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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial tests two diabetes drugs compared to placebo to see which works best.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
~50
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,314,514 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,904 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have used tobacco or nicotine products as much as smoking more than 5 cigarettes per day.I am up to date on my vaccinations, including the flu shot received at least 2 weeks before my first visit.I have had tuberculosis in the past or currently, confirmed by a skin or blood test.I have heart issues shown on an ECG or a family history of Long QT Syndrome.I am fully vaccinated for COVID-19, including all eligible boosters.I have tested positive for a type of diabetes-related antibody.I was diagnosed with Type 1 Diabetes less than 100 days ago.My C-peptide level was at least 0.2 pmol/mL, 21 days after my diabetes diagnosis.I am a man who will use effective birth control during and for 3 months after treatment.I have tested negative for CMV and EBV recently and haven't shown symptoms for these viruses in the last 30 days.My body weight is at least 35kg.I have not had a heart attack, unstable angina, stroke, or severe heart failure in the last 6 months.My hearing has worsened over the last 5 years, or I've had sudden hearing loss or a diagnosed ear condition.I have not taken antibiotics or antivirals for infections in the last month.I am a poor metabolizer due to a CYP2C19 gene variant.A close family member had a blood clot without any clear reason, suggesting I might have a higher risk of blood clotting issues.Your HbA1c level is less than or equal to 10%.I am between 12 and 35 years old.I have a history of diseases related to lymph nodes or blood cancer.I have not had major surgery or significant trauma in the last month.I do not have signs of an infection right now.I am not taking any immune-suppressing drugs except for inhaled or topical steroids.I need surgery soon or have one scheduled during the study period.I haven't taken diabetes medication that isn't insulin in the last week.My kidney function is reduced.I am taking anti-platelet medication, but not just low dose aspirin.I am using effective birth control methods or abstaining as required.You currently have an active Hepatitis C infection.I have or had a blood clot in my veins or lungs.I have untreated hypothyroidism or active Graves' disease.I am currently diagnosed with COVID-19.You have a history of drinking too much alcohol or using drugs in a harmful way within the past 2 years.I am not pregnant and will use effective birth control during the study.You have a history of widespread herpes zoster or herpes simplex, or you have had multiple episodes of shingles in the same area.Your blood test results show certain values outside the normal range, and you have had certain vaccinations within a specific time period.
Research Study Groups:
This trial has the following groups:- Group 1: Ritlecitinib
- Group 2: Placebo
- Group 3: Abrocitinib
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are persons aged 30 and over eligible to partake in this trial?
"Participants age 12-35 are eligible to join this investigation."
Answered by AI
Is Ritlecitinib a safe intervention for individuals?
"Ritlecitinib was assigned a score of 2 since Phase 2 trials provide some evidence regarding the safety profile, but no data with regard to efficacy."
Answered by AI
What is the scale of this clinical trial?
"Affirmative. The clinical trial information on clinicaltrials.gov shows that this experiment is actively looking for participants, having gone online on August 1st 2023 and last updated on the sixteenth of that month. 78 individuals are required from 3 different sites to complete the study."
Answered by AI
Have recruitments for this trial been opened up already?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is actively searching for participants. The initial posting was issued on August 1st 2023 and the most recent update occurred on August 16th of that same year. 78 individuals must be admitted across 3 separate sites in order for the study to commence properly."
Answered by AI
Is the opportunity to participate in this experiment available at present?
"This trial is accepting applications from 78 individuals diagnosed with Type 1 diabetes, aged 12 to 35. The potential participant must meet a range of criteria including providing informed consent and assent; HbA1c ≤ 10 %; body weight ≥35kg at screening time; CMV and EBV seronegativity within 30 days of randomization (PCR negative); up-to-date on recommended immunizations; willing to comply with intensive diabetes management & wear CGM device etc."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Benaroya Research Institute
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
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