Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS) (NCT06111586)
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 Ξ²-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
π©Ί Plain-English Summary (8th-Grade Level)
This is a randomized, parallel group, double-blind Phase 2 study with a 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. Enrollment date of the participant must take into consideration this constraint) Double-blind treatment period (104 weeks for Part A and Part B; 52 weeks for Part C): Main treatment period: 52 weeks for Parts A and B, 26 weeks for Part C Blinded extension: 52 weeks (for Part A and Part B, 26 weeks for Part C) Optional OLE period: 104 weeks for all parts Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks for Part A and Part B or 52 weeks for Part C, the total study duration will be up to 135 weeks for Part A and Part B or 83 weeks for Part C. If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco - Mission Bay- Site Number : 8400012 β San Francisco, California
Age range: 6 Years to 35 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (79 Sites)
Showing the first 25 of 79 sites.
- University of California San Francisco - Mission Bay- Site Number : 8400012 β San Francisco, California
- University of Colorado - Anschutz Medical Campus- Site Number : 8400003 β Aurora, Colorado
- University of Florida College of Medicine- Site Number : 8400010 β Gainesville, Florida
- University of Miami Hospital- Site Number : 8400013 β Miami, Florida
- AdventHealth Orlando- Site Number : 8400002 β Orlando, Florida
- Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009 β Idaho Falls, Idaho
- NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007 β Skokie, Illinois
- Joslin Diabetes Center - Boston- Site Number : 8400015 β Boston, Massachusetts
- University at Buffalo - Downtown Campus- Site Number : 8400004 β Buffalo, New York
- University of North Carolina at Chapel Hill- Site Number : 8400001 β Chapel Hill, North Carolina
- Cincinnati Children's Hospital Medical Center- Site Number : 8400019 β Cincinnati, Ohio
- The Children's Hospital of Philadelphia Site Number : 8400005 β Philadelphia, Pennsylvania
- University of Texas - Southwestern Medical Center- Site Number : 8400011 β Dallas, Texas
- Benaroya Research Institute at Virginia Mason- Site Number : 8400016 β Seattle, Washington
- Investigational Site Number : 0400002 β Graz,
- Investigational Site Number : 0400004 β Linz,
- Investigational Site Number : 0400001 β Vienna,
- Investigational Site Number : 0560002 β Brussels,
- Investigational Site Number : 0560001 β Leuven,
- Investigational Site Number : 1240001 β Vancouver, British Columbia
- Investigational Site Number : 1240007 β London, Ontario
- Investigational Site Number : 1240005 β Montreal, Quebec
- Investigational Site Number : 1240004 β Montreal, Quebec
- Investigational Site Number : 1240003 β Montreal, Quebec
- Investigational Site Number : 2030003 β Ostrava,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.