MIDORA trial demonstrates the efficacy and safety of dazodalibep in RA patients

A novel non-antibody biological CD40L antagonist named dazodalibep is currently under investigation as a potential therapy for autoimmune diseases. The results of the phase 2 MIDORA trial, published in the journal Rheumatic & Musculoskeletal Diseases (RMD) Open, reported the efficacy and safety of dazodalibep in patients with moderate-to-severe active rheumatoid arthritis (RA). 

Dr. Kivitz and colleagues conducted an evaluation of dazodalibep’s efficacy and safety in 78 patients with moderate-to-severe active RA. Eligible subjects were divided into five groups and randomly assigned to receive intravenous infusions of dazodalibep or a placebo. These subjects were followed until day 309. In comparison to the placebo group (-1.060.26), all dazodalibep groups exhibited significantly larger changes from baseline in the disease activity score in 28 joints calculated with C-reactive protein (DAS28-CRP) on day 113 (-1.830.28 to -1.900.27; p<0.05). Similar substantial reductions in DAS28-CRP were observed for all dazodalibep groups on day 309. The dazodalibep and placebo groups showed comparable distributions of adverse events (74% and 63% respectively), and four severe adverse events were determined to be unrelated to dazodalibep. 

A recent phase 2, randomized, double-blind study found that dazodalibep was safe and effective in treating disease activity and symptoms in 2 distinct populations of Sjögren’s syndrome (SS) patients. The study was presented at the 2023 EULAR European Congress of Rheumatology and published in the Annals of the Rheumatic Diseases. To know in detail, read our previous news Dazodalibep, a new promising novel therapeutic option for the management of Sjögren’s syndrome’. 

The current phase 2 trial highlights the potential of dazodalibep as a valuable therapeutic option for RA patients. The findings add to the growing body of evidence supporting the therapeutic potential of focusing on the CD40/CD40L pathway in the treatment of rheumatoid arthritis and other autoimmune diseases.  


  1. Kivitz A, Wang L, Alevizos I, Gunsior M, Falloon J, Illei G, et al. The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. RMD Open. 2023 Aug;9(3):e003317.  
  2. St EW, Clair, Wang L, Alevizos I, Rees W, Baer A, et al. Op0143 Efficacy and Safety of Dazodalibep (vib4920/Hzn4920) in Subjects with Sjögren’s Syndrome: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study. Annals of the Rheumatic Diseases. 2023 Jun 1;82(Suppl 1):95–95.