What is SAB-142 studying for Type 1 Diabetes?

SAB-142 is being studied to evaluate its safety and ability to delay progression in patients with Stage 3 New Onset of Type 1 Diabetes. This trial compares different doses of SAB-142 to a placebo to better understand its effects. The study is sponsored by SAb Biotherapeutics, Inc.

Who may be eligible for this Type 1 Diabetes clinical trial?

Individuals aged 5 to 40 years with a recent diagnosis of Type 1 Diabetes within 100 days may be eligible. Participants must weigh at least 16 kg and be willing to follow study procedures. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Type 1 Diabetes clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses might vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 5Years - 40Years

All Genders

ID07187531

Phase 2b Study of SAB-142 to Slow Progression of Stage 3 New Onset Type 1 Diabetes in Patients Aged 5 to 40

Led by SAb Biotherapeutics, Inc. · Updated on 2026-07-10

159

Participants Needed

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating SAB-142, a human anti-thymocyte immunoglobulin, in patients with Stage 3 New Onset of Type 1 Diabetes NOT1D. This Phase 2b study aims to assess the safety, tolerability, and effectiveness of SAB-142 in delaying disease progression. The trial includes both an open-label and a double-blind, placebo-controlled study design to compare different doses and placebo effects. The study consists of two parts Part A is an open-label, parallel-arm phase, while Part B is a double-blind, placebo-controlled, parallel-arm phase that begins after Part As completion. Participants receive either a high dose or low dose of SAB-142 or a placebo. The study monitors participants over time to evaluate treatment impact and safety. Participants will undergo various assessments including mixed meal tolerance tests, blood tests for C-peptide and autoantibodies, and continuous glucose monitoring at several time points up to 12 months. Safety is assessed by tracking adverse events through Week 4 in Part A and Month 12 in Part B. The trial measures multiple outcomes related to glucose control, insulin use, and immune response to understand the effects of SAB-142.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 40Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant or legal guardian must provide informed consent and understand the trial.
Males and females aged 15-40 years for Part A; 5-40 years for Part B.
Weight of at least 16.0 kg at randomisation.
Diagnosis of Type 1 Diabetes within 100 days before randomisation.
Random C-peptide level of at least 0.2 nmol/L during screening.
Completion of all required C-peptide samples during mixed meal tolerance test.
Positive test for at least one Type 1 Diabetes-related autoantibody.
Female participants must be nonchildbearing or follow contraception requirements.
Male participants must agree to avoid sperm donation and use contraception if applicable.
Agree to age-appropriate immunisations before study drug.
Willing to avoid other experimental immune-modulatory treatments during the study.
Suitable venous access for blood sampling.
Able and willing to follow all assessments and study schedule.

You will not qualify if you...

Allergy or hypersensitivity to antibodies, biologics, pork, or study drug components.
Allergy to required concomitant medications.
Participation in another therapeutic clinical trial within 12 weeks before screening.
Previous treatment with teplizumab or anti-CD3 immunomodulatory drugs.
Significant uncontrolled medical conditions affecting safety or study interpretation.
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.
Serious infections requiring hospitalization or IV treatment within 30 days before screening.
Significant liver disease or abnormal liver function tests.
Abnormal blood counts below specified thresholds.
Recent use of medications affecting immune status or glucose tolerance.
Highly restrictive diets interfering with well-being or study drug.
Recent or planned vaccinations within restricted timeframes.
Lactating females or planning to lactate during the study.
History of alcohol, drug, or chemical abuse within 12 months before screening.
Medical, psychological, or social conditions interfering with study completion.
Employment with study site or investigator with direct study involvement.

Research Team

Senior Manager Clinical Operations

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Phase 2b Study of SAB-142 to Slow Progression of Stage 3 New Onset Type 1 Diabetes in Patients Aged 5 to 40

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AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria