Clinical trial • Phase III • Endocrinology

TEPLIZUMAB for Type 1 diabetes | Stage 3 Type 1 diabetes

Phase III trial of TEPLIZUMAB for Type 1 diabetes | Stage 3 Type 1 diabetes.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Type 1 diabetes | Stage 3 Type 1 diabetes
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
31-07-2025
First CTIS Authorization Date
04-05-2025

Trial design

Randomised, matched placebo for test product; no dose/schedule specified for placebo in available documents-controlled Phase III trial in Netherlands, Greece, Romania and others.

Randomised
Yes
Comparator
Matched placebo for test product; no dose/schedule specified for placebo in available documents
Target Sample Size
566
Trial Duration For Participant
364

Eligibility

Recruits 566 paediatric patients.

Pregnancy Exclusion
A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) OR • Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention
Vulnerable Population
Minors are included (participants 1–25 years). For minor participants a specific ICF must also be signed by the participant’s legally authorized representative (LAR). Age‑specific informed consent / assent documents are provided (examples in documentation: caregiver/parent ICFs and child/adolescent assent/ICFs for age groups 2–6 years, 7–11 years, 12–17 years).

Inclusion criteria

  • {"criterion_text":"- Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.\n- Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.\n- Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Note: For minor participants, a specific ICF must also be signed by the participant’s legally authorized representative (LAR).\n- Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria\n- Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis\n- Participants must be positive for at least one T1D autoantibody at screening: • Glutamic acid decarboxylase (GAD-65), • Insulinoma Antigen-2 (IA-2), • Zinc-transporter 8 (ZnT8), or • Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation). • Islet cell cytoplasmic autoantibodies (ICAs)\n- Have random C-peptide level ≥0.2 nmol/L obtained at screening\n- Both male and female participants are eligible.\n- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) OR • Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention\n- A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention."}

Exclusion criteria

  • {"criterion_text":"- Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.\n- Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status (including but not limited to oral, inhaled or systemically injected steroids with duration >14 days, adrenocorticotropic hormone, verapamil).\n- Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.\n- Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).\n- Participant has previously received teplizumab or other anti-CD3 treatment.\n- Other medications not compatible or interfering with IMP at discretion of Investigator.\n- Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.\n- Participant has any of the following laboratory parameters, at screening prior to first dose: •\tLymphocyte count: <1000/µL, •\tNeutrophil count: <1500/µL, •\tPlatelet count: <150,000 platelets/µL, •\tHemoglobin: <10 g/dL, •\tAspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN), •\tAlanine aminotransferase (ALT) >2.0 × ULN, •\tTotal bilirubin >1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia\n- Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.\n- At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).\n- At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).\n- Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n- Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).\n- Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.\n- Participant has recent or planned vaccinations as follows: •\tLive-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course. •\tInactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.\n- Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline\n- For US and non-EU countries: Total number of days without prandial insulin use\n- For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older\n- For EU countries: HbA1c change from baseline\n- For EU countries: Total number of days without prandial insulin use","definition_or_measurement_approach":"Glycated hemoglobin (HbA1c) change from baseline; Total number of days without prandial insulin use measured as calendar days without prandial insulin; MMTT-stimulated C-peptide concentration change from baseline calculated from AUC over 2-hour MMTT in participants ≥5 years; HbA1c change from baseline; total days without prandial insulin use as above."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC","definition_or_measurement_approach":"Calculated from area under the curve (AUC) of 2-hour MMTT stimulated C-peptide concentration."}
  • {"endpoint_text":"- Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)","definition_or_measurement_approach":"Participants with 2-hour MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L."}
  • {"endpoint_text":"- Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin","definition_or_measurement_approach":"Proportion of participants meeting both HbA1c ≤6.5% and insulin requirement ≤0.25 IU/kg/day."}
  • {"endpoint_text":"- Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM)","definition_or_measurement_approach":"Change in percent time in range (70–180 mg/dL) as measured by CGM."}
  • {"endpoint_text":"- Number of level 2 and 3 (according to American Diabetes Association) hypoglycemic events per participant year (event rates)","definition_or_measurement_approach":"Event rate of ADA level 2 and 3 hypoglycemic events per participant-year."}
  • {"endpoint_text":"- Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation","definition_or_measurement_approach":"Safety endpoints enumerating counts of TEAEs, SAEs, AESIs and TEAEs causing discontinuation."}
  • {"endpoint_text":"- Teplizumab PK parameters: Maximum concentration of teplizumab [Cmax]","definition_or_measurement_approach":"Pharmacokinetic parameter Cmax measured from plasma samples."}
  • {"endpoint_text":"- Teplizumab PK parameters: Area under the curve [AUC] and [AUClast]","definition_or_measurement_approach":"PK AUC and AUClast calculated from plasma concentration-time profiles."}
  • {"endpoint_text":"- Incidence of antidrug-antibodies (ADAs)","definition_or_measurement_approach":"Incidence of detectable antidrug antibodies to teplizumab as measured by immunogenicity assays."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
566
Recruitment Window Months
39
Consent Approach
Adults provide signed informed consent. For minor participants a specific ICF must also be signed by the participant’s legally authorized representative (LAR). Age-specific assent/ICF documents are provided (examples in uploaded materials: pediatric ICFs/assent for 2–6 y, 7–11 y, 12–17 y, caregiver/parent ICFs). Consent/assent materials are available in multiple languages (English, Dutch, French, Greek, Romanian, Polish, Czech, German, Spanish, Italian) as indicated by the language-specific ICF and recruitment documents.

Methods

  • K1/K2 recruitment arrangements documents (country-specific) — includes HCP referral letters for clinicians to refer potential participants
  • Recruitment posters and trifold leaflets (country/language-specific) targeted to patients and caregivers
  • Patient brochures and illustrative books for ages 7–17 to inform children and caregivers
  • Social media captions and digital awareness materials for online recruitment
  • HCP (healthcare professional) outreach including dr-to-dr and HCP referral letters
  • Appointment cards and student/employer/caregiver letters for targeted outreach
  • Electronic prescreener and system emails (Sanofi studies prescreener and mail-from-system) to identify eligible patients
  • Webpage/digital outreach materials and flipcharts for informational sessions

Geography

Total Number Of Sites
76
Total Number Of Participants
504

Netherlands

Earliest CTIS Part Ii Submission Date
28-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
28
Number Of Sites
3
Number Of Participants
26

Sites

Site Name
Meander Medisch Centrum
Department Name
Meander Medisch Centrum
Contact Person Name
Roos Nuboer
Contact Person Email
r.nuboer@meandermc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Leids Universitair Medisch Centrum
Contact Person Name
Eelco DE KONING
Contact Person Email
E.J.P.de_Koning@lumc.nl
Site Name
Diabeter Nederland B.V.
Department Name
Diabeter Nederland B.V.
Contact Person Name
Hj AANSTOOT
Contact Person Email
hjaanstoot@mac.com

Greece

Earliest CTIS Part Ii Submission Date
18-02-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
70
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
General Hospital Of Athens Alexandra
Department Name
Department of Clinical Therapeutics
Contact Person Name
Stavroula Paschou
Contact Person Email
s.a.paschou@gmail.com
Site Name
Hippokration Hospital
Department Name
1st Pediatric Clinic
Contact Person Name
Athanasios Christoforidis
Contact Person Email
christoforidis@doctors.org.uk
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Clinic
Contact Person Name
Vaia Lampadiari
Contact Person Email
vlambadiari@gmail.com
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Department of Endocrinology - Growth & Development
Contact Person Name
Ioanna Kosteria
Contact Person Email
ioannakost@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
18-02-2026
Latest Decision Or Authorization Date
04-05-2025
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Consultmed S.R.L.
Department Name
Diabetes
Contact Person Name
Delia Reurean-Pintilei
Contact Person Email
drdeliapintilei@gmail.com
Site Name
Minimed S.R.L.
Contact Person Name
Roxana Barbu
Contact Person Email
dr.roxanabarbu@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
30-11-2025
Processing Time Days
23
Number Of Sites
7
Number Of Participants
34

Sites

Site Name
Zanamed Medical Clinic Sp. z o.o.
Department Name
Zanamed Medical Clinic Sp z o.o., Al. Zana 32b
Contact Person Name
Daria Gorczyca-Siudak
Contact Person Email
daria.gorczyca@gmail.com
Site Name
Instytut Diabetologii Sp. z o.o.
Department Name
Instytut Diabetologii, ul. Raclawicka 129 lok. 2U
Contact Person Name
Ewa Pankowska
Site Name
Umed Clinical Trials Sp. z o.o.
Department Name
UMED CLINICAL TRIALS Sp. z o.o., ul. Pomorska 251 budynek A-2
Contact Person Name
Agnieszka Szadkowska
Site Name
Centrum Sluchu I Mowy Sp. z o.o.
Contact Person Name
Magdalena Kmiecik
Site Name
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Department Name
Klinika Pediatrii, Endokrynologii,Diabetologii z Pododdzialem Kardiologii , ul. J. Waszyngtona 17
Contact Person Name
Artur Bossowski
Contact Person Email
abossowski@hotmail.com
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Oddzial Kliniczny Diabetologii Dzieciecej i Pediatrii
Contact Person Name
Agnieszka Szypowska
Contact Person Email
aszypowska@wum.edu.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Endokrynologii i Diabetologii
Contact Person Name
Malgorzacie Wajda-Cuszlag
Contact Person Email
m.wajda-cuszlag@ipczd.pl

Belgium

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
30
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pediatry
Contact Person Name
Marieke den Brinker
Contact Person Email
marieke.denbrinker@uza.be
Site Name
UZ Leuven
Department Name
Adult
Contact Person Name
Chantal Mathieu
Contact Person Email
chantal.mathieu@uzleuven.be
Site Name
CHC MontLegia
Department Name
Pediatry
Contact Person Name
Nicole SERET
Contact Person Email
NICOLE.SERET@chc.be
Site Name
UZ Brussel
Department Name
Pediatry
Contact Person Name
Willem STAELS
Contact Person Email
willem.staels@uzbrussel.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pediatry
Contact Person Name
Dominique Beckers
Contact Person Email
dominique.beckers@uclouvain.be
Site Name
UZ Leuven
Department Name
Pediatry
Contact Person Name
Kristina Casteels
Contact Person Email
kristina.casteels@uzleuven.be
Site Name
Hopital Erasme
Department Name
Adult
Contact Person Name
Miriam Cnop
Contact Person Email
miriam.cnop@ulb.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Pediatry
Contact Person Name
Lucia Hajselova
Contact Person Email
lucia.hajselova@hubruxelles.be

Italy

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
40
Number Of Sites
14
Number Of Participants
106

Sites

Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Pediatria
Contact Person Name
Rabbone Ivana
Contact Person Email
ivana.rabbone@uniupo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
UOC Pediatria, UOS diabetologia pediatrica, padiglione NI terzo piano
Contact Person Name
Fortunato Lombardo
Contact Person Email
fortunato.lombardo@polime.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Unità Operativa Complessa di Pediatria
Contact Person Name
Giulio MALTONI
Contact Person Email
giulio.maltoni@aosp.bo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Internal medicine, Endocrine-Metabolic and infectious diseases - Diabetes Unit
Contact Person Name
Raffaella BUZZETTI
Contact Person Email
raffaella.buzzetti@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
U.O.C. Diabetologia e Malattie Metaboliche
Contact Person Name
Laura Nigi
Contact Person Email
laura.nigi@unisi.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOC Clinica Pediatrica - Endocrinologia
Contact Person Name
Marta Bassi
Contact Person Email
martabassi@gaslini.org
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
UOC Diabetologia e Malattie Metaboliche- Ospedale Policlinico
Contact Person Name
Stefano TUMINI
Contact Person Email
stetumin@tin.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
UO Malattie Endocrine e diabetologia
Contact Person Name
Paolo FIORINA
Contact Person Email
paolo.fiorina@unimi.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
UOC Trials Unit
Contact Person Name
Riccardo Schiaffini
Contact Person Email
riccardo.schiaffini@opbg.net
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Pediatria Specialistica U - Dipartimento Patologia e Cura del Bambino - Regina Margherita
Contact Person Name
Luisa De Sanctis
Contact Person Email
luisa.desanctis@unito.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Pediatria B Ospedale della Donna e del bambino
Contact Person Name
Claudio Maffeis
Contact Person Email
claudio.maffeis@univr.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC Diabetologia ed Endocrinologia
Contact Person Name
Lorenzo Lenzi
Contact Person Email
lr.lenzi@meyer.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Pediatrics and Area MAC
Contact Person Name
Chiara Mameli
Contact Person Email
chiara.mameli@unimi.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
UOC Pediatria
Contact Person Name
Stefano Tumini
Contact Person Email
pediatria@asl.pe.it

France

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
142
Number Of Sites
10
Number Of Participants
37

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département d'endocrinologie pédiatrique, gynécologie et diabète
Contact Person Name
Jacques Beltrand
Contact Person Email
jacques.beltrand@aphp.fr
Site Name
Robert Debre University Hospital
Department Name
Département d'endocrinologie pédiatrique et de diabète
Contact Person Name
Elise Bismuth-Reisman
Contact Person Email
elise.bismuth@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Contact Person Name
Anne Vambergue-Libbrecht
Contact Person Email
anne.vambergue@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département d'endocrinologie
Contact Person Name
Jean-Pierre Riveline
Contact Person Email
jeanpierre.riveline@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Division d'endocrinologie pédiatrique et métabolisme
Contact Person Name
Kevin Perge
Contact Person Email
kevin.perge@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Département de diabétologie
Contact Person Name
Pierre Gourdy
Contact Person Email
Gourdy.p@chu-toulouse.fr
Site Name
Centre Hospitalier De Pau
Department Name
Service de pédiatrie
Contact Person Name
Laure Oilleau-Barral
Contact Person Email
laure.oilleau@ch-pau.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Diabétologie
Contact Person Name
Chloé Amouyal
Contact Person Email
chloe.amouyal@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d'endocrinologie, diabète et nutrition
Contact Person Name
Nathalie Jeandidier
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Département de diabétologie
Contact Person Name
Sandrine LABLANCHE
Contact Person Email
SLablanche@chu-grenoble.fr

Spain

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
150
Number Of Sites
17
Number Of Participants
121

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Endocrinology
Contact Person Name
Olga Gonzalez Albarrán
Contact Person Email
ogonzaleza@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric
Contact Person Name
Ana Lucia Gómez Gila
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Pediatric
Contact Person Name
Jose Chamorro Martin
Contact Person Email
jchammart@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pediatric
Contact Person Name
Maria Clemente Leon
Contact Person Email
mclement@vhebron.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pediatric
Contact Person Name
Paloma Cabanas Rodríguez
Site Name
Hospital Universitario De Navarra
Department Name
Pediatric
Contact Person Name
Maria J. Chueca
Site Name
Parc Tauli Hospital Universitari
Department Name
Pediatric
Contact Person Name
Jacobo Perez Sanchez
Contact Person Email
jperezs@tauli.cat
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric
Contact Person Name
Patricia Enes Romero
Contact Person Email
patrienes@gmail.com
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Pediatric
Contact Person Name
Roque Cardona-Hernandez
Contact Person Email
roque.cardona@sjd.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Pediatric
Contact Person Name
Isabel Maria Leiva Gea
Contact Person Email
isabeleivag@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Pediatric
Contact Person Name
Beatriz García Cuartero
Contact Person Email
bgcuartero@salud.madrid.org
Site Name
Hospital Clinico San Carlos
Department Name
Endocrinology
Contact Person Name
Inés Jiménez Varas
Contact Person Email
Ines.jimenes@salud.madrid.org
Site Name
Hospital Universitario Principe De Asturias
Department Name
Endocrinology
Contact Person Name
Marta Botella Serrano
Contact Person Email
marta.botella@salud.madrid.org
Site Name
Hospital Universitario De Cruces
Department Name
Pediatric
Contact Person Name
Itxaso Rica Echevarria
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Endocrinology
Contact Person Name
Nerea Itza Martin
Contact Person Email
nereaitza@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Endocrinology
Contact Person Name
Maria Asuncion Martinez Brocca
Site Name
Hospital Universitario De Canarias
Department Name
Endocrinology
Contact Person Name
Judith Lopez Fernandez
Contact Person Email
judithlf@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
39
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Pediatrická klinika 2. LF UK a FN Motol
Contact Person Name
Zdeněk Šumník
Contact Person Email
zdenek.sumnik@lfmotol.cuni.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Centrum diabetologie
Contact Person Name
Martin Haluzík
Contact Person Email
martin.haluzik@ikem.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
III. interní klinika–klinika endokrinologie a metabolismu
Contact Person Name
Martin Prázný
Contact Person Email
martin.prazny@vfn.cz

Germany

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
104
Number Of Sites
8
Number Of Participants
100

Sites

Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Evangelisches Krankenhaus Bielefeld - Haus Gilead I
Contact Person Name
Norbert Jorch
Contact Person Email
Norbert.Jorch@evkb.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Universitätsklinik Für Kinder- Und Jugendmedizin - Universitaetsklinikum Ulm AöR
Contact Person Name
Christian Denzer
Site Name
Universitaet Leipzig
Department Name
Universitätsklinikum Leipzig
Contact Person Name
Thomas Kapellen
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinikum rechts der Isar Forschergruppe Diabetes at Klinikum rechts der Isar
Contact Person Name
Peter Achenbach
Site Name
Technische Universitaet Dresden
Department Name
Center for Regenerative Therapies Dresden
Contact Person Name
Gita Gemulla
Contact Person Email
gita.gemulla1@tu-dresden.de
Site Name
Medical Center - University Of Freiburg
Department Name
Universitätsklinikum Freiburg
Contact Person Name
Clemens Kamrath
Site Name
Universitaetsklinikum Augsburg
Department Name
Universitaetsklinikum Augsburg
Contact Person Name
Desiree Dunstheimer
Site Name
Hannoversche Kinderheilanstalt
Department Name
Hannoversche Kinderheilanstalt Allg. Pädiatrie/Klin. Forschung
Contact Person Name
Olga KORDONOURI
Contact Person Email
kordonouri@hka.de

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
PPD Development LP
Responsibilities
code:4
Name
Icon Clinical Research Limited
Responsibilities
Home nursing (sponsorDuties code:15)
Name
Eresearchtechnology Inc.
Responsibilities
code:7
Name
Suvoda LLC
Responsibilities
code:3
Name
Labcorp Central Laboratory Services LP
Responsibilities
code:4

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Home nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Lab sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Evidera Limited","duties_or_roles":"Intrial Interview","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Intrial Interview","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Teplizumab
Active Substance
TEPLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
850 µg/ m2 (max daily); max total dose amount 18 gm/m2
Investigational Product Name
Matched placebo for test product
Modality
Other

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