78 Participants Needed

JAK Inhibitors for Type 1 Diabetes

Recruiting at 27 trial locations
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MP
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Sandra Lord, MD profile photo
Overseen BySandra Lord, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Abrocitinib has been approved for treating atopic dermatitis in several countries, indicating it has been evaluated for safety in humans. Ritlecitinib has been generally safe and well-tolerated in studies for various conditions, including rheumatoid arthritis and alopecia areata.12345

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?

JAK inhibitors, such as baricitinib, have been shown to be effective in treating several autoimmune diseases by blocking cytokine signaling, although their specific effect on preserving β-cell function in Type 1 Diabetes is still unclear.67111213

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

I am up to date on my vaccinations, including the flu shot received at least 2 weeks before my first visit.
I am fully vaccinated for COVID-19, including all eligible boosters.
I have tested positive for a type of diabetes-related antibody.
See 9 more

Exclusion Criteria

I have no current cancers except for treated nonmelanoma skin cancer.
I haven't needed IV treatment for an infection in the last month.
You have HIV or Hepatitis B infection now or had it in the past.
See 29 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral administration of either abrocitinib, ritlecitinib, or placebo for 12 months

52 weeks
Frequent assessments of insulin production, immunologic status, overall health, and diabetes care

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Abrocitinib 200 MG Oral Tablet
  • Placebo
  • Ritlecitinib
Trial Overview 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.
How Is the Trial Designed?
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.

Abrocitinib 200 MG Oral Tablet is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Cibinqo for:
  • Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy
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Approved in United States as Cibinqo for:
  • 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

Trials
2,513
Recruited
4,366,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Tofacitinib significantly reduced the flare rate in patients with polyarticular course juvenile idiopathic arthritis (JIA), with only 29% of patients on tofacitinib experiencing flares compared to 53% on placebo, indicating its efficacy as a treatment.
The safety profile of tofacitinib was comparable to placebo, with serious adverse events occurring in only 1% of patients on tofacitinib and no deaths reported, suggesting it is a safe option for young patients.
Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial.Ruperto, N., Brunner, HI., Synoverska, O., et al.[2022]
In a phase 2 trial involving 91 patients with recent-onset type 1 diabetes, baricitinib treatment for 48 weeks significantly preserved β-cell function, as indicated by higher C-peptide levels compared to placebo (0.65 vs 0.43 nmol per liter per minute).
Baricitinib also reduced the mean daily insulin dose required by patients, demonstrating its potential efficacy in managing type 1 diabetes without increasing the frequency or severity of adverse events compared to placebo.
Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes.Waibel, M., Wentworth, JM., So, M., et al.[2023]
In a Phase 3 trial involving 797 patients with rheumatoid arthritis who did not respond adequately to methotrexate, tofacitinib (5 or 10 mg twice daily) led to significant improvements in patient-reported outcomes (PROs) after 3 months, which were maintained over 24 months.
Patients receiving tofacitinib reported clinically meaningful enhancements in various aspects of health, including pain and quality of life, compared to those on placebo, with similar improvements observed in patients who switched from placebo to tofacitinib later in the study.
Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study.Strand, V., van der Heijde, D., Tanaka, Y., et al.[2022]

Citations

Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial. [2022]
Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes. [2023]
Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study. [2022]
Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis. [2018]
Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. [2022]
Abrocitinib: First Approval. [2022]
Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. [2023]
Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. [2023]
Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate. [2021]
Ritlecitinib: First Approval. [2023]
[Diagnosis and treatment of rheumatoid arthritis:toward the best practice. Best practice with JAK inhibitors.] [2019]
Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of the Short-, Mid-, and Long-Term Effects of Tofacitinib on Lymphocytes in Patients With Rheumatoid Arthritis. [2020]
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