Type 1 Diabetes Mellitus study: Antithymocyte Globulin vs Teplizumab
Official title Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
ClinicalTrials.gov ID: NCT07216391
What this study is testing
What is Antithymocyte Globulin (ATG)?
An investigational drug being studied for delaying or preventing Stage 3 Type 1 diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether ATG works as well as or better than teplizumab at slowing or stopping the progression to stage 3 type 1 diabetes.
- Who it's for
- It is looking for people who have type 1 diabetes or are at high risk of developing it.
- What's involved
- Participants will receive either two infusions of ATG or fourteen infusions of teplizumab, then be followed with regular visits and tests for at least 12 to 48 months.
- Time commitment
- The study lasts at least 12 to 48 months, with possible extension up to about 9 years for early participants, and requires multiple clinic visits during that time.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 34
You may be able to join if
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age.
- Aged ≥4 to \<35 years
- A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample.
- Participants must meet ADA stage 2 T1D glycemic criteria\ by TrialNet testing within 100 days of the baseline visit.
- Be EBV and CMV PCR negative prior to randomization
You likely can't join if
- Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (\<3,000 leukocytes/μL), neutropenia (\<1,500 neutrophils/μL)...
- Hemoglobin less than 13 g/dL for adult men and less than 11.5g/dL for adult females and less than 11 g/dL for participants under age 18.
- Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.
- Uncontrolled autoimmune thyroid disease and/or celiac disease (participants must be well controlled for the previous 6 months).
- A history of latent or active TB
- Signs and/or symptoms of TB
See the full eligibility criteria
Who can join
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age.
- Aged ≥4 to \<35 years
- A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample.
- Participants must meet ADA stage 2 T1D glycemic criteria\ by TrialNet testing within 100 days of the baseline visit.
- Be EBV and CMV PCR negative prior to randomization
- Be EBV and CMV PCR negative within 2 weeks prior to the baseline visit
- Have no signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days prior to the baseline visit.
- Be at least 8 weeks from last live immunization at the time of the baseline visit.
- Be willing to forgo vaccines (other than non-live influenza and COVID-19) during the 3 months after study drug treatment period and forgo live vaccines for 12 months after study drug treatment period.
- Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).
- With the exception of stage 2 T1D, participants must be healthy, as defined by absence of any other untreated diagnoses that the investigator deems to be a potential confounder.
- If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through the completion of the study infusions and up to 3 months after study drug...
- Must be residing or have accommodations within 1 hour of the infusion site during study drug infusions and must be within 1 hour of a medical care facility for 1 day after completion of infusions.
- Participants must live in a location with rapid access to emergency medical services.
What rules you out
- Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (\<3,000 leukocytes/μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<1000 lymphocytes/μL), thrombocytopenia (\<150,000 platelets/μL).
- Hemoglobin less than 13 g/dL for adult men and less than 11.5g/dL for adult females and less than 11 g/dL for participants under age 18.
- Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.
- Uncontrolled autoimmune thyroid disease and/or celiac disease (participants must be well controlled for the previous 6 months).
- A history of latent or active TB
- Signs and/or symptoms of TB
- Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given
- A history of a chest X-ray consistent with active TB or old, inactive TB, or interferon gamma release assay IGRA (QuantiFERON) test
- A history of a positive purified protein derivative (PPD) skin test result (\>10 mm induration), or positive/repeatedly indeterminate on an interferon-gamma release assay (IGRA; e.g., QuantiFERON-TB test).
- Currently pregnant or lactating or anticipate getting pregnant within the study period.
- Require use of other immunosuppressive agents including chronic use of oral or intravenous injectable steroids.
- Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.
- Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, Down syndrome...
- A history of malignancies other than of skin.
- Evidence of liver dysfunction with AST or ALT ≥ 2 times the upper limit of the reference range.
- Evidence of renal dysfunction with creatinine ≥ 1.5 times the upper limit of the reference range.
- Increased bilirubin ≥ 2 times (total) or ≥ 1.5 times (direct) the normal limit (Participants with documentation of Gilbert's Disease permitted).
- Vaccination with a live vaccine within the last 8 weeks or killed/inactivated vaccine within the last 2 weeks of the baseline visit.
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of screening.
- Prior treatment with Teplizumab or ATG (either in a previous clinical trial or clinically).
- Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.
- Known allergy to rabbits or rabbit derived products.
- Prior adverse reactions to heparin.
- Any condition that in the investigator's opinion may adversely affect study participation.
- Any screening/baseline laboratory result not otherwise stated out of normal reference range and/or medical history that may increase the risk of the participant's participation in this trial.
- Previously diagnosed with Stage 3 TID according to ADA criteria.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 34 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.