NCT06812988

Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule

A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2a Study Assessing Safety and Efficacy of Brivekimig, a Dual Anti-TNF-α and Anti-OX40L NANOBODY® Molecule, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Recently Diagnosed Type 1 Diabetes

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy. The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo). The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.

Detailed description

The total study duration will be up to 83 weeks including Screening and Safety follow-up period.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Brivekimig	Pharmaceutical form: Solution Route of administration: Subcutaneous injection
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-04-29
• Completion: 2027-04-29
• First posted: 2025-02-06
• Last updated: 2026-03-13

Locations

24 sites across 8 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Israel, Saudi Arabia

Regulatory

• FDA-regulated drug study