A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab… (NCT07061574) | Clinical Trial Compass
RecruitingPhase 1/2
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
United States120 participantsStarted 2026-03-10
Plain-language summary
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.
Who can participate
Age range9 Years – 21 Years
SexALL
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Key Inclusion Criteria:
Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.
* At least one positive T1D auto-antibody.
* If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.
* Insulin auto-antibodies are only considered if exogenous insulin use is \<10 days when blood is drawn.
* Must have stimulated C-peptide levels ≥0.2 pmol/mL measured during MMTT conducted prior to randomization.
* Age 9 to \<21 years at the time of randomization.
* Body weight \>30kg.
* BMI \<95th percentile for age and gender.
* Willing to comply with intensive diabetes management.
* Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.
* Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral/injection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.
* Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.
* Males must agree to be sexually abstinent or use a condom…