Trials / Recruiting
RecruitingNCT06111586
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension and an Optional Open-label Extension - Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years – 35 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Frexalimab | Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102 |
| DRUG | Placebo | IV Infusion at Day 1 and SC Injection from W2 to W102 |
| DRUG | Insulin | SC injection, dose and frequency will be established and/or adjusted by investigator |
Timeline
- Start date
- 2023-12-11
- Primary completion
- 2027-04-28
- Completion
- 2030-10-29
- First posted
- 2023-11-01
- Last updated
- 2026-04-08
Locations
80 sites across 16 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06111586. Inclusion in this directory is not an endorsement.