| Outcome Measures: |
Primary: Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC, Baseline to Week 52 | Secondary: Time in range (70-180 mg/dL), assessed by CGM at W52 and W104, At Week 52 and Week 104|Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W52 and W104, mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC, At Week 52 and Week 104|Proportion of participants with reduction from baseline to W52 and W104 of less than 10% in mean 2h MMTT stimulated C-peptide concentration, mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC, From baseline to Week 52 and Week 104|Proportion of participants with partial remission at W52 and W104 (defined as IDAA1c score ≤9.0, where it is calculated as HbA1c [%] + 4x insulin dose [IU/kg/day]), At Week 52 and Week 104|Change from baseline to W52 and W104 in insulin dose [IU/kg/day], From baseline to Week 52 and Week 104|HbA1c level and its change from baseline at W52 and W104, From baseline to Week 52 and Week 104|Proportion of participants with HbA1c ≤6.5% and requiring no injections of exogenous insulin at W52 and W104, At Week 52 and Week 104|Proportion of participants with HbA1c ≤6.5% and requiring ≤0.25 IU of insulin at W52 and W104, At Week 52 and Week 104|Proportion of participants with HbA1c <7% at W52 and W104, At Week 52 and Week 104|Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation, Until Week 130|Number of participants with at least one hypoglycemic event, Until Week 130|Number of participants with at least one hyperglycemic episode, Until Week 130|Number of participants with at least one diabetic ketoacidosis (DKA) event, Until Week 130|Number of participants with clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation, Until Week 130|Height and growth rate over time (for participants <18 y.o. at screening), Until Week 130|Frexalimab plasma concentrations over time, Until Week 104|Incidence of anti-drug antibodies (ADAs) over time, Until Week 130|Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants), From baseline to Week 52 and Week 104|Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants), From baseline to Week 52 and Week 104|Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants), From baseline to Week 52 and Week 104|Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants), From baseline to Week 52 and Week 104|Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.), From baseline to Week 52 and Week 104|Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.), From baseline to Week 52 and Week 104|Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104, Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104|Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC, From baseline to Week 104|Change from baseline to W52 in IDAA1c score, From baseline to Week 52
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| Locations: |
University of California San Francisco - Mission Bay- Site Number : 8400012, San Francisco, California, 94158, United States|University of Colorado - Anschutz Medical Campus- Site Number : 8400003, Aurora, Colorado, 80045, United States|University of Florida College of Medicine- Site Number : 8400010, Gainesville, Florida, 32610, United States|University of Miami Hospital- Site Number : 8400013, Miami, Florida, 33136, United States|AdventHealth Orlando- Site Number : 8400002, Orlando, Florida, 32803, United States|Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009, Idaho Falls, Idaho, 83404, United States|NorthShore University HealthSystem - Skokie- Site Number : 8400007, Skokie, Illinois, 60077, United States|Joslin Diabetes Center - Boston- Site Number : 8400015, Boston, Massachusetts, 02215, United States|University at Buffalo-Jacobs School of Medicine and Biomedical Sciences - Jacobs Multiple Sclerosis Center for Treatment and Research- Site Number : 8400004, Buffalo, New York, 14202, United States|University of North Carolina- Site Number : 8400001, Chapel Hill, North Carolina, 27599, United States|Cincinnati Children's Hospital Medical Center- Site Number : 8400019, Cincinnati, Ohio, 45229, United States|The Children's Hospital of Philadelphia Site Number : 8400005, Philadelphia, Pennsylvania, 19104, United States|University of Texas - Southwestern Medical Center- Site Number : 8400011, Dallas, Texas, 75390, United States|Benaroya Research Institute at Virginia Mason- Site Number : 8400016, Seattle, Washington, 98101, United States|Investigational Site Number : 0560002, Brussels, 1090, Belgium|Investigational Site Number : 0560001, Leuven, 3000, Belgium|Investigational Site Number : 1240001, Vancouver, British Columbia, V5Y 3W2, Canada|Investigational Site Number : 1240007, London, Ontario, N6A 5W9, Canada|Investigational Site Number : 1240005, Montreal, Quebec, H3T 1C5, Canada|Investigational Site Number : 1240004, Montreal, Quebec, H4A 3J1, Canada|Investigational Site Number : 1240003, Montreal, Quebec, H4A 3T2, Canada|Investigational Site Number : 2030001, Prague, 150 06, Czechia|Investigational Site Number : 2080002, Aarhus, 8200, Denmark|Investigational Site Number : 2500004, Corbeil-essonnes, 91106, France|Investigational Site Number : 2500005, Mont-de-marsan, 40024, France|Investigational Site Number : 2500006, Paris, 75679, France|Investigational Site Number : 2500003, Saint-herblain, 44800, France|Investigational Site Number : 2760001, Hannover, 30173, Germany|Investigational Site Number : 2760002, Oldenburg in Holstein, 23758, Germany|Investigational Site Number : 3480001, Balatonfüred, 8230, Hungary|Investigational Site Number : 3480002, Nyíregyháza, 4400, Hungary|Investigational Site Number : 3480006, Székesfehérvár, 8000, Hungary|Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003, Florence, 50139, Italy|Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009, Napoli, 80131, Italy|Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001, Novara, 28100, Italy|Investigational Site Number : 3800005, Novara, 28100, Italy|Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002, Varese, 21100, Italy|Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004, Verona, 37126, Italy|Investigational Site Number : 6160001, Warsaw, Mazowieckie, 02-507, Poland|Investigational Site Number : 6160004, Warsaw, 02-117, Poland|Investigational Site Number : 6160007, Warszawa, 04-730, Poland|Investigational Site Number : 7240003, Seville, Andalucia, 41009, Spain|Investigational Site Number : 7240005, Oviedo, Asturias, 33011, Spain|Investigational Site Number : 7240001, Barcelona, Barcelona [Barcelona], 08035, Spain|Investigational Site Number : 7240002, Esplugues de Llobregat, Catalunya [Cataluña], 08950, Spain|Investigational Site Number : 7240006, Valencia, Valenciana, Comunidad, 46010, Spain|Investigational Site Number : 7240004, Málaga, 29010, Spain|Investigational Site Number : 7240007, Vitoria-gasteiz, Álava, 01009, Spain|Investigational Site Number : 7520001, Stockholm, 113 65, Sweden|Investigational Site Number : 7520003, Stockholm, 118 83, Sweden|Investigational Site Number : 8260003, Birmingham, B15 2TH, United Kingdom|Investigational Site Number : 8260004, Leicester, LE5 4PW, United Kingdom
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