RecruitingPhase 2NCT07187531

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)

Sponsor

SAb Biotherapeutics, Inc.

Enrollment

159 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).

Eligibility

Min Age: 5 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called SAB-142 (anti-thymocyte immunoglobulin), which aims to protect the remaining insulin-producing cells in the pancreas by calming an overactive immune response in people newly diagnosed with Type 1 diabetes. **You may be eligible if...** - You are aged 5–40 (Part B) or 15–40 (Part A) at the time of enrollment - You have been newly diagnosed with Type 1 diabetes within the past 100 days - You still have some insulin-producing ability (confirmed by a C-peptide blood test) - You have at least one Type 1 diabetes-related antibody (like GAD65 or IA-2) - You weigh at least 16 kg **You may NOT be eligible if...** - You have been diagnosed for more than 100 days - You do not have detectable insulin-producing cells remaining - You lack the required antibodies associated with Type 1 diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh Dose SAB-142

High Dose SAB-142

DRUGLow Dose SAB-142

Low Dose SAB-142

OTHERPlacebo

Placebo

Locations(65)

University of California San Francisco Benioff Children's Hospital

San Francisco, California, United States

University of Colorado - Barbara Davis Center for Diabetes

Aurora, Colorado, United States

University of Florida College of Medicine

Gainesville, Florida, United States

University of Miami - Gables One Tower

Miami, Florida, United States

Children's Healthcare of Atlanta (CHOA) - Center for Advanced Pediatrics

Atlanta, Georgia, United States

IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology

Indianapolis, Indiana, United States

Harvard Medical School - Joslin Diabetes Center and Joslin Clinical (JDS)

Boston, Massachusetts, United States

Children's Mercy Hospital Kansas - Pediatric Care Clinic

Kansas City, Missouri, United States

University at Buffalo MD Physicians Group

Buffalo, New York, United States

N.C. Children's Hospital - Children's Specialty Clinics - Chapel Hill at Carolina Pointe II

Chapel Hill, North Carolina, United States

Sanford Medical Center Fargo

Fargo, North Dakota, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Texas Children's Hospital - Clinical Care Center - Pediatric Renal Clinic

Houston, Texas, United States

University of Virginia Health System - Pediatric Diabetes Clinic

Charlottesville, Virginia, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

Mary Bridge Children's Outpatient Center - Tacoma

Tacoma, Washington, United States

Queensland Children's Hospital

Brisbane, Australia

Government of Western Australia - Child and Adolescent Health Service - Perth Children's Hospital

Nedlands, Australia

The Royal Children's Hospital Melbourne

Parkville, Australia

The Royal Melbourne Hospital (RMH)

Parkville, Australia

Royal North Shore Hospital (RNSH)

St Leonards, Australia

Westmead Hospital

Westmead, Australia

Medizinische Universitaet Graz - Klinik fuer Innere Medizin

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Medizinische Universitaet Graz - Universitaetsklinik fuer Kinder und Jugendheilkunde

Vienna, Austria

Medizinische Universitaet Wien - Universitaetsklinik fuer Kinder und Jugendheilkunde

Vienna, Austria

Universitair Ziekenhuis Brussel

Jette, Belgium

UZ Leuven

Leuven, Belgium

Groupe sante CHC - Clinique du MontLegia

Liège, Belgium

Steno Diabetes Center

Herlev, Denmark

Helsingin Yliopistollinen Keskussairaala

Helsinki, Finland

Turun Yliopistollinen Keskussairaala (TYKS)

Turku, Finland

Universite Paris Descartes - Institut Cochin

Paris, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre

Paris, France

Klinikum Augsburg

Augsburg, Germany

Hannoversche Kinderheilanstalt

Hanover, Germany

Technische Universität Munich

Oberschleißheim, Germany

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Turin, Italy

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale della Donna e del Bambino_Borgo Trento

Verona, Italy

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, Lithuania

Waitemata District Health Board- North Shore Hospital

Auckland, New Zealand

Aotearoa Clinical Trials

Auckland, New Zealand

New Zealand Clinical Research - Christchurch

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Waikato Hospital

Hamilton, New Zealand

Wellington Regional Hospital

Wellington, New Zealand

Uniwersytecki Szital Klniczny w Opolu

Opole, Poland

SZPITAL KLINICZNY im. Karola Jonschera - UNIWERSYTETU MEDYCZNEGO im. Karola Marcinkowskiego

Poznan, Poland

Warszawski Uniwersytet Medyczny - Klinika Pediatrii

Warsaw, Poland

Instytut Diabetologii

Warsaw, Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, Poland

University Children's Hospital Ljubljana (UCHL)

Ljubljana, Slovenia

Hospital de Cruces

Barakaldo, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, United Kingdom

Noahs Ark Childrens Hospital for Wales

Cardiff, United Kingdom

NHS Lothian - Royal Hospital for Sick Children

Edinburgh, United Kingdom

Alder Hey Children's NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust - The Royal London Hospital

London, United Kingdom

University College London Hospitals NHS Foundation Trust - University College Hospital

London, United Kingdom

Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)

Nottingham, United Kingdom

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07187531

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