Clinical trial • Phase II • Endocrinology
HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE for Type 1 diabetes
Phase II trial of HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE for Type 1 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes
- Trial Stage
- Phase II
- Drug Modality
- Other antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 29-09-2025
- First CTIS Authorization Date
- 02-02-2026
Trial design
Randomised, sodium chloride (placebo) — solution for infusion; intravenous use; dosing fields provided in product record (dose uom ml, max daily dose 500 ml, max total dose 1000 ml) (placebo comparator)-controlled Phase II trial in France, Lithuania, Slovenia and others.
- Randomised
- Yes
- Comparator
- SODIUM CHLORIDE (placebo) — solution for infusion; intravenous use; dosing fields provided in product record (dose UOM ml, max daily dose 500 ml, max total dose 1000 ml) (placebo comparator)
- Target Sample Size
- 124
Eligibility
Recruits 124 paediatric patients.
- Pregnancy Exclusion
- If female, participants must meet conditions that prevent pregnancy during the study (for example, not having started menstruation, being post‑menopausal, having had certain surgeries, or using reliable birth control)
- Vulnerable Population
- Vulnerable populations include children and adolescents (paediatric population). Country-specific subject information sheets and informed consent/assent forms are provided (examples: Child Assent, Adolescent Assent, Parent/Guardian ICF, Guardian ICF, Majoritiy age forms). Age-group specific assent forms exist (e.g. 5-6 yrs, 7-11 yrs, 9-11 yrs, 12-14 yrs, 15-17 yrs, adolescent/teen forms) and parent/guardian consent forms are provided. Consent for adults is via the main ICF; minors require parental/guardian consent plus assent appropriate to age; separate materials (including pregnancy/pregnant partner forms) are provided. Documents are available in multiple country languages as part of country recruitment packages.
Inclusion criteria
- {"criterion_text":"- Participants must be up to 40 years old and recently diagnosed with Stage 3 type 1 diabetes\n- Participants must be up to date with vaccines required by local or national health authorities\n- If female, participants must meet conditions that prevent pregnancy during the study (for example, not having started menstruation, being post‑menopausal, having had certain surgeries, or using reliable birth control)\n- Participants must have a positive test for at least one antibody linked to type 1 diabetes\n- Participants must agree not to take part in other experimental treatments during the study."}
Exclusion criteria
- {"criterion_text":"- Participants cannot have a known allergy or severe reaction to similar medicines or any ingredient in the study treatment\n- Participants cannot have taken part in another clinical trial within a set period before joining this study\n- Participants cannot have another autoimmune disease that requires immune system affecting treatment (except stable thyroid or celiac disease)\n- Participants cannot have serious health problems affecting the heart, liver, kidneys, or immune system, or have uncontrolled diabetes complications\n- Participants cannot have certain infections such as HIV, hepatitis B, or hepatitis C"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Recording and reviewing any health problems or side effects that occur during the study","definition_or_measurement_approach":""}
- {"endpoint_text":"- Checking measures of pancreas function related to insulin production","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Monitoring blood sugar control, including information from continuous glucose monitoring devices","definition_or_measurement_approach":""}
Recruitment
- Registry Or Advocacy Recruitment
- True — advocacy outreach materials are included in country recruitment packages (no specific advocacy organisation names are provided in the record)
- Digital Remote Recruitment
- True — digital/remote methods include patient/investigator portals, video materials (video transcripts), online banners, digital flyers, and a Consent Navigator tool; country-specific digital materials available.
- Planned Sample Size
- 124
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent is handled with adult ICFs for adults and parent/guardian ICFs for minors; assent forms are provided for children and adolescents by age group (child assent, adolescent assent, age-specific assent for e.g. 5-6, 7-11, 9-11, 12-14, 15-17). Additional forms include guardian notifications, pregnant partner ICFs, and majority-age forms. Documents are provided in multiple languages (examples present in the dossier: English, French, German, Spanish, Italian, Lithuanian, Slovenian, Polish, Finnish, Dutch/Belgian variants) and country-specific SIS/ICF packages are listed per participating Member State.
Methods
- Country-specific recruitment arrangements (K1 documents) — local site recruitment procedures in each participating country.
- Advocacy outreach materials (K2 Advocacy Outreach) — targeted outreach via patient advocacy channels (materials present for multiple countries).
- Patient flyers and brochures (K2 Patient Flyer / Patient Brochure) — printed/digital leaflets targeted at patients and caregivers, available country-specifically (examples: FR, LT, SI, ES, PL, IT, DE, FI, AT, BE, DK).
- Banners and advertisements (K2 Banners) — online/offline banner adverts for patient recruitment.
- Video outreach (K2 Video Transcript) — video materials/transcripts used for recruitment outreach.
- Consent Navigator (K2 Safeguard Consent Navigator) — tool to support informed consent process.
- Investigator / Patient portals and outreach (sponsor third-party duties mention Investigator/Patient Portals) — digital portals to engage potential participants.
- Central outreach/translation support (third-party duties: translation services) — translation/localisation of materials to local languages.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 66
France
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 22
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Diabetology and Clinical Immunology
- Contact Person Name
- Roberto Mallone
- Contact Person Email
- roberto.mallone@inserm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pediatric Endocrinology and Diabetes
- Contact Person Name
- Elise Bismuth-Reisman
- Contact Person Email
- elise.bismuth@aphp.fr
Lithuania
- Earliest CTIS Part Ii Submission Date
- 07-01-2026
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Endocrinology Department
- Contact Person Name
- Rasa Verkauskiene
- Contact Person Email
- rasa.verkauskiene@kaunoklinikos.lt
Slovenia
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- Šmigoc Schweiger
- Contact Person Name
- Darja Šmigoc Schweiger
- Contact Person Email
- darja.smigoc@kclj.si
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Endocrinology
- Contact Person Name
- Maria Asunción Martinez-Brocca
- Contact Person Email
- masuncion.martinez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Endocrinology
- Contact Person Name
- Nuria Valdés Gallego
- Contact Person Email
- nuria.valdesgallego@kclj.si
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Endocrinology
- Contact Person Name
- Francisco Tinahones Madueno
- Contact Person Email
- fjtinahones@uma.es
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Steno Diabetes Center Copenhagen
- Department Name
- Translational Clinical Research, Paediatrics
- Contact Person Name
- Jesper Johannesen
- Contact Person Email
- jesper.johannesen@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 17
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- UZ Brussel
- Department Name
- Endocrinology
- Contact Person Name
- Bart Keymeulen
- Contact Person Email
- bart.keymeulen@uzbrussel.be
- Site Name
- CHC MontLegia
- Department Name
- Pediatry
- Contact Person Name
- Nicole Seret
- Contact Person Email
- nicole.seret@chc.be
- Site Name
- UZ Leuven
- Department Name
- Endocrinology
- Contact Person Name
- Chantal Mathieu
- Contact Person Email
- chantal.mathieu@uz.kuleuven.ac.be
Poland
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 08-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Mtz Clinical Research Powered By Pratia
- Contact Person Name
- Lidia Groele
- Contact Person Email
- lidia.groele@uckwum.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Dziecięcy SK im. JP Br., Klinika Diabetologii Dziecięcej Pediatrii
- Contact Person Name
- Agnieszka Szypowska
- Contact Person Email
- agnieszka.szypowska@wum.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Opolu
- Department Name
- Oddział Pediatrii
- Contact Person Name
- Agata Chobot
- Contact Person Email
- pediatria@usk.opole.pl
- Site Name
- Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
- Department Name
- Klinika Diabetologii, Auksologii i Otyłości Wieku Rozwojowego
- Contact Person Name
- Elżbieta Niechciał
- Contact Person Email
- eniechcial@um.edu.pl
- Site Name
- Instytut Diabetologii Sp. z o.o.
- Contact Person Name
- Ewa Pańkowska
- Contact Person Email
- ewa.pankowska@instytutdiabetologii.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 105
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- U.O. Medicina
- Contact Person Name
- Sabina Martinenghi
- Contact Person Email
- martinenghi.sabina@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Pediatria
- Contact Person Name
- Ivana Rabbone
- Contact Person Email
- Ivana.rabbone@uniupo.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Ospedale della Donna e del Bambino - U.O.C. Pediatria B
- Contact Person Name
- Claudio Maffeis
- Contact Person Email
- claudio.maffeis@univr.it
Germany
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Hannoversche Kinderheilanstalt
- Department Name
- Paediatric Endocrinology & Diabetology
- Contact Person Name
- Felix Reschke
- Contact Person Email
- Felix.Reschke@hka.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Pediatrics and Adolescent Medicine
- Contact Person Name
- Desiree Dunstheimer
- Contact Person Email
- desiree.dunstheimer@uk-augsburg.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Institute of Diabetes Research
- Contact Person Name
- Anette-Gabriele Ziegler
- Contact Person Email
- anette-g.ziegler@helmholtz-muenchen.de
Finland
- Earliest CTIS Part Ii Submission Date
- 08-01-2026
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Turku University Hospital
- Department Name
- Pediatric Department
- Contact Person Name
- Jaakko Koskenniemi
- Contact Person Email
- jajoko@utu.fi
- Site Name
- HUS-yhtymae
- Department Name
- Pediatric Department
- Contact Person Name
- Mari-Anne Pulkkinen
- Contact Person Email
- mari.pulkkinen@hus.fi
Austria
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 07-02-2026
- Processing Time Days
- 12
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Pediatrics
- Contact Person Name
- Birgit Rami-Merhar
- Contact Person Email
- birgit.rami@meduniwien.ac.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Pediatrics 1
- Contact Person Name
- Sabine Hofer
- Contact Person Email
- sabine.e.hofer@i-med.ac.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Pediatrics
- Contact Person Name
- Elke Froehlich-Retierer
- Contact Person Email
- elke.froehlich-reiterer@medunigraz.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Internal Medicine
- Contact Person Name
- Thomas Pieber
- Contact Person Email
- thomas.pieber@medunigraz.at
Sponsor
Primary sponsor
- Full Name
- Sab Biotherapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Operational study activities (multiple duties listed in sponsor record as codes and roles; contact: submissions@fortrea.com)
- Name
- Almac Clinical Services (Ireland) Limited
- Responsibilities
- Clinical services (duty code present in sponsor record)
Third parties
- {"country":"United Kingdom","full_name":"Greens","duties_or_roles":"Central Printing","organisation_type":"Industry"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Meeting planning, patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Investigator/ Patient Portals","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Multiple operational responsibilities (listed as codes in sponsor record)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Precision Digital Health Inc.","duties_or_roles":"Central Glucose Monitoring (CGM)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"Translation services","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SAB-142
- Active Substance
- HUMAN POLYCLONAL IMMUNOGLOBULIN G AGAINST THYMOCYTE
- Modality
- Other antibody
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Maximum Dose
- 1000 ml (max total), max daily 500 ml
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