[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06873035":3,"trial-entities:NCT06873035":315,"trial-summary:NCT06873035":319},{"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":44,"primary_purpose":45,"phases":46,"enrollment_info":49,"interventions":52,"primary_outcomes":64,"secondary_outcomes":71,"sex":85,"minimum_age":86,"maximum_age":87,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":117,"locations":120,"central_contacts":311,"overall_officials":312,"references":313,"see_also_links":314},"NCT06873035","QBGJ398-304","An Interventional Study of Infigratinib in Children With Hypochondroplasia","A Phase 2\u002F3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children With Hypochondroplasia: ACCEL 2\u002F3","ENROLLING_BY_INVITATION","2027-01","2026-05","2026-07-16","2025-04-22","QED Therapeutics, a BridgeBio company","INDUSTRY",true,"ACCEL2\u002F3 is a Phase 2\u002F3 study. The purpose of the Phase 2 portion of the study (ACCEL2\u002F3) is to evaluate the efficacy and safety of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib at one of two doses, who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).","ACCEL 2\u002F3 is a Phase 2\u002F3 study that comprises of 2 portions. The Phase 2 portion is an open-label, portion in children with HCH aged 5 to 11 years old followed by a Phase 3 portion which is double-blind, placebo-controlled in children with HCH aged \\>3 years old to \\\u003C18 years old.",[19],"Hypochondroplasia",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"skeletal dysplasia","endochondral ossification","hypochondroplasia","HCH","shortened proximal limbs","fibroblast growth factor receptor 3","FGFR3","endochondral bone formation","disproportionate short stature","quality of life","dwarfism","bone diseases","musculoskeletal diseases","osteochondrodysplasia","functional abilities","annualized growth velocity","annualized height velocity","growth","genetic diseases","congenital","AHV","AGV","Pathogenic variants","INTERVENTIONAL","TREATMENT",[47,48],"PHASE2","PHASE3",{"count":50,"type":51},24,"ESTIMATED",[53,59],{"type":54,"name":55,"description":56,"armGroupLabels":57},"DRUG","infigratinib 0.128 mg\u002Fkg\u002Fday","Oral infigratinib 0.128 mg\u002Fkg\u002Fday",[58],"Phase 2 Cohort 1",{"type":54,"name":60,"description":61,"armGroupLabels":62},"infigratinib 0.25 mg\u002Fkg\u002Fday","Oral infigratinib 0.25 mg\u002Fkg\u002Fday",[63],"Phase 2 Cohort 2",[65,68],{"measure":66,"timeFrame":67},"Change from baseline (BL) in Annualized Height Velocity (AHV; cm\u002Fyear)","26 weeks",{"measure":69,"timeFrame":70},"Incidence, severity, and seriousness of adverse events (AEs) that require dose reduction or discontinuation","at least 26 weeks",[72,75,77,79,81,83],{"measure":73,"timeFrame":74},"Change from BL in height Z-score (in relation to both HCH and average height tables)","52 weeks",{"measure":76,"timeFrame":74},"Change from BL in upper to lower body segment ratio (cm)",{"measure":78,"timeFrame":74},"Changes in cognitive function (as assessed by age appropriate computerized tests)",{"measure":80,"timeFrame":74},"Pharmacokinetic profile of infigratinib by assessment of maximum concentration (Cmax)",{"measure":82,"timeFrame":74},"Pharmacokinetic profile of infigratinib by assessment of time-to-maximum concentration (Tmax)",{"measure":84,"timeFrame":74},"Change from BL in collagen X marker (CXM) levels","ALL","3 Years","18 Years",false,{"inclusion":90,"exclusion":101,"raw_text":116},[91,92,93,94,95,96,97,98,99,100],"Participants must have completed at least 26 weeks and still be on the observational study (QBGJ398-004).","Phase 2 portion: Participants 5-11 years of age (inclusive).","Phase 3 portion: Participants 3 to \\\u003C18 years of age at screening with growth potential","Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.","Participants are able to swallow oral medication.","Participants and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.","Participants are ambulatory and able to stand without assistance. Sex and Contraceptive\u002FBarrier Requirements","Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.","If sexually active, participants whether male or female, must be willing to use a highly effective method of contraception, as relevant, while taking study drug and for 1 month after the last dose of study drug.","Signed informed consent.",[102,103,104,105,106,107,108,109,110,111,112,113,114,115],"Participants who have ACH or a short stature condition other than HCH.","Significant concurrent disease or condition that, in the view of the investigator and\u002For sponsor, would confound assessment of efficacy or safety of infigratinib.","Current evidence of clinically significant corneal or retinal disorder\u002Fkeratopathy confirmed by ophthalmic examination.","Concurrent circumstance, disease, or condition that, in the view of the investigator and\u002For sponsor, would interfere with study participation or safety evaluations.","History and\u002For current evidence of extensive ectopic tissue calcification.","History of malignancy.","Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH, HCH, or short stature.","Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid.","Previous limb-lengthening surgery at any time or planned\u002Fexpected to have limb-lengthening or guided growth surgery while participating in the study.","Participants receiving medications which could increase serum phosphorus and\u002For calcium concentrations","Clinically significant abnormality in any laboratory test result at screening.","Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study.","Allergy to any components of the study drug.","Concurrent circumstance, disease, or condition that would interfere with study participation.","Key Inclusion Criteria:\n\n* Participants must have completed at least 26 weeks and still be on the observational study (QBGJ398-004).\n* Phase 2 portion: Participants 5-11 years of age (inclusive).\n* Phase 3 portion: Participants 3 to \\\u003C18 years of age at screening with growth potential\n* Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.\n* Participants are able to swallow oral medication.\n* Participants and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.\n* Participants are ambulatory and able to stand without assistance. Sex and Contraceptive\u002FBarrier Requirements\n* Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche.\n* If sexually active, participants whether male or female, must be willing to use a highly effective method of contraception, as relevant, while taking study drug and for 1 month after the last dose of study drug.\n* Signed informed consent.\n\nKey Exclusion Criteria:\n\n* Participants who have ACH or a short stature condition other than HCH.\n* Significant concurrent disease or condition that, in the view of the investigator and\u002For sponsor, would confound assessment of efficacy or safety of infigratinib.\n* Current evidence of clinically significant corneal or retinal disorder\u002Fkeratopathy confirmed by ophthalmic examination.\n* Concurrent circumstance, disease, or condition that, in the view of the investigator and\u002For sponsor, would interfere with study participation or safety evaluations.\n* History and\u002For current evidence of extensive ectopic tissue calcification.\n* History of malignancy.\n* Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH, HCH, or short stature.\n* Regular long-term treatment (≥3 weeks) with supraphysiologic doses of glucocorticoid.\n* Previous limb-lengthening surgery at any time or planned\u002Fexpected to have limb-lengthening or guided growth surgery while participating in the study.\n* Participants receiving medications which could increase serum phosphorus and\u002For calcium concentrations\n* Clinically significant abnormality in any laboratory test result at screening.\n* Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study.\n* Allergy to any components of the study drug.\n* Concurrent circumstance, disease, or condition that would interfere with study participation.",[118,119],"CHILD","ADULT",[121,130,138,146,154,162,170,178,186,195,204,211,219,227,234,241,249,256,264,271,279,287,296,303],{"facility":122,"city":123,"state":124,"zip":125,"country":126,"geoPoint":127},"UCSF Benioff Children's Hospital","Oakland","California","94609","United States",{"lat":128,"lon":129},37.80437,-122.2708,{"facility":131,"city":132,"state":133,"zip":134,"country":126,"geoPoint":135},"Childrens Hospital Colorado","Aurora","Colorado","80045",{"lat":136,"lon":137},39.72943,-104.83192,{"facility":139,"city":140,"state":141,"zip":142,"country":126,"geoPoint":143},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"lat":144,"lon":145},38.89511,-77.03637,{"facility":147,"city":148,"state":149,"zip":150,"country":126,"geoPoint":151},"Johns Hopkins School of Medicine","Baltimore","Maryland","21287",{"lat":152,"lon":153},39.29038,-76.61219,{"facility":155,"city":156,"state":157,"zip":158,"country":126,"geoPoint":159},"University of Missouri","Columbia","Missouri","65201",{"lat":160,"lon":161},38.95171,-92.33407,{"facility":163,"city":164,"state":165,"zip":166,"country":126,"geoPoint":167},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":168,"lon":169},39.12711,-84.51439,{"facility":171,"city":172,"state":173,"zip":174,"country":126,"geoPoint":175},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":176,"lon":177},36.16589,-86.78444,{"facility":179,"city":180,"state":181,"zip":182,"country":126,"geoPoint":183},"University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic","Madison","Wisconsin","53705",{"lat":184,"lon":185},43.07305,-89.40123,{"facility":187,"city":188,"state":189,"zip":190,"country":191,"geoPoint":192},"Murdoch Children's Research Institute - The Royal Children's Hospital Melbourne","Parkville","Victoria","3052","Australia",{"lat":193,"lon":194},-37.78333,144.95,{"facility":196,"city":197,"state":198,"zip":199,"country":200,"geoPoint":201},"London Health Services Centre - Children's Hospital of Western Ontario","London","Ontario","N6C 2R5","Canada",{"lat":202,"lon":203},42.98339,-81.23304,{"facility":205,"city":206,"state":198,"zip":207,"country":200,"geoPoint":208},"Children's Hospital of Eastern Ontario Research Institute","Ottawa","K1H 8L1",{"lat":209,"lon":210},45.41117,-75.69812,{"facility":212,"city":213,"state":214,"zip":215,"country":200,"geoPoint":216},"Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine","Montreal","Quebec","H3T 1C5",{"lat":217,"lon":218},45.50884,-73.58781,{"facility":220,"city":221,"state":222,"zip":223,"country":222,"geoPoint":224},"Hôpital Femme Mère Enfant","Bron","France","69677",{"lat":225,"lon":226},45.73865,4.91303,{"facility":228,"city":229,"state":222,"zip":230,"country":222,"geoPoint":231},"Hôpital Universitaire Necker-Enfants Malades","Paris","75015",{"lat":232,"lon":233},48.85341,2.3488,{"facility":235,"city":236,"state":222,"zip":237,"country":222,"geoPoint":238},"Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants","Toulouse","31059",{"lat":239,"lon":240},43.60426,1.44367,{"facility":242,"city":243,"state":244,"zip":245,"country":244,"geoPoint":246},"Haukeland University Hospital","Bergen","Norway","5021",{"lat":247,"lon":248},60.39299,5.32415,{"facility":250,"city":251,"state":244,"zip":252,"country":244,"geoPoint":253},"Paediatric Clinical Research Unit at Oslo University Hospital","Oslo","0372",{"lat":254,"lon":255},59.91273,10.74609,{"facility":257,"city":258,"state":259,"zip":260,"country":259,"geoPoint":261},"Hospital Pediátrico de Coimbra","Coimbra","Portugal","3000-602",{"lat":262,"lon":263},40.20686,-8.41996,{"facility":265,"city":266,"state":266,"zip":267,"country":266,"geoPoint":268},"KK Women's and Children's Hospital","Singapore","229899",{"lat":269,"lon":270},1.28967,103.85007,{"facility":272,"city":273,"state":274,"zip":275,"country":274,"geoPoint":276},"Unidad de Cirugía Artroscopica, Hopsital MIKS","Vitoria-Gasteiz","Spain","01010",{"lat":277,"lon":278},42.84998,-2.67268,{"facility":280,"city":281,"state":282,"zip":283,"country":282,"geoPoint":284},"Astrid Lindgren Children's Hospital","Solna","Sweden","17164",{"lat":285,"lon":286},59.36004,18.00086,{"facility":288,"city":289,"state":290,"zip":291,"country":292,"geoPoint":293},"Manchester University","Manchester","England","M13 9WL","United Kingdom",{"lat":294,"lon":295},53.48095,-2.23743,{"facility":297,"city":298,"state":290,"zip":299,"country":292,"geoPoint":300},"Sheffield Children's Hospital","Sheffield","S10 2TH",{"lat":301,"lon":302},53.38297,-1.4659,{"facility":304,"city":305,"state":306,"zip":307,"country":292,"geoPoint":308},"Glasgow Clinical Research Facility, Queen Elizabeth University Hospital","Glasgow","Scotland","G51 4TF",{"lat":309,"lon":310},55.86515,-4.25763,[],[],[],[],{"nct_id":4,"conditions":316,"biomarkers":317},[19],[318],"Fibroblast Growth Factor Receptor 3",{"nct_id":4,"found":88,"summary":320,"prompt_version":320},null]