JAK Inhibitors for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing two medications, abrocitinib and ritlecitinib, which aim to reduce immune system activity. The study focuses on people who have been recently diagnosed with Stage 3 Type 1 Diabetes. These medications work by calming the immune system to prevent it from attacking insulin-producing cells in the pancreas.
Will I have to stop taking my current medications?
The trial requires that you stop using non-insulin medications that affect blood sugar control within 7 days before screening. Additionally, you cannot be on other immunosuppressive drugs, except for certain inhaled or topical treatments.
Is there safety data available for JAK inhibitors like Abrocitinib and Ritlecitinib?
How is the drug Abrocitinib different from other treatments for type 1 diabetes?
Abrocitinib is a JAK inhibitor, which means it works by blocking certain enzymes (proteins) involved in the immune response, potentially offering a new way to manage autoimmune conditions like type 1 diabetes. Unlike traditional treatments that focus on insulin management, JAK inhibitors target the underlying immune processes, which could help preserve insulin-producing cells.678910
What data supports the effectiveness of JAK inhibitors like Abrocitinib for treating Type 1 Diabetes?
Are You a Good Fit for This Trial?
This trial is for people aged 12-35 with recent Type 1 Diabetes diagnosis. They must have a certain level of C-peptide, weigh at least 35kg, be vaccinated against COVID-19 and other diseases, not pregnant or planning to become so, and willing to use contraception. Exclusions include current participation in another T1D study, certain medical conditions like heart disease or infections, drug abuse history, and specific medication use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily oral administration of either abrocitinib, ritlecitinib, or placebo for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abrocitinib 200 MG Oral Tablet
- Placebo
- Ritlecitinib
Abrocitinib 200 MG Oral Tablet is already approved in European Union, United States for the following indications:
- Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy
- Refractory, moderate-to-severe atopic dermatitis in patients twelve years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University