (as assessed by physical examination)",{"measure":98,"description":11,"timeFrame":78},"Extension Phase: Incidence of surgical interventions (i.e., cervical decompression, adenotonsillectomy etc)",{"measure":100,"description":11,"timeFrame":78},"Extension Phase: Bone morphology (as assessed using x-rays)",{"allocation":102,"interventionModel":103,"interventionModelDescription":104,"primaryPurpose":105,"observationalModel":11,"timePerspective":11,"maskingInfo":106},"RANDOMIZED","PARALLEL","This study comprises 4 portions: a Single Ascending Dose (SAD) portion and open-label Phase 2 portion to evaluate safety and PK and select a dose level for Phase 2b; a placebo-controlled Phase 2b portion, to assess safety and efficacy at the selected dose level; and an open-label extension portion to evaluate safety and efficacy in children \\\u003C 3 years old who have completed the Phase 2 or Phase 2b portion of the study.","TREATMENT",{"masking":107,"maskingDescription":11,"whoMasked":108},"DOUBLE",[109,110],"PARTICIPANT","INVESTIGATOR","PROPEL Infant \\& Toddler (I\\&T) is a Phase 2, multicenter, randomized, placebo-controlled study that comprises 4 portions: the single ascending dose (SAD) portion (open-label), the Phase 2 portion (open-label), the Phase 2b portion (placebo-controlled), and an Extension Portion (open-label). The study will evaluate children with ACH \\\u003C 3 years old being administered oral infigratinib.",[113,119,122,125,128,133,136,139,142,147,150,153,157,162,165],{"label":114,"type":115,"description":116,"interventionNames":117},"SAD Cohort 1 infigratinib (2 to less than 3 years old)","EXPERIMENTAL","Single Ascending Dose Escalation and PK Portion",[118],"Drug: Infigratinib is provided as a single dose of minitablets for oral administration",{"label":120,"type":115,"description":116,"interventionNames":121},"SAD Cohort 2 infigratinib (1 to less than 2 years old)",[118],{"label":123,"type":115,"description":116,"interventionNames":124},"SAD Cohort 3 infigratinib (6 months to less than 1 year old)",[118],{"label":126,"type":115,"description":116,"interventionNames":127},"SAD Cohort 4 infigratinib (0 to less than 6 months old)",[118],{"label":129,"type":115,"description":130,"interventionNames":131},"Phase 2 Cohort 1 infigratinib (2 to less than 3 years old)","Open-label Safety and PK Portion",[132],"Drug: Infigratinib is provided as sprinkle capsules for daily oral administration",{"label":134,"type":115,"description":130,"interventionNames":135},"Phase 2 Cohort 2 infigratinib (1 to less than 2 years old)",[132],{"label":137,"type":115,"description":130,"interventionNames":138},"Phase 2 Cohort 3 infigratinib (6 months to less than 1 year old)",[132],{"label":140,"type":115,"description":130,"interventionNames":141},"Phase 2 Cohort 4 infigratinib (0 to less than 6 months)",[132],{"label":143,"type":115,"description":144,"interventionNames":145},"Phase 2B Cohort 1 infigratinib (2 to less than 3 years old)","Randomized Safety and Efficacy Portion",[146],"Drug: Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration",{"label":148,"type":115,"description":144,"interventionNames":149},"Phase 2B Cohort 2 infigratinib (6 months to less than 2 years old)",[146],{"label":151,"type":115,"description":144,"interventionNames":152},"Phase 2B Cohort 3 infigratinib (0 to less than 6 months old)",[146],{"label":154,"type":115,"description":155,"interventionNames":156},"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)",[132],{"label":158,"type":159,"description":160,"interventionNames":161},"Phase 2B Cohort 1 Placebo (2 to less than 3 years old)","PLACEBO_COMPARATOR","Randomized Safety and Efficacy study",[146],{"label":163,"type":159,"description":160,"interventionNames":164},"Phase 2B Cohort 2 placebo (6 months to less than 2 years old)",[146],{"label":166,"type":159,"description":160,"interventionNames":167},"Phase 2B Cohort 3 Placebo (0 to less than 6 months old)",[146],[169,174,178,182],{"type":170,"name":171,"description":172,"armGroupLabels":173,"otherNames":11},"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.",[114,120,123,126],{"type":170,"name":175,"description":176,"armGroupLabels":177,"otherNames":11},"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.",[129,134,137,140],{"type":170,"name":179,"description":180,"armGroupLabels":181,"otherNames":11},"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.",[158,143,148,163,166,151],{"type":170,"name":175,"description":183,"armGroupLabels":184,"otherNames":11},"* 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.",[154],[186],{"name":187,"role":188,"phone":189,"phoneExt":11,"email":190},"QED Therapeutics Inc.","CONTACT","18772805655","medinfo@qedtx.com",[192,206,216,226,238,250,260,271,281,293,304,313,322],{"facility":193,"status":194,"city":195,"state":196,"zip":197,"country":198,"countryCode":199,"cosmosGeoPoint":200,"geoPoint":205,"contacts":11},"UCSF Benioff Children's Hospital","RECRUITING","Oakland","California","94609","United States","US",{"type":201,"coordinates":202},"Point",[203,204],-122.2708,37.80437,{"lat":204,"lon":203},{"facility":207,"status":194,"city":208,"state":209,"zip":210,"country":198,"countryCode":199,"cosmosGeoPoint":211,"geoPoint":215,"contacts":11},"Johns Hopkins University","Baltimore","Maryland","21218",{"type":201,"coordinates":212},[213,214],-76.61219,39.29038,{"lat":214,"lon":213},{"facility":217,"status":194,"city":218,"state":219,"zip":220,"country":198,"countryCode":199,"cosmosGeoPoint":221,"geoPoint":225,"contacts":11},"University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic","Madison","Wisconsin","53705",{"type":201,"coordinates":222},[223,224],-89.40123,43.07305,{"lat":224,"lon":223},{"facility":227,"status":194,"city":228,"state":229,"zip":230,"country":231,"countryCode":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":11},"Murdoch Children's Research Institute","Parkville","Victoria","3052","Australia","AU",{"type":201,"coordinates":234},[235,236],144.95,-37.78333,{"lat":236,"lon":235},{"facility":239,"status":194,"city":240,"state":241,"zip":242,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":11},"Children's Hospital of Eastern Ontario Research Institute","Ottawa","Ontario","K1H 8L1","Canada","CA",{"type":201,"coordinates":246},[247,248],-75.69812,45.41117,{"lat":248,"lon":247},{"facility":251,"status":194,"city":252,"state":253,"zip":254,"country":243,"countryCode":244,"cosmosGeoPoint":255,"geoPoint":259,"contacts":11},"Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":201,"coordinates":256},[257,258],-73.58781,45.50884,{"lat":258,"lon":257},{"facility":261,"status":194,"city":262,"state":11,"zip":263,"country":264,"countryCode":265,"cosmosGeoPoint":266,"geoPoint":270,"contacts":11},"Paediatric Clinical Research Unit at Oslo University Hospital","Oslo","0372","Norway","NO",{"type":201,"coordinates":267},[268,269],10.74609,59.91273,{"lat":269,"lon":268},{"facility":272,"status":194,"city":273,"state":11,"zip":274,"country":273,"countryCode":275,"cosmosGeoPoint":276,"geoPoint":280,"contacts":11},"KK Women's and Children's Hospital","Singapore","2298899","SG",{"type":201,"coordinates":277},[278,279],103.85007,1.28967,{"lat":279,"lon":278},{"facility":282,"status":283,"city":284,"state":11,"zip":285,"country":286,"countryCode":287,"cosmosGeoPoint":288,"geoPoint":292,"contacts":11},"Unidad de Cirugia Artroscopica (UCA)","NOT_YET_RECRUITING","Vitoria-Gasteiz","01010","Spain","ES",{"type":201,"coordinates":289},[290,291],-2.67268,42.84998,{"lat":291,"lon":290},{"facility":294,"status":194,"city":295,"state":11,"zip":296,"country":297,"countryCode":298,"cosmosGeoPoint":299,"geoPoint":303,"contacts":11},"NHS Greater Glasgow and Clyde","Glasgow","G3 8SJ","United Kingdom","UK",{"type":201,"coordinates":300},[301,302],-4.25763,55.86515,{"lat":302,"lon":301},{"facility":305,"status":283,"city":306,"state":11,"zip":307,"country":297,"countryCode":298,"cosmosGeoPoint":308,"geoPoint":312,"contacts":11},"Guy's and Saint Thomas' NHS Foundation Trust","London","SE1 7EH",{"type":201,"coordinates":309},[310,311],-0.12574,51.50853,{"lat":311,"lon":310},{"facility":314,"status":283,"city":315,"state":11,"zip":316,"country":297,"countryCode":298,"cosmosGeoPoint":317,"geoPoint":321,"contacts":11},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":201,"coordinates":318},[319,320],-2.23743,53.48095,{"lat":320,"lon":319},{"facility":323,"status":194,"city":324,"state":11,"zip":325,"country":297,"countryCode":298,"cosmosGeoPoint":326,"geoPoint":330,"contacts":11},"Sheffield Children's NHS Foundation Trust","Sheffield","S10 2TH",{"type":201,"coordinates":327},[328,329],-1.4659,53.38297,{"lat":329,"lon":328},{"type":332,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":343,"type":344},77,"ESTIMATED","INTERVENTIONAL",[347],"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.",[350],"Achondroplasia",[352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374],"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":377,"type":378},"2026-06-17","ACTUAL",{"date":380,"type":378},"2025-11-19",{"date":382,"type":344},"2032-03",{"name":5,"class":6},13]