FABULINUS
Research type
Research Study
Full title
A 52-week randomized, double-blind, placebo controlled, multi-center Phase 2b study with a 52-week blinded 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
IRAS ID
1008407
Contact name
Johannes Juhnke
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
This Fabulinus study is a double-blinded, placebo-controlled study that will take place in 13 countries, where each person will have treatment for 2 years, and then followed up for 6 months or will be offered to further prolong the treatment. The study compares how effective and safe the medicine is compared to a placebo, in addition to the insulin treatment. A placebo looks like the medicine being tested, but it does not have any real medicine in it (dummy treatment). “Double-blinded” means that neither the people participating, nor the study doctors know who is given the study medicine or the placebo. This is done to make sure that the study results are not influenced in any way. The study has 2 phases: Part A: adults (18-35 years old) take frexalimab Dose 3 or placebo for 2 years. Part B: adolescents and young adults (12-21 years old) take one of 3 frexalimab doses (Dose 1, 2 or 3) or a placebo for 2 years. Study medicine Frexalimab, is being developed as a possible treatment for various auto-immune diseases. It works by blocking a protein in the body called CD40L, involved in immune response. The treatment (frexalimab/ placebo) is randomly chosen (ie, selected by chance using a computer program) for each participant and given by injection. Frexalimab was well tolerated by people participating in other clinical studies. The benefits are not known at this time. This study wants to test whether it can help people with Type 1 diabetes. A placebo is used to better see the effect of the study medicine. All the participants take insulin treatment in addition to frexalimab or placebo.
People 12 to 35 YoA recently diagnosed with T1D and receiving insulin treatment for no longer than 3 months before participation in the study. People with certain current medical problems and medications, or medical history, that makes them unsuitable for the study.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0273
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion