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AzTrials

Type 1 DiabetesPhase 2SAFEGUARDNCT07187531

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

A Phase 2 study testing High Dose SAB-142 and Low Dose SAB-142 in people with Type 1 Diabetes, run by SAb Biotherapeutics, Inc. at 68 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 40 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
High Dose SAB-142 and Low Dose SAB-142
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
68 sitesin 15 countries
Study dates
25 Nov 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant and/or appropriate legal guardian for participants below the legal age of consent 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. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.
  • 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. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).
  • 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: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy by the time of randomisation. 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.
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  • 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:
  • 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.
  • Agree not to become pregnant or donate ova from the time of signing the consent form until the end of study visit.
  • 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 the time of signing the consent and for the duration of the study.
  • Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)/guardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.
  • Male participants, if not biologically or surgically sterilised, must:
  • Agree not to donate sperm from the time of signing the consent form until EOS.
  • If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from time of signing the consent form until EOS.
  • If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.
  • Prior to receiving study drug, participant must agree to receive locally, regionally and/or country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and/or country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.
  • Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion.
  • Participant has suitable venous access for blood sampling.
  • Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
  • Part C: Participant has completed Month 12 assessments for Part A and Part B and meets all applicable eligibility requirements for participation in Part C.

Who cannot join

  • 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). This includes participants with Hereditary Fructose Intolerance.
  • 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 (Parts A and B) or 28 days prior to Day 1, TP3 (Part C)
  • 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., 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.
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  • 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 enroll 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
  • Haemoglobin: <10 g/dL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and/or is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges.
  • Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.
  • Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists [glucagon-like peptide-1], dipeptidyl peptidase-4 [DPP-IV] inhibitors, or amylin).
  • Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).
  • Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.
  • Recent or planned vaccinations as follows:
  • Countries within EU member states only:
  • Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): From 30 days before dosing through 6 months following administration or SAB-142 for each TP.
  • Recombinant, inactivated or otherwise "non-live" vaccines: From 30 days before dosing or within 60 days following dosing; or planned/required within 30 days prior to or 60 days following Day 1 of TP2.
  • All other countries:
  • Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days following Day 1 of each TP.
  • Recombinant, inactivated or otherwise "non-live" vaccines: Within the 30 days before dosing before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of TP.
  • Female is lactating and/or plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.
  • An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and/or country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit/hyperactivity disorder (ADHD) or others are allowed to participate in the study.
  • An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.
  • An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.
  • An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI, or if participation in the study may place the participant at risk.
  • An individual who has been placed in an institute by official or court order.

Trial locations and contacts

68 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Senior Manager Clinical Operations contact

1-844-763-1890

SAFEGUARD@sab.bio

68 sites in 15 countries

United States22 sites, 21 recruiting

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

    Elvia Padilla, MS, 505-272-3073, epadillamendez@salud.unm.edu

    Recruiting

  • Asheville Clinical Research

    Asheville, North Carolina, 28803

    Jyothsna Paleti, 828-579-2273, jpaleti@ashevilleclinicaltrials.com

    Recruiting

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

    Atlanta, Georgia, 30329

    Linton Cuff, 404-727-1203, linton.carl.cuff@emory.edu

    Recruiting

  • University of Colorado - Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

    Niamh Twiss, 303-724-6774, niamh.twiss@cuanschultz.edu

    Recruiting

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

    Boston, Massachusetts, 02215

    Michelle Zhang, 888-813-8669, T1DTrials@joslin.harvard.edu

    Recruiting

  • University at Buffalo MD Physicians Group

    Buffalo, New York, 14203

    Amanda House, 716-323-0075, ahouse@upa.chob.edu

    Recruiting

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

    Chapel Hill, North Carolina, 27514

    Sherry Bossard, 919-928-5455, sbossard@unc.edu

    Recruiting

  • University of Virginia Health System - Pediatric Diabetes Clinic

    Charlottesville, Virginia, 22903

    Corey Rynders, 434-243-8236, car2r@uvahealth.org

    Recruiting

  • Children's Medical Centre Dallas

    Dallas, Texas, 75235

    Melissa Zamudio, 214-456-8317, melissa.zamudio@childrens.com

    Recruiting

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

    Josie Schahn, 701-234-3722, Josephine.Schahn@SanfordHealth.org

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Tiffany Skrodzi, 682-885-1951, Tiffany.Skrodzi@cookchildrens.org

    Recruiting

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

    Danielle Poulton, (352) 294-5762, Danielle.Poulton@peds.ufl.edu

    Recruiting

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

    Houston, Texas, 77030

    Marion Jose Valladares, 832-824-9316, Marion.Valladares@bcm.edu

    Recruiting

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

    Indianapolis, Indiana, 46202

    Maria Spall, 317-278-7034, malnicho@iu.edu

    Recruiting

  • Children's Mercy Hospital Kansas City - Pediatric Care Clinic

    Kansas City, Missouri, 64111

    Danielle Fleshman, 816-731-7368 ext. 47368, ddfleshman@cmh.edu

    Recruiting

  • University of Miami - Gables One Tower

    Miami, Florida, 33136

    Jhanvi Doshi, 305-243-3306, jxd4468@med.miami.edu

    Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Vaish Bandari, 484-238-6789, bandariv@chop.edu

    Recruiting

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240

    Victoria Rivera, 945-218-5593, vrivera@sanantoniotrials.com

    Recruiting

  • University of California San Francisco Benioff Children's Hospital

    San Francisco, California, 94158

    Karen Ko, 415-514-3730, Karen.ko@ucsf.edu

    Recruiting

  • San Jose Clinical Trials, LLC

    San Jose, California, 95128

    Withdrawn

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

    Solomon Kassa, 206-287-5669, diabetes@benroyaresearch.org

    Recruiting

  • Mary Bridge Children's Outpatient Center - Tacoma

    Tacoma, Washington, 98405-3720

    Rebekah Schaefer, 253-403-0776, becky.schaefer@multicare.org

    Recruiting

Other trials in United States

United Kingdom8 sites, 8 recruiting

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Julie Harris, jh676@medschl.cam.ac.uk

    Recruiting

  • Noahs Ark Childrens Hospital for Wales

    Cardiff, CF14 4XW

    Louise Yendle, 292184816, louise.yendle@wales.nhs.uk

    Recruiting

  • NHS Lothian - Royal Hospital for Sick Children

    Edinburgh, EH9 1LF

    Maxine Ramsay, 0131 312 0203, Maxine.Ramsay@nhs.scot

    Recruiting

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, L12 2AP

    Hannah Leyland, 0151 252 5744, hannah.leyland@alderhay.nhs.uk

    Recruiting

  • Barts Health NHS Trust - The Royal London Hospital

    London, E1 1BB

    Grace Wild, 02035941551, g.wild1@nhs.net

    Recruiting

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG

    Sally Amor, 7929018291, sally.amor2@nhs.net

    Recruiting

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

    Nottingham, NG7 2UH

    Laura Anderson, laura.anderson59@nhs.net

    Recruiting

  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital

    Oxford, OX3 9DU

    Rebecca Law, 441865 857712, rebecca.law@ouh.nhs.uk

    Recruiting

Other trials in United Kingdom

Australia6 sites, 6 recruiting

  • Queensland Children's Hospital

    Brisbane, 4101

    Alison Cook, +61 (07) 3068 3252, Alison.Cook2@health.qld.gov.au

    Recruiting

  • Perth Children's Hospital

    Nedlands, 6009

    Charly Keough, 08 6456 4610, charly.keough@health.wa.gov.au

    Recruiting

  • The Royal Children's Hospital Melbourne

    Parkville, 3052

    Sarah Lee, sarah.lee@mcri.edu.au

    Recruiting

  • The Royal Melbourne Hospital (RMH)

    Parkville, 3052

    Anirudhh Haldar, Anirudhh.haldar@mh.org.au

    Recruiting

  • Royal North Shore Hospital (RNSH)

    St Leonards, 2065

    Seoyoon (Jennie) Lee, +61 2 9463 1864, seoyoon.lee@health.nsw.gov.au

    Recruiting

  • Westmead Hospital

    Westmead, 2145

    Jessica Kim, 02 8890 3413, Jeong.kim@health.nsw.gov.au

    Recruiting

Other trials in Australia

New Zealand6 sites, 6 recruiting

  • Aotearoa Clinical Trials

    Auckland, Auckland, 1640

    Laura Jarrett, laura.jarrett@aotearoatrails.nz

    Recruiting

  • Waitemata District Health Board- North Shore Hospital

    Auckland, 0620

    Narrinder Kaur Shergill, +649 4868920, Narrinder.shergill@waitematadhb.govt.nz

    Recruiting

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011

    Renee Meier, +64 (0) 21 1956579, Renee@edgetrials.co.nz

    Recruiting

  • Dunedin Hospital

    Dunedin, 9016

    Shirley Jones, +64 2108947344, Shirley.jones@otago.ac.nz

    Recruiting

  • Waikato Hospital

    Hamilton, 3204

    Noeleen Cairns, +64 7 8430105, noeleen@clinicaltrialsnz.com

    Recruiting

  • Wellington Regional Hospital

    Wellington, 6021

    Cecilia Ross, +64 4 806 2371, cecilia.ross@ccdhb.org.nz

    Recruiting

Other trials in New Zealand

Austria4 sites, 4 recruiting

  • Medizinische Universitaet Graz - Klinik fuer Innere Medizin

    Graz, 8036

    Siliva Moitzi, +43 316 385 80363, silvia.moitzi@medunigraz.at

    Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

    Eva-Lotte Schwabbehard, +43 50 504 83793, Eva-Lotte.Schwabbehard@i-med.ac.at

    Recruiting

  • Medizinische Universitaet Graz - Universitaetsklinik fuer Kinder und Jugendheilkunde

    Vienna, 1090

    Silvia Moitzi, 4 33164E+12, silvia.moitzi@medunigraz.at

    Recruiting

  • Medizinische Universitaet Wien - Universitaetsklinik fuer Kinder und Jugendheilkunde

    Vienna, 1090

    Teresa Dvoracek, 4 31404E+12, teresa.dvoracek@meduniwien.ac.at

    Recruiting

Other trials in Austria

Poland4 sites, 4 recruiting

  • Uniwersytecki Szital Klniczny w Opolu

    Opole, 46-020

    Angelika Zurawska, 726617898, angelika.zurawska@usk.opole.pl

    Recruiting

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

    Poznan, 60-572

    Maria Buczynska-Gorna, 48 502-584-659, mbuczynska@ump.edu.pl

    Recruiting

  • Instytut Diabetologii

    Warsaw, 02-117

    Marta Puchalska, 48 500 336 605, marta.puchalska@instytutdiabetologii.pl

    Recruiting

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-172

    Agnieszka Danielewicz, 48 502 444 430, angieszka.danielewicz@pratia.com

    Recruiting

Other trials in Poland

Belgium3 sites, 3 recruiting

  • Universitair Ziekenhuis Brussel

    Jette, 1090

    Klara Godderis, +32 2 477 77 60, klara.godderis@uzbrussel.be

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Natalie Van den Driessche, +32 16 34 06 18, natalie.vandendriessche@uzleuven.be

    Recruiting

  • Groupe sante CHC - Clinique du MontLegia

    Liège, 4000

    Alexandra Van Eyck, +32 4 355 4214, Alexandra.vaneyck@chc.be

    Recruiting

Other trials in Belgium

Germany3 sites, 3 recruiting

  • Klinikum Augsburg

    Augsburg, 86156

    Ilona Lindl, 821 400168172, ilona.lindl@uk-augsburg.de

    Recruiting

  • Hannoversche Kinderheilanstalt

    Hanover, 30173

    Karsten Bode, 4.95118E+12, Karsten.Bode@hka.de

    Recruiting

  • Technische Universität Munich

    Oberschleißheim, 85764

    Stefanie Arnolds, 4.08932E+12, stefanie.arnolds@helmholtz-munich.de

    Recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Pauline Grogan, +39 02 2643 5257, grogan.pauline@hsr.it

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

    Turin, 28100

    Elisa Simonini, 39 0321 3733788, elisa.simonini@ext.maggioreosp.novara.it

    Recruiting

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

    Verona, 37126

    Alessia Carpene, 3.9346E+11, alessiacarpene.310@gmail.com

    Recruiting

Other trials in Italy

Finland2 sites, 2 recruiting

  • Helsingin Yliopistollinen Keskussairaala

    Helsinki, 00029

    Elisa Heikkinen, +358 401524099, elisa.heikkinen@hus.fi

    Recruiting

  • Turun Yliopistollinen Keskussairaala (TYKS)

    Turku, 20521

    Annika Adamsson, +358 40 564 4674, annika.adamsson@uti.fi

    Recruiting

Other trials in Finland

France2 sites, 2 recruiting

  • Universite Paris Descartes - Institut Cochin

    Paris, 75014

    Sarah zaimeddine, 01 58 41 33 71, sarah.zaimeddine@aphp.fr

    Recruiting

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

    Paris, 75019

    Laurence Corvez, +33 1 40 03 36 28, laurence.corvez@aphp.fr

    Recruiting

Other trials in France

Spain2 sites, 2 recruiting

  • Hospital de Cruces

    Barakaldo, 48903

    Maitane Gonzalez Arceo, 946 006473, maitane.gonzalezarceo@bio-bizkaia.es

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Maria Luisa Garcia Garcia, 955006685, mlgg.investigacionmacarena@hotmail.com

    Recruiting

Other trials in Spain

Denmark1 site, 1 recruiting

  • Steno Diabetes Center

    Herlev, 2730

    Annette Hillersborg, annette.hillersburg.02@regionh.dk

    Recruiting

Other trials in Denmark

Lithuania1 site, 1 recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161

    Deimante Paskeviciene, 37062048141, deimante.paskeviciene@lsmu.lt

    Recruiting

Other trials in Lithuania

Slovenia1 site, 1 recruiting

  • University Children's Hospital Ljubljana (UCHL)

    Ljubljana, 1525

    Damjana Nikovski, +386 1 522 3903, damjana.nikovski@kclj.si

    Recruiting

Other trials in Slovenia

About this study

Official title: 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)

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
Being tested
High Dose SAB-142, Low Dose SAB-142, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose SAB-142Drug

    High Dose SAB-142

  • Low Dose SAB-142Drug

    Low Dose SAB-142

  • PlaceboOther

    Placebo

Study groups in NCT07187531
Study groupRoleWhat they receive
High Dose SAB-142ExperimentalPart 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. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment.
Receives: Drug: High Dose SAB-142
Low Dose SAB-142ExperimentalPart 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. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment.
Receives: Drug: Low Dose SAB-142
PlaceboPlacebo comparatorPart 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From dose administration through Week 4

  2. 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)

    Measured: From dose administration up to Month 12

  3. Part C: 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 24 months versus control).

    Measured: Baseline and Month 24

Secondary outcomes (16)

  1. Time in tight range (TITR)

    Expressed as a daily average of the percentage of time in a 24hour day a participant's glucose is >70 but ≤140 mg/dL (>3.9 to ≤7.8 mmol/L), assessed using continuous glucose monitoring (CGM)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  2. Haemoglobin A1c (HbA1c) levels

    Expressed in % and mmol/mol

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  3. Time in range (TIR)

    Expressed as a daily average of the percentage of time in a 24-hour day a participant's CGM reading is >70 but ≤180 mg/dL (>3.9 to ≤10.0 mmol/L), assessed by CGM

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  4. Time above range, assessed by CGM

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  5. Time below range, assessed by CGM

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  6. Exogenous insulin use

    Defined as a daily average in units per kilogram per day (U/kg/day) (total daily insulin based on participant's diary at predefined study periods)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  7. Number of clinically important episodes

    Defined as the total number of Level 2 and 3 hypoglycaemic events and/or episodes of cognitive impairment requiring external assistance for recovery (participant's diary and CGM-based)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  8. Proportion of participants with partial clinical remission

    Defined as an insulin requirement of <0.25 units per kg of body weight per day and HbA1c <6.5% (47 mmol/mol)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  9. Proportion of participants with partial remission

    Defined as insulin-dose adjusted A1c (IDAA1c) + [4 × insulin dose (units per kilogram per 24 h) ≤9

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  10. Total BETA-2 score, comprised of fasting plasma glucose (mmol/L), HbA1c (%), daily insulin (U/kg), and fasting C-peptide (nmol/L)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  11. Insulin dose-adjusted A1c (IDAA1C)

    Measured: At baseline, Months 3, 6, 9, 12, 18 and 24

  12. Incidence of TEAEs, AESIs, and SAEs

    Measured: From dose administration through Month 24

  13. SAB-142 serum concentrations

    Measured: Days 1 and 2 of each treatment period (pre- and post- dose/end of infusion [EOI]), plus Weeks 1, 4, and Months 3, 6, 7, 9, 12, 18 and 24

  14. Incidence of anti-SAB-142 antibodies including optional neutralising antibodies (nAbs) in serum

    Measured: At baseline, Weeks 1 and 4, Months 3, 6, 7, 9, 12, 18 and 24

  15. Titres of anti-SAB-142 antibodies including optional neutralising antibodies (nAbs) in serum

    Measured: At baseline, Weeks 1 and 4, Months 3, 6, 7, 9, 12, 18 and 24

  16. Immunophenotyping (IPT)

    Measured: At baseline (Day 1, pre-dose), Week 4, Months 3, 6, 7, 9,12, 18 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start25 Nov 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
159 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187531
Sponsor's protocol ID
SAB-142-201
Other IDs
2025-521560-36-00, U1111-1320-2651, 2025
Acronym
SAFEGUARD
Status last verified
Oct 2026
First submitted
8 Sep 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High Dose SAB-142 and Low Dose SAB-142 in people with Type 1 Diabetes, run by SAb Biotherapeutics, Inc. at 68 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, United Kingdom, Australia, New Zealand, Austria and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Senior Manager Clinical Operations (1-844-763-1890, SAFEGUARD@sab.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) (time frame: From dose administration through Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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