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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Sanofi
Study ID
NCT06812988
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Brivekimig — DRUG
    Pharmaceutical form: Solution Route of administration: Subcutaneous injection
  • Placebo — DRUG
    Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Mar 2026
Primary completion
Apr 29, 2027
Completion
Apr 29, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brivekimig
    Participants will receive subcutaneous injection of brivekimig.
  • Placebo Comparator: Placebo
    Participants will receive subcutaneous injection of matching placebo.

Primary Outcome Measure

Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration [ Time Frame: From Baseline to Week 26 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Atlanta Diabetes Associates- Site Number : 8400006AtlantaGeorgia30318-
IACT Health - Columbus - Talbotton Road- Site Number : 8400012ColumbusGeorgia31904-
Profound Research - MHP - TriAtria- Site Number : 8400015Farmington HillsMichigan48334-
Tekton Research - McKinney- Site Number : 8400017McKinneyTexas75069-
Advanced Research Institute - Odgen- Site Number : 8400007OgdenUtah84405-

Find similar trials in Atlanta, GA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Atlanta Diabetes Associates· Atlanta, GAIACT Health - Columbus - Talbotton Road· Columbus, GAProfound Research - MHP - TriAtria· Farmington Hills, MITekton Research - McKinney· McKinney, TXAdvanced Research Institute - Odgen· Ogden, UT

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