ArticleDiabetes, obesity & metabolism2026
A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design.
Article in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial 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 β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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 β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
Who cites it
1 citing paper in PubMed.
- A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design.Diabetes, obesity & metabolism · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
introductionType 1 diabetes (T1D) is a chronic autoimmune disease, characterised by progressive destruction of the insulin-producing pancreatic β-cells. Preserving remaining β-cells at the time of diagnosis may improve long-term outcomes. Frexalimab is a humanised monoclonal antibody specific for CD40L undergoing evaluation for treatment of various immune-mediated conditions. METHODS AND ANALYSIS: This is a double-blind, Phase 2 trial to assess the efficacy and safety of frexalimab for preservation of pancreatic β-cell function in adolescents and young adults (12-35 years) with recently diagnosed Stage 3 T1D on insulin therapy. Participants who meet all inclusion criteria will be randomly assigned to receive frexalimab or a matching placebo in a 2:1 ratio in all cohorts for 104 weeks. A total of 192 participants will be recruited sequentially into two parts. Part A (n = 30) is exploratory and designed to establish the safety of the highest dose of frexalimab compared with placebo in adults (18-35 years). In Part B, 162 adolescents and young adults (12-21 years) are randomised sequentially to three age-adjusted dose-levels of frexalimab or placebo. The primary endpoint is the change from baseline to 52 weeks in mean 2-h mixed meal tolerance test stimulated C-peptide concentration, calculated from the area under the curve. Secondary endpoints include time in range by intermittent continuous glucose monitoring measures, glycated haemoglobin (HbA1c), daily insulin dose, number of hypoglycaemic events and insulin dose adjusted HbA1c measurements. ETHICS AND DISSEMINATION: This trial received ethical approval in October 2023 and began screening in December 2023 with first participant randomised in January 2024. The results will be submitted to a peer-reviewed medical journal and presented at conferences.
trial registrationEU trial number: 2022-500531-36-00 and ClinicalTrials.gov: NCT06111586.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.