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RECRUITING Phase 2

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

NCT06111586 · View on ClinicalTrials.gov ↗

Study Summary

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. Study details include: Screening period: at least 3 weeks and up to 5 weeks Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Insulin
  • DRUG Frexalimab

Study Locations (20)

Other

  • Investigational Site Number : 0400002 — Graz
  • Investigational Site Number : 0400004 — Linz
  • Investigational Site Number : 0400001 — Vienna
  • Investigational Site Number : 0560002 — Brussels
  • Investigational Site Number : 0560001 — Leuven

Florida

  • University of Florida College of Medicine- Site Number : 8400010 — Gainesville
  • University of Miami Hospital- Site Number : 8400013 — Miami
  • AdventHealth Orlando- Site Number : 8400002 — Orlando

California

  • University of California San Francisco - Mission Bay- Site Number : 8400012 — San Francisco

Colorado

  • University of Colorado - Anschutz Medical Campus- Site Number : 8400003 — Aurora

Idaho

  • Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009 — Idaho Falls

Illinois

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007 — Skokie

Massachusetts

  • Joslin Diabetes Center - Boston- Site Number : 8400015 — Boston

New York

  • University at Buffalo - Downtown Campus- Site Number : 8400004 — Buffalo

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2023-12-11
Est. Completion 2030-10-29
Phase Phase 2

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06111586

The ClinicalTrials.gov registry entry for NCT06111586 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06111586 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06111586 about?

NCT06111586 is a clinical study titled "FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)". 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. Study details include: Screening period: at ...

What is the current status of trial NCT06111586?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2023-12-11. Estimated completion is 2030-10-29.

What conditions does trial NCT06111586 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06111586?

The interventions under investigation include: Placebo (DRUG), Insulin (DRUG), Frexalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06111586?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06111586 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial