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NCT06111586RECRUITINGIRB Ready

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

(FABULINUS)

Sponsored by Sanofi

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 192 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

This is a randomized, parallel group, double-blind Phase 2 study with a 52-week blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment.

Who Can Participate

Inclusion Criteria

Participants who meet the criteria of T1D according to American Diabetes Association
Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).
Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy
one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or
continuous subcutaneous insulin infusion (CSII)
Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:
Glutamic acid decarboxylase (GAD-65)
Insulinoma Antigen-2 (IA-2)
Zinc-transporter 8 (ZnT8) or
Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
Have random C-peptide levels โ‰ฅ 0.2 nmol/L determined at screening visit.
Be vaccinated according to the local vaccination schedu

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

192 participants

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Age Range

12 Years - 35 Years

โšง

Gender

ALL

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Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Gainesville

Florida

Location available
View Gainesville location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Orlando

Florida

Location available
View Orlando location page
RECRUITING

Idaho Falls

Idaho

Location available
View Idaho Falls location page
RECRUITING

Skokie

Illinois

Location available
View Skokie location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Buffalo

New York

Location available
View Buffalo location page

๐Ÿ“ And 5 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 San Francisco?

Join others in California exploring innovative treatment options through clinical research

Type 1 Diabetes Treatment Options in San Francisco, California

If you're searching for Type 1 Diabetes treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco, Denver, Gainesville 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 192 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: NCT06111586. 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.