What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes, particularly JAK inhibitors such as Abrocitinib and Ritlecitinib, are associated with several side effects. These include nausea, acne, headache, nasopharyngitis, and flares of the underlying condition. Additionally, there are serious risks such as increased susceptibility to serious infections, major cardiovascular events, cancer, thrombosis, and death. These side effects highlight the need for careful monitoring and consideration when using JAK inhibitors in managing Type 1 Diabetes.

What prior FDA approvals exist?

As of now, there are no FDA-approved JAK inhibitors specifically for the treatment of Type 1 Diabetes. The primary treatments for Type 1 Diabetes include insulin therapy, which is essential for managing blood glucose levels. Other FDA-approved treatments focus on adjunctive therapies such as pramlintide, which is used alongside insulin to help control blood sugar. Research is ongoing to explore the potential of JAK inhibitors like Abrocitinib and Ritlecitinib in modulating the immune response in Type 1 Diabetes, but these are not yet approved for this indication.

What other types of research exist?

Promising novel alternatives to Abrocitinib and Ritlecitinib for Type 1 Diabetes patients include other JAK inhibitors like Tofacitinib and Baricitinib, which have shown efficacy in autoimmune conditions. Additionally, therapies targeting different pathways, such as anti-CD3 monoclonal antibodies (e.g., Teplizumab) and IL-2 receptor agonists, are also being explored for their potential to modulate the immune response and preserve beta-cell function in Type 1 Diabetes.

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Janus Kinase (JAK) Inhibitor

JAK Inhibitors for Type 1 Diabetes

Phase 2

Recruiting

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive for at least one islet cell autoantibody; Glutamate decarboxylase (GAD)65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A

Participants are required to be fully vaccinated including eligible boosters and should receive an authorized non-live COVID-19 vaccination series or COVID-19 vaccine at least 2 weeks prior to the baseline visit (V0)

Must not have

Any present malignancies or history of malignancy, other than a successfully treated nonmelanoma skin cancer

Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

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.

Who is the study for?

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.

What is being tested?

The trial tests two JAK Inhibitors—Abrocitinib and Ritlecitinib—against a placebo in newly diagnosed Type 1 Diabetes patients. It's randomized and double-blind meaning neither the participants nor the researchers know who gets which treatment until after the results are collected.

What are the potential side effects?

Potential side effects of JAK inhibitors may include increased risk of infections due to immune system suppression, changes in blood test results that monitor liver function, cholesterol levels (LDL), potential impact on kidney function as well as possible increase in cancer risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for a type of diabetes-related antibody.

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I am fully vaccinated for COVID-19, including all eligible boosters.

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I was diagnosed with Type 1 Diabetes less than 100 days ago.

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My body weight is at least 35kg.

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I am between 12 and 35 years old.

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I am not pregnant and will use effective birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no current cancers except for treated nonmelanoma skin cancer.

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I have had tuberculosis in the past or currently, confirmed by a skin or blood test.

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I have heart issues shown on an ECG or a family history of Long QT Syndrome.

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I have not taken antibiotics or antivirals for infections in the last month.

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I am a poor metabolizer due to a CYP2C19 gene variant.

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I have a history of diseases related to lymph nodes or blood cancer.

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I do not have signs of an infection right now.

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I am not taking any immune-suppressing drugs except for inhaled or topical steroids.

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I need surgery soon or have one scheduled during the study period.

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My kidney function is reduced.

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I am taking anti-platelet medication, but not just low dose aspirin.

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I have or had a blood clot in my veins or lungs.

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I have untreated hypothyroidism or active Graves' disease.

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I am currently diagnosed with COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The area under the stimulated C-peptide curve (Y_AUC)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: RitlecitinibExperimental Treatment1 Intervention

Ritlecitnib will be self-administered via oral administration as a 100-mg capsule daily for 52 weeks (12 months). The final prepared product is to be labeled to protect the blind.

Group II: AbrocitinibExperimental Treatment1 Intervention

Abrocitinib will be self-administered as 200-milligram (mg) tablet daily for 52 weeks (12 months). The final prepared product is to be labeled to protect the blind.

Group III: PlaceboPlacebo Group1 Intervention

200 mg tablet or 100 mg capsule matching either abrocitinib or ritlecitinib will be self-administered via oral administration daily for 52 weeks (12 months). The final product is to be labeled to protect the blind.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ritlecitinib

2020

Completed Phase 1

~60

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which involves administering insulin to replace the hormone that the body can no longer produce. This is essential for regulating blood glucose levels. Recently, JAK inhibitors like Abrocitinib and Ritlecitinib have been studied for their potential to treat T1D by inhibiting Janus kinase enzymes, which play a role in the immune response. By modulating the immune system, these inhibitors aim to reduce the autoimmune attack on pancreatic beta cells, potentially preserving their function and improving disease outcomes. This approach is significant for T1D patients as it addresses the underlying autoimmune component of the disease, offering a complementary strategy to traditional insulin therapy.

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