Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (NCT06812988)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Atlanta Diabetes Associates- Site Number : 8400006 — Atlanta, Georgia
Age range: 12 Years to 35 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Atlanta Diabetes Associates- Site Number : 8400006 — Atlanta, Georgia
- IACT Health - Columbus - Talbotton Road- Site Number : 8400012 — Columbus, Georgia
- Profound Research - MHP - TriAtria- Site Number : 8400015 — Farmington Hills, Michigan
- Tekton Research - McKinney- Site Number : 8400017 — McKinney, Texas
- Advanced Research Institute - Odgen- Site Number : 8400007 — Ogden, Utah
- Investigational Site Number : 0320001 — Buenos Aires,
- Investigational Site Number : 0320002 — Buenos Aires,
- Investigational Site Number : 0320005 — Buenos Aires,
- Investigational Site Number : 0320004 — Buenos Aires,
- Investigational Site Number : 0320003 — Salta,
- Investigational Site Number : 0360003 — Saint Leonards, New South Wales
- Investigational Site Number : 0360002 — Brisbane, Queensland
- Investigational Site Number : 0360001 — Parkville, Victoria
- Centro de Diabetes Curitiba- Site Number : 0760005 — Curitiba, Paraná
- Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760002 — São Paulo,
- Investigational Site Number : 1240006 — Surrey, British Columbia
- Investigational Site Number : 1240001 — Vancouver, British Columbia
- Investigational Site Number : 1520004 — Concepción, Biobio
- Investigational Site Number : 1520003 — Providencia, Reg Metropolitana de Santiago
- Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago
- Investigational Site Number : 3760001 — Jerusalem,
- Investigational Site Number : 3760003 — Kefar Sava,
- Investigational Site Number : 3760002 — Ramat Gan,
- Investigational Site Number : 6820002 — Riyadh,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.