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NCT05743244RECRUITINGIRB Ready

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

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

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 78 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Who Can Participate

Inclusion Criteria

Provide informed consent or assent as appropriate and, if \< 18 years of age have a parent or legal guardian provide informed consent 2. Age 12-35 years (both inclusive) at the time of signing informed consent and assent 3. Diagnosis of T1D within 100 days of the baseline visit (V0). 4. 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 5. Stimulated C-peptide of โ‰ฅ0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes 6. HbA1c โ‰ค 10 % 7. Body weight โ‰ฅ 35kg at screening 8. Willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM) 9. Participants who are Cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) seronegative at screening must be CMV and/or EBV Polymerase chain reaction (PCR) negative within 37 days of randomization and may not

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

78 participants

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Age Range

12 Years - 35 Years

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Gender

ALL

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Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Orange

California

Location available
View Orange location page
Unknown

Palo Alto

California

Location available
View Palo Alto location page
Unknown

San Francisco

California

Location available
View San Francisco location page
Unknown

Aurora

Colorado

Location available
View Aurora location page
Unknown

New Haven

Connecticut

Location available
View New Haven location page
Unknown

Gainesville

Florida

Location available
View Gainesville location page
Unknown

Miami

Florida

Location available
View Miami location page
Unknown

Tampa

Florida

Location available
View Tampa location page
Unknown

Atlanta

Georgia

Location available
View Atlanta location page

๐Ÿ“ And 14 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Type 1 Diabetes Treatment in Orange?

Join others in California exploring innovative treatment options through clinical research

Type 1 Diabetes Treatment Options in Orange, California

If you're searching for Type 1 Diabetes treatment in Orange, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Orange, Palo Alto, San Francisco and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Type 1 Diabetes. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 78 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Type 1 Diabetes?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Type 1 Diabetes

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Type 1 Diabetes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05743244. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.