Actively Recruiting
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Led by City of Hope Medical Center · Updated on 2026-05-05
120
Participants Needed
11
Research Sites
266 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
CONDITIONS
Official Title
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with recent-onset stage 3 type 1 diabetes within 6 months before randomization and within 37 days of screening
- At least one positive type 1 diabetes auto-antibody
- Insulin auto-antibodies considered only if exogenous insulin used for less than 10 days at blood draw
- Stimulated C-peptide level of at least 0.2 pmol/mL measured by mixed meal tolerance test before randomization
- Age between 9 and less than 21 years at randomization
- Body weight over 30 kg
- Body mass index below the 95th percentile for age and gender
- Willing to comply with intensive diabetes management
- Female participants not pregnant, willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to mixed meal tolerance tests
- Women of childbearing potential must use accepted birth control methods
- Male participants able to use abstinence or contraception during the study and agree to not donate sperm during treatment and for 90 days after last dose
- Able to provide informed consent and child assent as applicable
- Sufficient cognitive ability to consent
- Able to read and understand English or Spanish
- Fully vaccinated for age and vaccinated for flu if in flu season
- Willing to avoid live vaccines during treatment
- Willing to avoid non-insulin glucose-lowering drugs (e.g., GLP-1 agonists, symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) and off these drugs for at least 30 days before screening
You will not qualify if you...
- Prior treatment with anti-thymocyte globulin or allergy to ATG or rabbit products
- Immunodeficient or clinically significant chronic lymphopenia, leukopenia, neutropenia, thrombocytopenia, anemia, or leukocytosis based on lab values
- Ongoing or recent major infection requiring hospitalization or IV antibiotics within 30 days
- Active signs or symptoms of acute infection at randomization
- Evidence of current or prior tuberculosis, HIV, Hepatitis B or C infections
- History of serious bacterial, viral, fungal, or opportunistic infections
- Active or recent CMV or EBV illness within 30 days or positive CMV/EBV PCR test
- Positive COVID-19 antigen test within 3 days of randomization
- History of significant cardiac disease or abnormal ECG unless cleared by cardiology
- Low blood pressure or pulse below age and gender percentiles
- History of vasovagal syncope related to low blood pressure
- History of malignancies except skin cancer
- Use of immunomodulators, systemic steroids, or prior immunomodulatory research treatments except placebo
- Current or prior use of Teplizumab
- Use of medications affecting glycemia except topical steroids
- Need for beta blockers, seizure medications, antihypertensives, statins, lithium, theophylline, or clonidine during study
- Receipt of live vaccine within 90 days before randomization
- Known hypersensitivity to study medications or components
- Unable to swallow pills
- Allergy to milk or soy proteins in the Boost drink used for testing
- Current use of hydroxyurea or inability to avoid it during study
- Allergy or severe reaction to adhesives or tape used in study
- Participation in other diabetes care or immune modulation research unless placebo
- Medical conditions or medications that may compromise study safety or results such as alcohol or drug abuse, untreated mental illness, liver or kidney disease, other autoimmune diseases except stable treated hypothyroidism, nervous system disorders, history of multiple abdominal surgeries or bowel obstruction risk, or other conditions per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
UCSF
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Barbara Davis Center for Diabetes University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Yale University
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610
Not Yet Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
University of Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
9
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
10
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
11
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
R
Robert Henderson, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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