Brivekimig: Pharmaceutical form: Solution Route of administration: Subcutaneous injection
Placebo: Pharmaceutical form: Solution Route of administration: Subcutaneous injection
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Argentina | |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320003 | Salta | Argentina | |
| 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 | Brazil | |
| 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 | Israel | |
| Investigational Site Number : 3760003 | Kefar Sava | Israel | |
| Investigational Site Number : 3760002 | Ramat Gan | Israel | |
| Investigational Site Number : 6820002 | Riyadh | Saudi Arabia |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06812988 on ClinicalTrials.gov ↗ ← All trials in Israel