Kiniksa Pharmaceuticals International, plc announced that it has commenced enrollment of the Phase 2b clinical trial of abiprubart in Sjögren?s Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction. Phase 2b Clinical Trial of Abiprubart in Sjögren?s Disease: The randomized, double-blind, placebo-controlled Phase 2b clinical trial is designed to evaluate the treatment response of chronic subcutaneous (SC) administration of abiprubart in patients with Sjögren?s Disease.

The placebo-controlled portion of the trial will randomize approximately 201 patients in a 1:1:1 ratio to receive abiprubart 400 mg SC biweekly, 400 mg SC monthly, or placebo over a period of 24 weeks. The primary endpoint is change from baseline in EULAR Sjögren?s Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24. Subsequently, patients will enter a long-term extension in which active treatment will be given in all study arms for an additional 24 weeks.