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NCT06111586 · ClinicalTrials.gov registry record · Phase 2
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT06111586: Recruiting Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
NCT06111586 is a Phase 2 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by Sanofi. The registered enrollment target is 192 participants, above the 170-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06111586, a Phase 2 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC
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
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2030-10-29 |
| Phase | Phase 2 |
What NCT06111586 shows while recruiting
NCT06111586 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 170-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (13% higher).
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.
NCT06111586 names 20 study sites across 14 states, led by Other, Florida, California.
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.
What interventions are being tested in trial NCT06111586?
The interventions under investigation include: Placebo (DRUG), Insulin (DRUG), Frexalimab (DRUG).
Who is sponsoring clinical trial NCT06111586?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06111586's enrollment target sits among peer trials
192 19th of 112 higher than 94 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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