Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
Public ClinicalTrials.gov record NCT06111586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
Study identification
- NCT ID
- NCT06111586
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 197 participants
Conditions and interventions
Conditions
Interventions
- Frexalimab Drug
- Placebo Drug
- Insulin Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 35 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 10, 2023
- Primary completion
- Apr 27, 2027
- Completion
- Oct 28, 2030
- Last update posted
- Jun 28, 2026
2023 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco - Mission Bay- Site Number : 8400012 | San Francisco | California | 94158 | — |
| University of Colorado - Anschutz Medical Campus- Site Number : 8400003 | Aurora | Colorado | 80045 | — |
| University of Florida College of Medicine- Site Number : 8400010 | Gainesville | Florida | 32610 | — |
| University of Miami Hospital- Site Number : 8400013 | Miami | Florida | 33136 | — |
| AdventHealth Orlando- Site Number : 8400002 | Orlando | Florida | 32803 | — |
| Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009 | Idaho Falls | Idaho | 83404 | — |
| NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007 | Skokie | Illinois | 60077 | — |
| Joslin Diabetes Center - Boston- Site Number : 8400015 | Boston | Massachusetts | 02215 | — |
| University at Buffalo - Downtown Campus- Site Number : 8400004 | Buffalo | New York | 14203 | — |
| University of North Carolina at Chapel Hill- Site Number : 8400001 | Chapel Hill | North Carolina | 27514 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400019 | Cincinnati | Ohio | 45229 | — |
| The Children's Hospital of Philadelphia Site Number : 8400005 | Philadelphia | Pennsylvania | 19104 | — |
| University of Texas - Southwestern Medical Center- Site Number : 8400011 | Dallas | Texas | 75390 | — |
| Benaroya Research Institute at Virginia Mason- Site Number : 8400016 | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06111586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06111586 live on ClinicalTrials.gov.