CD40 ligand antagonist dazodalibep in Sjogren's disease: a randomized, double-blinded, placebo-controlled, phase 2 trial.

ABSTRACT: Sjögren's disease (SjD) is a chronic, systemic autoimmune disease with no approved disease-modifying therapies. Dazodalibep (DAZ), a novel nonantibody fusion protein, is a CD40 ligand antagonist that blocks costimulatory signals between T and B cells and antigen-presenting cells, and therefore may suppress the wide spectrum of cellular and humoral responses that drive autoimmunity in SjD. This study was a phase 2, randomized, double-blinded, placebo (PBO)-controlled trial of DAZ with a crossover stage in two distinct populations of participants with SjD. Population 1 had moderate-to-severe systemic disease activity and population 2 had an unacceptable symptom burden and limited systemic organ involvement. All participants had a diagnosis of SjD, with 21.6% and 10.1% having an associated co

SUBMITTER: St Clair EW 

PROVIDER: S-EPMC11186761 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature