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Monoclonal Antibodies

Frexalimab + Insulin for Type 1 Diabetes (FABULINUS Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

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)

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52 and week 104

Awards & highlights

FABULINUS Trial Summary

This trial evaluates safety/efficacy of frexalimab in adults & teens w/ newly diagnosed Type 1 Diabetes, comparing 3 age-adjusted dose-levels with placebo. Will assess preservation of insulin secretion, and determine dose-response & minimal efficacious dose. Up to 135 weeks total duration.

Who is the study for?

The FABULINUS trial is for young individuals with newly diagnosed Type 1 Diabetes. Participants must be between 12-21 years old, vaccinated according to local schedules, and have started insulin therapy within the last 90 days. They should test positive for certain diabetes-related autoantibodies and agree to use contraception.Check my eligibility

What is being tested?

This study tests Frexalimab's safety and effectiveness in preserving natural insulin production compared to a placebo in youths on standard insulin treatment. It's a double-blind Phase 2 trial with two parts: initial dose safety assessment followed by dose-finding over up to 104 weeks of treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Frexalimab or the placebo on top of their regular insulin therapy throughout the study.

FABULINUS Trial Eligibility Criteria

Inclusion Criteria

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

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I have at least one type 1 diabetes autoantibody (GAD-65, IA-2, ZnT8, or Insulin).

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I am on insulin therapy for Type 1 Diabetes.

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I have been diagnosed with Type 1 Diabetes according to the American Diabetes Association.

FABULINUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52 and week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 52 and week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 and week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration

Secondary outcome measures

Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.)

Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants)

Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.)

+19 more

FABULINUS Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Frexalimab Dose 3Experimental Treatment2 Interventions

Group II: Frexalimab Dose 2Experimental Treatment2 Interventions

Group III: Frexalimab Dose 1Experimental Treatment2 Interventions

Group IV: PlaceboPlacebo Group2 Interventions

Matching Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin

2000

Completed Phase 4

~4280

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,788 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accepting participants beyond the age of 60?

"This research project has an age range of 12 to 35, meaning minors and young adults are eligible for partaking in the clinical trial."

Answered by AI

What deleterious effects may arise from Frexalimab Dose 1?

"Despite the lack of evidence that Frexalimab Dose 1 is effective, our team at Power rated its safety a 2 due to prior clinical data indicating limited risk."

Answered by AI

Is it possible to register for the experiment?

"This research trial is accepting 192 participants for type 1 diabetes, aged between 12 and 35."

Answered by AI

How many volunteers are actively participating in the experiment?

"Indeed, information posted to clinicaltrials.gov implies that this medical trial is currently recruiting patients. The study was launched on November 1st 2023 and underwent an update on October 31st of the same year. At present, it requires 192 individuals from a single site to complete enrollment."

Answered by AI

Are there still openings for this experiment?

"Affirmative. Clinicaltrials.gov data shows that this medical trial was posted on November 1st, 2023 and is actively seeking 192 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111586.

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