Join Trial Testing Autoimmune Drugs for Slowing Type 1 Diabetes Progression
A clinical trial is recruiting teens and adults recently diagnosed with type 1 diabetes to test whether medications used to treat certain skin disorders can help people maintain their ability to produce insulin.
Trial status: Recruiting
Clinical Trials Identifier: NCT05743244
Trial Name: Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes
Diabetes Type: Type 1 diabetes
Trial Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Why is this study important?
This study is testing whether two medications, ritlecitinib (brand name Litfulo) and abrocitinib (Cibinqo), can delay or prevent the progression of type 1 diabetes. Ritlecitinib is currently FDA-approved to treat alopecia areata (an autoimmune condition that causes hair loss), and abrocitinib is approved to treat eczema.
While they have slightly different targets, both drugs work by blocking the activities of a family of molecules called Janus kinases (JAKs), which help cells respond to certain signals from the immune system. In the case of an autoimmune disorder where the immune system is mistakenly attacking itself, JAK inhibitors can help break the cycle and get a person’s symptoms under control.
In addition to Litfulo and Cibinqo, there are nine other JAK inhibitors approved to treat various disorders affecting the skin, joints, and digestive system. Now, researchers want to know if these medications could also be used to keep the immune system from destroying insulin-producing cells in the pancreas (beta cells), which causes type 1 diabetes.
There is already some evidence that JAK inhibitors can be an effective treatment for people with diabetes. In 2023, a year-long Australian study showed that baricitinib (Olumiant) – a JAK inhibitor used to treat rheumatoid arthritis and alopecia areata – helped people with recent-onset type 1 diabetes preserve their ability to produce insulin.
How does the trial work?
Researchers are aiming to recruit 78 participants. All of the participants will receive a supply of unlabelled pills that they will each take every day for a year. One third of the participants will receive ritlecitinib, another third will get abrocitinib, and the rest will be given a placebo. Throughout the year and for up to a year afterwards, participants will take frequent tests to assess their immune system and beta cell function.
The researchers will assess the effectiveness of the two JAK inhibitors by measuring each participant’s C-peptide level, which indicates how much insulin the body is producing. The trial is open to teens and adults, although the researchers plan to include more teens than adults.
Are you interested in participating?
You may be eligible to participate if you are between the ages of 12 and 35 and:
- Were diagnosed with type 1 diabetes within 100 days of the start of your participation in the trial
- Are positive for at least one islet cell autoantibody
- Have a stimulated C-peptide level of at least 0.2 pmol/mL
- Have an A1C below 10%
- Are willing to wear a continuous glucose monitor (CGM) and to commit to intensive diabetes management
People who are currently taking any medication other than insulin to manage their glucose levels are not eligible to participate. Additionally, people who are taking immunosuppressive medications like steroids or have an active infection are ineligible as well.
The trial is currently recruiting in several locations throughout the U.S., Australia, and Canada. See a full list of inclusion/exclusion criteria here.
Learn more about type 1 diabetes screening and prevention here: