At a glance
ClinicalIndex Comparison Record- ✓Meets criteria for Type 1 Diabetes Mellitus per American Diabetes Association
- ✓Initiated exogenous insulin within 90 days before screening
- ✓Receiving insulin therapy via MDI or CSII
- ✓Positive for at least 1 T1D autoantibody (GAD-65, IA-2, ZnT8, or insulin)
- ✕Serious systemic viral, bacterial or fungal infection within 30 days before/during screening
- ✕History of invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, PCP, aspergillosis)
- ✕Evidence of active or latent tuberculosis
- ✕Clinically significant, severe or unstable acute or chronic progressive uncontrolled infection or medical condition affecting safety
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
In the news
3 articles- STAT+: Pharmalittle: We’re reading about a broader $35 insulin cap, a former FDA cancer drug chief, and moreSTAT News·2026-06-29
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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.
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
In Brief
A Phase 2 clinical trial evaluating Frexalimab, Placebo, and 1 other intervention for Type 1 Diabetes Mellitus. Active but no longer recruiting, targeting 197 participants across 79 sites in 16 countries.
Signals
Detailed Summary
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. 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. If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.
Study Details
Timeline
Arms & Interventions
Matching Placebo
Interventions
IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
SC injection, dose and frequency will be established and/or adjusted by investigator