Clinical Study: Type 1 Diabetes (T1D)
TrialNet JAKPOT Study
Study Summary
TrialNet researchers are testing two different treatments – abrocitinib and ritlecitinib – to see if either or both can preserve insulin production in people (ages 12-35) newly diagnosed with type 1 diabetes (Stage 3 T1D).
Abrocitinib and ritlecitinib are in a new class of autoimmune treatments called Janus kinase (JAK) inhibitors. Abrocitinib is approved by the U.S. Food and Drug Administration (FDA) to treat eczema. Ritlecitinib is being studied as a treatment for several autoimmune diseases, including alopecia, ulcerative colitis, Crohn’s disease, vitiligo and rheumatoid arthritis.
Researchers believe abrocitinib and ritlecitinib may be able to calm the immune system response that harms beta cells. Located in the pancreas, beta cells are responsible for making insulin. Continuing to make even a small amount of insulin helps keep blood glucose levels in the normal range, lowering the risk of long-term complications.
As with any medical intervention, there are benefits and risks to participating in this study. Before you join the study, a TrialNet team member will explain all potential benefits and risks and answer your questions.
Eligibility Criteria
You may be eligible to participate if you are:
- Age 12-35
- Newly diagnosed with T1D (in past 3 months)
- Up to date on required vaccines (including the flu vaccine when it is available)
- Not pregnant, breastfeeding or planning to become pregnant while in the study
- AND have:
- One or more diabetes-related autoantibodies
- Hemoglobin A1C below 10%
- C-peptide detectable during a mixed-meal tolerance test (MMTT)
What will study participants be asked to do?
JAKPOT is a two-year study:
- There is a one-year treatment period with daily oral tablets and clinic visits every three months.
- There is a one-year follow-up period with clinic visits every six months.
- All participants will receive guidance for intensive diabetes management and will be expected to wear a Continuous Glucose Monitor (CGM) for 2 weeks after each study visit.
For more information visit: https://trialnet.org/jakpot-t1d
