A Phase 2 (2a) Randomized Trial of Iscalimab in Adolescents and Young Adults with New-Onset Type 1 Diabetes
Primary result · C-peptide AUC during mixed meal tolerance testResult — go to the resultRatio 1.173 80% one-sided CI 0.94–1.47- Treatment discontinued prematurely in seven, two of these due to a temporary trial halt during the COVID-19 pandemic
Authors' conclusion
Iscalimab has an acceptable safety and tolerability profile. The sample size limits interpretation of efficacy results. CD40:CD154 inhibition warrants further investigation in T1DM.
Study context
- Population
- Adolescents and young adults with new-onset stage 3 T1D, 14 centers in 6 countries; mean age 16 years (range 12–21)39 completed
- Participants
- 44 adolescents
- Comparison
- Iscalimab vs placebo
- Primary endpoint
- C-peptide AUC during mixed meal tolerance test
- Follow-up
- 52 weeks
Methodological detailsphase 2 (2a), placebo-controlled, multicentre, 14 centers in 6 countries
- Phase 2 (2a)
- Placebo-controlled
- Multicentre
- 14 centers in 6 countries
Primary result
As reported in the abstract
Ratio
1.173
80% one-sided CI 0.94–1.47
P(one-sided) = 0.18
Further findings
| Outcome | Iscalimab | Placebo | P value |
|---|---|---|---|
| Yearly rate of change of normalized stimulated C-peptide AUC | −0.14 (80% one-sided one-sided CI −0.23–-0.05) nmol/L per year | −0.33 (80% one-sided one-sided CI −0.42–-0.23) nmol/L per year | P(one-sided) = 0.04 |
| Geometric mean ratio to baseline of HbA1c · week 52Estimated geometric mean ratio | 0.95 (80% CI 0.92–0.99) | 1.05 (80% CI 1.00–1.11) |
Blood cell counts
- Leukocytes, neutrophils and monocytes lower, T and B lymphocytes higher with iscalimab vs placebo
Safety
Events
| Outcome | Iscalimab | Placebo |
|---|---|---|
| Serious AEs | 5 | 1 |
- Serious adverse events (AEs) — Iscalimab: urinary tract infection, diabetic metabolic decompensation, traumatic fracture, hypoglycemia, large intestine infection
- 3.4% each
- Serious AEs — Placebo: mastoiditis
- 6.7%
Serious AEs
- Most common AEs: hypoglycemia, nasopharyngitis, injection site reaction, COVID-19, neutropenia; majority mild-to-moderate and resolved
Original publication
A Phase 2 (2a) Randomized Trial of Iscalimab in Adolescents and Young Adults with New-Onset Type 1 Diabetes. Diabetes Technol Ther. Published 20 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →