Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
Active, not recruiting · Phase 2 · NCT06812988
Conditions: Type 1 Diabetes Mellitus
At a glance
- Research payments reported, 2025
- $167,602
- U.S. investigators named
- 7
- Sites paid
- 6
- Planned or actual enrollment
- 84
About the trial
- Sponsor
- Sanofi
- Tested
- Brivekimig (drug), Placebo (drug)
- Dates
- Started 2025-02-28; completion 2027-04-29
- Results posted
- Not yet
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 perio…
From ClinicalTrials.gov, last updated 2026-03-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $167,602 in research payments for this study in 2025 (15 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Bruce W. Bode, M.D. Endocrinology & Diabetes · Atlanta, GA
- Steven B. Leichter, M.D. Endocrinology & Diabetes · Columbus, GA
- Ronak S. Chaudhari, M.D. Endocrinology & Diabetes · Bowling Green, KY
- Lowell R. Schmeltz, MD Endocrinology & Diabetes · Farmington Hills, MI
- Nicholas A. Avitabile, M.D. Endocrinology & Diabetes · Monroe, NY
- Pablo F. Mora, MD Endocrinology & Diabetes · Plano, TX
- Jack D. Wahlen, M.D. Endocrinology & Diabetes · Ogden, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Profound Research Llc $45,763
- Atlanta Diabetes Associates $29,500
- Empirican Prn Inc Circuit Clinical $28,400
- Cr Services Acquisition Us Llc Centricity Research $25,050
- Tekton Research Inc $23,689
- Advanced Research Inc $15,200
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.