Active Diabetes, Hormones & Metabolism NIHR-supported project Digestion, Kidneys & Other Organs

A 52-week randomized, double-blind, placebocontrolled, multi-center dose-finding study with a 52 week blinded extension assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, for preservation of pancreatic ?-cell function in children, adolescents and young adults (age range 6-21 years old) with newly diagnosed type 1 diabetes (T1D) on insulin therapy

Funder NIHR (part of DHSC)
Recipient organisation NIHR Cambridge Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Nov 2028

In plain English

AI plain-English summary

A new clinical trial is testing whether an injected antibody can preserve the insulin-producing cells that are destroyed in type 1 diabetes. Type 1 diabetes forces patients to manage their blood sugar with insulin injections for life, because their immune system attacks the beta cells in the pancreas. This study, called Fabulinus, tests a drug called frexalimab that blocks a protein called CD40L, which is involved in that immune attack. The trial recruits children, adolescents, and young adults aged 6 to 21 who were diagnosed with type 1 diabetes within the past three months, when some beta cells may still remain. Participants receive either frexalimab or a placebo by injection for two years, alongside their usual insulin. Neither they nor their doctors know which treatment they receive. If frexalimab works, it could slow or stop the destruction of beta cells, allowing patients to produce some of their own insulin for longer. That would mean fewer daily insulin injections, better blood sugar control, and a lower risk of long-term complications such as kidney damage, blindness, and nerve problems. The trial is double-blinded and placebo-controlled, running across 13 countries, to ensure any benefit is real and not due to wishful thinking.

View original technical description
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.

Researchers

Loredana Marcovecchio (Principal Investigator)

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Original classification

Antenatal, Maternal and Child Health

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.