Actively Recruiting
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
Led by SAb Biotherapeutics, Inc. · Updated on 2026-05-12
159
Participants Needed
66
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal guardian has given written informed consent and/or assent
- Male or female aged 15 to 40 years for Part A; 5 to 40 years for Part B
- Weight of at least 16.0 kg at randomization
- Diagnosed with Type 1 Diabetes within 100 days prior to randomization
- Random C-peptide level of at least 0.2 nmol/L during screening
- Completed all scheduled C-peptide samples during mixed meal tolerance test at screening
- Positive test for at least one Type 1 Diabetes-related autoantibody (GAD65, IA-2, ZnT8, or insulin autoantibodies if tested within first 14 days of insulin treatment)
- Female participants must be of nonchildbearing potential or follow contraception requirements if of childbearing potential
- Male participants not sterilised must agree to use contraception and not donate sperm during the study
- Agree to receive required age-appropriate immunisations prior to study drug
- Agree not to receive other experimental treatments during the study
- Suitable venous access for blood sampling
- Willing and able to comply with study assessments and protocol
You will not qualify if you...
- Known allergy or moderate to severe allergic reaction to antibodies, biologics, pork, or study drug components
- Allergy to any required concomitant medications
- Participation in another drug, device, or vaccine clinical trial within 12 weeks before screening
- Prior treatment with teplizumab or investigational anti-CD3 immunomodulatory agents
- Significant uncontrolled medical conditions that may interfere with safety or study results
- Autoimmune diseases other than Type 1 Diabetes managed with systemic immunotherapy except stable thyroid or celiac disease
- Prone to infections or chronic/recurrent infectious diseases
- History or evidence of HIV, hepatitis B or C infection
- Active or latent tuberculosis
- Recent serious infections or symptoms of infection before dosing
- Significant liver disease or abnormal liver function tests
- Abnormal blood counts below specified thresholds
- Recent use of treatments affecting Type 1 Diabetes or immune status including certain drugs
- Current or planned highly restrictive diets affecting well-being or study drug
- Recent or planned vaccinations within specified timeframes
- Lactating females or planning to lactate during study
- History of substance abuse within 12 months prior to screening
- Medical, psychological, or social conditions interfering with study participation
- Employment with the investigator or study site with direct involvement in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
University of California San Francisco Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
2
San Jose Clinical Trials, LLC
San Jose, California, United States, 95128
Actively Recruiting
3
University of Colorado - Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Actively Recruiting
5
University of Miami - Gables One Tower
Miami, Florida, United States, 33136
Not Yet Recruiting
6
Children's Healthcare of Atlanta (CHOA) - Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329
Actively Recruiting
7
IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Harvard Medical School - Joslin Diabetes Center and Joslin Clinical (JDS)
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
9
Children's Mercy Hospital Kansas - Pediatric Care Clinic
Kansas City, Missouri, United States, 64111
Actively Recruiting
10
University at Buffalo MD Physicians Group
Buffalo, New York, United States, 14203
Not Yet Recruiting
11
N.C. Children's Hospital - Children's Specialty Clinics - Chapel Hill at Carolina Pointe II
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
12
Sanford Medical Center Fargo
Fargo, North Dakota, United States, 58104
Not Yet Recruiting
13
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
15
Texas Children's Hospital - Clinical Care Center - Pediatric Renal Clinic
Houston, Texas, United States, 77030
Not Yet Recruiting
16
University of Virginia Health System - Pediatric Diabetes Clinic
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
17
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Actively Recruiting
18
Mary Bridge Children's Outpatient Center - Tacoma
Tacoma, Washington, United States, 98405-3720
Not Yet Recruiting
19
Queensland Children's Hospital
Brisbane, Australia, 4101
Actively Recruiting
20
Government of Western Australia - Child and Adolescent Health Service - Perth Children's Hospital
Nedlands, Australia, 6009
Not Yet Recruiting
21
The Royal Children's Hospital Melbourne
Parkville, Australia, 3052
Not Yet Recruiting
22
The Royal Melbourne Hospital (RMH)
Parkville, Australia, 3052
Actively Recruiting
23
Royal North Shore Hospital (RNSH)
St Leonards, Australia, 2065
Actively Recruiting
24
Westmead Hospital
Westmead, Australia, 2145
Actively Recruiting
25
Medizinische Universitaet Graz - Klinik fuer Innere Medizin
Graz, Austria, 8036
Not Yet Recruiting
26
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Not Yet Recruiting
27
Medizinische Universitaet Graz - Universitaetsklinik fuer Kinder und Jugendheilkunde
Vienna, Austria, 1090
Not Yet Recruiting
28
Medizinische Universitaet Wien - Universitaetsklinik fuer Kinder und Jugendheilkunde
Vienna, Austria, 1090
Not Yet Recruiting
29
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
Not Yet Recruiting
30
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
31
Groupe sante CHC - Clinique du MontLegia
Liège, Belgium, 4000
Not Yet Recruiting
32
Steno Diabetes Center
Herlev, Denmark, 2730
Not Yet Recruiting
33
Helsingin Yliopistollinen Keskussairaala
Helsinki, Finland, 00029
Not Yet Recruiting
34
Turun Yliopistollinen Keskussairaala (TYKS)
Turku, Finland, 20521
Not Yet Recruiting
35
Universite Paris Descartes - Institut Cochin
Paris, France, 75014
Not Yet Recruiting
36
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France, 75019
Not Yet Recruiting
37
Klinikum Augsburg
Augsburg, Germany, 86156
Not Yet Recruiting
38
Hannoversche Kinderheilanstalt
Hanover, Germany, 30173
Not Yet Recruiting
39
Technische Universität Munich
Oberschleißheim, Germany, 85764
Not Yet Recruiting
40
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
41
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Turin, Italy, 28100
Not Yet Recruiting
42
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale della Donna e del Bambino_Borgo Trento
Verona, Italy, 37126
Not Yet Recruiting
43
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania, 50161
Not Yet Recruiting
44
Aotearoa Clinical Trials
Auckland, Auckland, New Zealand, 1640
Actively Recruiting
45
Waitemata District Health Board- North Shore Hospital
Auckland, New Zealand, 0620
Actively Recruiting
46
New Zealand Clinical Research - Christchurch
Christchurch, New Zealand, 8011
Actively Recruiting
47
Dunedin Hospital
Dunedin, New Zealand, 9016
Not Yet Recruiting
48
Waikato Hospital
Hamilton, New Zealand, 3204
Not Yet Recruiting
49
Wellington Regional Hospital
Wellington, New Zealand, 6021
Not Yet Recruiting
50
Uniwersytecki Szital Klniczny w Opolu
Opole, Poland, 46-020
Not Yet Recruiting
51
SZPITAL KLINICZNY im. Karola Jonschera - UNIWERSYTETU MEDYCZNEGO im. Karola Marcinkowskiego
Poznan, Poland, 60-572
Not Yet Recruiting
52
Warszawski Uniwersytet Medyczny - Klinika Pediatrii
Warsaw, Poland, 02-091
Not Yet Recruiting
53
Instytut Diabetologii
Warsaw, Poland, 02-117
Not Yet Recruiting
54
MTZ Clinical Research Sp. z o.o.
Warsaw, Poland, 02-172
Not Yet Recruiting
55
University Children's Hospital Ljubljana (UCHL)
Ljubljana, Slovenia, 1525
Not Yet Recruiting
56
Hospital de Cruces
Barakaldo, Spain, 48903
Not Yet Recruiting
57
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Not Yet Recruiting
58
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Not Yet Recruiting
59
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
60
Noahs Ark Childrens Hospital for Wales
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
61
NHS Lothian - Royal Hospital for Sick Children
Edinburgh, United Kingdom, EH9 1LF
Not Yet Recruiting
62
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Not Yet Recruiting
63
Barts Health NHS Trust - The Royal London Hospital
London, United Kingdom, E1 1BB
Actively Recruiting
64
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom, NW1 2PG
Not Yet Recruiting
65
Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
66
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Not Yet Recruiting
Research Team
S
Senior Manager Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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