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

NCT07187531 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: SAB-142-2012025-521560-36-00U1111-1320-2651
• Study Type: interventional
• Target: 159
• Locations: 14 countries
• Sites: 61

Brief 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).

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)

  From dose administration through Week 4

• Part B: Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)

  This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\] at 12 months)

  From dose administration up to Month 12

Secondary Outcomes (16)

• Part B: Time in tight range (TITR)

  At baseline, Months 3, 6, 9 and 12

• Part B: Haemoglobin A1c (HbA1c) levels

  At baseline, Months 3, 6, 9 and 12

• Part B: Time in range (TIR)

  At baseline, Months 3, 6, 9 and 12

• Part B: Time above range, assessed by CGM

  At baseline, Months 3, 6, 9 and 12

• Part B: Time below range, assessed by CGM

  At baseline, Months 3, 6, 9 and 12

Study Arms (3)

High Dose SAB-142

EXPERIMENTAL

Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.

Drug: High Dose SAB-142

Low Dose SAB-142

EXPERIMENTAL

Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.

Drug: Low Dose SAB-142

Placebo

PLACEBO COMPARATOR

Part B: This is a double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.

Other: Placebo

Interventions

High Dose SAB-142 DRUG

High Dose SAB-142

High Dose SAB-142

Placebo OTHER

Placebo

Placebo

Low Dose SAB-142 DRUG

Low Dose SAB-142

Low Dose SAB-142

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant and/or appropriate legal guardian must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\*, inclusive, at the time of randomisation in Part B.
• Weight ≥16.0 kg at time of randomisation.
• Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. An extension of no more than 14 days is permitted if a participant has planned and/or is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.
• Participant has random C-peptide levels of ≥0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
• Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.
• Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:
• Glutamic acid decarboxylase 65 (GAD65)
• Islet antigen 2 (IA-2)
• Zinc transporter 8 (ZnT8)
• Insulin autoantibodies (if testing within the first 14 days of insulin treatment)
• Female participants:
• a. Must be of nonchildbearing potential, i.e., pre-pubertal\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin \[β-HCG\]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.
• ii. Agree not to become pregnant or donate ova from signing the consent form until the end of study visit.
• iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from signing the consent and for the duration of the study.

You may not qualify if:

• Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications).
• Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
• Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.
• Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
• Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and/or efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.
• Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.
• Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.
• Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.
• 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. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
• Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus \[CMV\], Epstein-Barr Virus \[EBV\] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I/E are met. Participants who have an active infection and/or fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.
• Participant has a diagnosis of significant liver disease or at screening ALT and/or AST \>2× or total bilirubin of \>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and/or indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.
• An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:
• Lymphocyte count: \<1000/μL
• Neutrophil count: \<1500/μL
• Platelet count: \<100 000 platelets/μL

Sponsors & Collaborators

• SAb Biotherapeutics, Inc.: lead

Study Sites (65)

University of California San Francisco Benioff Children's Hospital

San Francisco, California, 94158, United States

NOT YET RECRUITING

University of Colorado - Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

RECRUITING

University of Miami - Gables One Tower

Miami, Florida, 33136, United States

NOT YET RECRUITING

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

Atlanta, Georgia, 30329, United States

NOT YET RECRUITING

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

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

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

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Children's Mercy Hospital Kansas - Pediatric Care Clinic

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

University at Buffalo MD Physicians Group

Buffalo, New York, 14203, United States

NOT YET RECRUITING

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

Chapel Hill, North Carolina, 27514, United States

NOT YET RECRUITING

Sanford Medical Center Fargo

Fargo, North Dakota, 58104, United States

NOT YET RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

NOT YET RECRUITING

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

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Virginia Health System - Pediatric Diabetes Clinic

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101, United States

RECRUITING

Mary Bridge Children's Outpatient Center - Tacoma

Tacoma, Washington, 98405-3720, United States

NOT YET RECRUITING

Queensland Children's Hospital

Brisbane, 4101, Australia

NOT YET RECRUITING

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

Nedlands, 6009, Australia

NOT YET RECRUITING

The Royal Children's Hospital Melbourne

Parkville, 3052, Australia

NOT YET RECRUITING

The Royal Melbourne Hospital (RMH)

Parkville, 3052, Australia

RECRUITING

Royal North Shore Hospital (RNSH)

St Leonards, 2065, Australia

RECRUITING

Westmead Hospital

Westmead, 2145, Australia

NOT YET RECRUITING

Medizinische Universitaet Graz - Klinik fuer Innere Medizin

Graz, 8036, Austria

NOT YET RECRUITING

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

NOT YET RECRUITING

Medizinische Universitaet Graz - Universitaetsklinik fuer Kinder und Jugendheilkunde

Vienna, 1090, Austria

NOT YET RECRUITING

Medizinische Universitaet Wien - Universitaetsklinik fuer Kinder und Jugendheilkunde

Vienna, 1090, Austria

NOT YET RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Groupe sante CHC - Clinique du MontLegia

Liège, 4000, Belgium

NOT YET RECRUITING

Steno Diabetes Center

Herlev, 2730, Denmark

NOT YET RECRUITING

Helsingin Yliopistollinen Keskussairaala

Helsinki, 00029, Finland

NOT YET RECRUITING

Turun Yliopistollinen Keskussairaala (TYKS)

Turku, 20521, Finland

NOT YET RECRUITING

Universite Paris Descartes - Institut Cochin

Paris, 75014, France

NOT YET RECRUITING

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

Paris, 75019, France

NOT YET RECRUITING

Klinikum Augsburg

Augsburg, 86156, Germany

NOT YET RECRUITING

Hannoversche Kinderheilanstalt

Hanover, 30173, Germany

NOT YET RECRUITING

Technische Universität Munich

Oberschleißheim, 85764, Germany

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Turin, 28100, Italy

NOT YET RECRUITING

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

Verona, 37126, Italy

NOT YET RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50161, Lithuania

NOT YET RECRUITING

Waitemata District Health Board- North Shore Hospital

Auckland, 0620, New Zealand

RECRUITING

Aotearoa Clinical Trials

Auckland, 1640, New Zealand

RECRUITING

New Zealand Clinical Research - Christchurch

Christchurch, 8011, New Zealand

NOT YET RECRUITING

Dunedin Hospital

Dunedin, 9016, New Zealand

NOT YET RECRUITING

Waikato Hospital

Hamilton, 3204, New Zealand

NOT YET RECRUITING

Wellington Regional Hospital

Wellington, 6021, New Zealand

NOT YET RECRUITING

Uniwersytecki Szital Klniczny w Opolu

Opole, 46-020, Poland

NOT YET RECRUITING

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

Poznan, 60-572, Poland

NOT YET RECRUITING

Warszawski Uniwersytet Medyczny - Klinika Pediatrii

Warsaw, 02-091, Poland

NOT YET RECRUITING

Instytut Diabetologii

Warsaw, 02-117, Poland

NOT YET RECRUITING

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-172, Poland

NOT YET RECRUITING

University Children's Hospital Ljubljana (UCHL)

Ljubljana, 1525, Slovenia

NOT YET RECRUITING

Hospital de Cruces

Barakaldo, 48903, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

NOT YET RECRUITING

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Noahs Ark Childrens Hospital for Wales

Cardiff, CF14 4XW, United Kingdom

NOT YET RECRUITING

NHS Lothian - Royal Hospital for Sick Children

Edinburgh, EH9 1LF, United Kingdom

NOT YET RECRUITING

Alder Hey Children's NHS Foundation Trust

Liverpool, L12 2AP, United Kingdom

NOT YET RECRUITING

Barts Health NHS Trust - The Royal London Hospital

London, E1 1BB, United Kingdom

NOT YET RECRUITING

University College London Hospitals NHS Foundation Trust - University College Hospital

London, NW1 2PG, United Kingdom

NOT YET RECRUITING

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

Nottingham, NG7 2UH, United Kingdom

NOT YET RECRUITING

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Senior Manager Clinical Operations

CONTACT

1-844-763-1890; SAFEGUARD@sab.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

IT (3); NZ (6); FI (2); BE (3); FR (2); AU (6); PL (5); DE (3); SL (1); GB (8); ES (3); DK (1); US (17); LI (1)