Clinical trial • Phase III • Endocrinology

Teplizumab for Type 1 diabetes mellitus

Phase III trial of Teplizumab for Type 1 diabetes mellitus. None/Not specified-controlled. 122 participants.

Overview

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

Key dates

Initial CTIS Submission Date
16-09-2024
First CTIS Authorization Date
10-10-2024

Trial design

None/Not specified-controlled Phase III trial across 16 sites in France, Germany, Czechia and others.

Comparator
None/Not specified
Target Sample Size
122
Trial Duration For Participant
1260

Eligibility

Recruits 122 paediatric patients.

Vulnerable Population
The trial includes children and adolescents (minors). Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. Written informed consent must be provided (within 12 months of Week 78 in the parent PRV-031-001 study); where possible, consent/assent for the extension should be obtained at the final (Week 78) visit in the parent study. Age‑specific information/consent and assent documents are provided (assent forms for 9-12 and 13-17 years, parent/guardian and adult ICFs).

Inclusion criteria

  • {"criterion_text":"- Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered\n- Provide written informed consent within 12 months of the Week 78 in the PRV- 031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study"}

Exclusion criteria

  • {"criterion_text":"- Premature discontinuation from the PRV-031-003 (PROTECT) study for any reason"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies","definition_or_measurement_approach":"Incidence (occurrence) of AEs, SAEs and AESIs reported during follow-up, including infections and malignancies (as stated: 'Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies')."}

Secondary endpoints

  • {"endpoint_text":"- The area under the time-versus-concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT), a measure of endogenous insulin production and β cell function by visit and change from baseline (MMTT), a measure of endogenous insulin production and β cell function","definition_or_measurement_approach":"AUC of C-peptide after a 4-hour MMTT by visit and change from baseline; used as a measure of endogenous insulin production and β-cell function (as stated)."}
  • {"endpoint_text":"- Insulin use, defined as a daily average dose in units per kilogram per day (U/kg/day) by visit and change from baseline","definition_or_measurement_approach":"Daily average insulin dose expressed as units/kg/day by visit and change from baseline (as defined)."}
  • {"endpoint_text":"- HbA1c levels(%) by visit and change from baseline","definition_or_measurement_approach":"HbA1c percent measured by visit and reported as change from baseline (as stated)."}

Recruitment

Planned Sample Size
122
Recruitment Window Months
61
Consent Approach
Written informed consent must be provided within 12 months of the Week 78 visit in the parent PRV-031-001 study. Written assent is obtained for participants under 18 years at enrollment according to applicable regulations. If possible, consent and/or assent for the extension should be obtained at the final (Week 78) visit of the parent study. Age-specific ICFs and assent forms are provided (documents for adults, parents, assent 9-12 yrs, assent 13-17 yrs). Subject information/consent documents are available in multiple languages (English, French, German, Polish, Czech, Dutch/Belgian variants as indicated by available documents).

Geography

Total Number Of Sites
16
Total Number Of Participants
66

France

Earliest CTIS Part Ii Submission Date
11-08-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
61
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hôpital de la Timone Enfants, Service de Pédiatrie Multidisciplinaire
Contact Person Name
Rachel REYNAUD
Contact Person Email
rachel.reynaud@ap-hm.fr
Site Name
Hopital Necker Enfants Malades
Department Name
Service d’Endocrinologie, Gynécologie et Diabétologie Pédiatrique
Contact Person Name
Jacques BELTRAND
Contact Person Email
jacques.beltrand@aphp.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
Centre Hospitalier Universitaire De Dijon
Department Name
Bourgogne - Site Francois Mitterand
Contact Person Name
Candance BEN SIGNOR
Contact Person Email
candace.bensignor@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Service de Pédiatrie
Contact Person Name
Stephane PERDEREAU
Site Name
Hospital Femme Mere Enfant
Department Name
Groupe Hospitalier Est, Service d'Endocrinologie et Métabolisme Pédiatrique, 59 Boulevard Pinel
Contact Person Name
Marc NICOLINO
Contact Person Email
marc.nicolino@chu-lyon.fr

Germany

Earliest CTIS Part Ii Submission Date
11-08-2024
Latest Decision Or Authorization Date
16-10-2024
Processing Time Days
66
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Kinderzentrum Bethel; Haematologie/Onkologie
Contact Person Name
Norbert Jorch
Contact Person Email
kinderklinik@evkb.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Paediatrisches Klinisch-Pharmakologisches Studienzentrum (paedKliPS) Zentrum für Kinder- und Jugendm
Contact Person Name
Kristine Chobanyan-Juergens
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik fuer Kinder- und Jugendmedizin
Contact Person Name
Reinhard Berner
Contact Person Email
info@ukdd.de
Site Name
Universitaetsklinikum Augsburg
Department Name
I. Klinik fuer Kinder und Jugendliche
Contact Person Name
Desiree Dunstheimer
Contact Person Email
diabetes-kids@uk-augsburg.de

Czechia

Earliest CTIS Part Ii Submission Date
11-08-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
61
Number Of Sites
1
Number Of Participants
19

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
studie@fnmotol.cz

Belgium

Earliest CTIS Part Ii Submission Date
11-08-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
60
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Diabétologie et endocrinologie pédiatrique
Contact Person Name
Dominique Beckers
Contact Person Email
dominique.beckers@uclouvain.be

Poland

Earliest CTIS Part Ii Submission Date
11-08-2024
Latest Decision Or Authorization Date
16-10-2024
Processing Time Days
66
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Endokrynologii i Diabetologii, Oddział Diabetologii, Poradnia Diabetologiczna
Contact Person Name
Małgorzata Wajda-Cuszlag
Contact Person Email
badania.kliniczne@ipczd.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Dziecięcy Szpital Kliniczny im.J.P.Brudzińskiego,Oddz. Kliniczny Diabetologii Dziecięcej i Pediatrii
Contact Person Name
Agnieszka Szypowska
Contact Person Email
badania.kliniczne@uckwum.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Pediatrii, Diabetologii i Endokrynologii
Contact Person Name
Małgorzata Myśliwiec
Contact Person Email
info@uck.gda.pl
Site Name
Instytut Diabetologii Sp. z o.o.
Department Name
Instytut Diabetologii, Poradnia Diabetologiczna, Poradnia Diabetologiczna dla Dzieci
Contact Person Name
Ewa Pańkowska

Sponsor

Primary sponsor

Full Name
Provention Bio Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Psi Cro AG
Responsibilities
codes: 1,11,12,13,15 (TMF management),2,5,6,7
Name
Parexel International (IRL) Limited
Responsibilities
code: 8
Name
Rho Inc.
Responsibilities
code: 10
Name
Q Squared Solutions Limited
Responsibilities
code: 4

Third parties

  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"codes: 1,11,12,13,15 (TMF management),2,5,6,7","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code: 15 (Biological sample management, storage)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Rho Inc.","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code: 15 (eDiary/eCOA)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Teplizumab
Active Substance
Teplizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
1
Maximum Dose
Maximum daily dose: 850 µg/ m2; Maximum total dose: 18 mg/m2

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