A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes

Conditions

• New Onset
• Type 1 Diabetes

Eligibility Criteria

Sex

ALL

Age

9 Years - 20 Years

Healthy Volunteers

Not accepted

Interventions

• Anti-thymocyte globulin (ATG) — DRUG
  ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. The first dose (0.5 mg/kg) will be infused on day 0, during a period of 6 hours. The second dose (2 mg/kg) will be given on day 1, over a period of 4 to 6 hours.
• verapamil extended-release capsule — DRUG
  Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
• Adalimumab — DRUG
  40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.

Study Details

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.

Key Dates

Start date

Mar 10, 2026

Status verified

May 2026

Primary completion

Apr 15, 2030

Completion

Apr 15, 2031

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: ATG + Placebo
  ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). This group will receive Verapamil (Oral) placebo or Adalimumab (injectable) placebo.
• Experimental: ATG + Verapamil
  Low dose ATG (0.5 mg/kg Day 1 then 2 mg/kg Day 2). From the 6-week visit until the 156-week visit, daily oral administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
• Experimental: ATG + Adalimumab
  Low dose ATG (0.5 mg/kg Day 1 then 2 mg/kg Day 2). From the 6-week visit until the 156-week visit, Participants will receive a 40 mg dose injection every other week.

Primary Outcome Measure

Stimulated C-peptide AUC [ Time Frame: Week 104 ]

Central Contacts

• Robert Henderson, MS
  813-975-8690
  [email protected]

Locations (11)

Find similar trials in San Francisco, CA

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