Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

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.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

197 actual participants took part.

It was open to people of any sex aged from 6 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants who meet the criteria of T1D according to American Diabetes Association. Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1). Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy. One or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or. Continuous subcutaneous insulin infusion (CSII).

The full record lists 14 inclusion and 19 exclusion criteria; among the exclusions: participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution; history or current hypogammaglobulinemia; systemic corticosteroids (duration \> 7 days), adrenocorticotropic hormone 1 month prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-12-11 with completion listed for 2027-04-28.

It ran at 79 sites in United States (14), Italy (8), Poland (7), Spain (7), United Kingdom (7) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.) (time frame: Baseline to Week 52). Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.) (time frame: Baseline to Week 26).

It also tracked 46 secondary outcomes, for example HbA1c level at Week 52 and Week 104(part B), Number of participants with at least one hypoglycemic event, Number of participants with at least one hyperglycemic episode, Number of participants with at least one diabetic ketoacidosis (DKA) event, Height and growth rate over time (for participants <18 y.o. at screening) and Frexalimab plasma concentrations over time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 197 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.