The goal of this study is to see how the experimental study drug, VIB4920 (dazodalibep), affects control of rheumatoid arthritis (RA).

About Study Drug

VIB4920 is a bioengineered protein that works by blocking certain cells of the immune system from attacking one’s own body, including joints. This may result in your RA becoming less active or even inactive. In an early phase trial, VIB4920 was found to be safe, tolerable, and effective in reducing joint pain and swelling in patients with rheumatoid arthritis. VIB4920 is currently being studied in other trials. VIB4920 is considered an experimental treatment because it has not been approved for use in RA or other diseases at this time.

*A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis (NCT02780388), results published in Science Translational Medicine. 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 (NCT04163991). Results published in RMD Open.

Participating in the CONTROL-RA Study

There are three treatment groups in this study. Eligible participants will be randomly assigned to receive one of the following:

  • The study drug, VIB4920, added to their current treatment with etanercept (Enbrel®), adalimumab (Humira®) or their respective biosimilars
  • A placebo, which is an inactive substance made to look like the study drug, added to their current treatment with etanercept, adalimumab or their respective biosimilars
  • The study the study drug, VIB4920, and stopping their current treatment with etanercept, adalimumab or their respective biosimilars

You cannot choose your group. A computer randomly picks who will be in each group.

CONTROL-RA is a 40-week research study

Treatment Period 3 months (12 weeks)
  • 6 clinic visits (weeks 0, 2, 4, 8, and 12) where the participant receives an IV infusion of the study drug
  • 2 telephone visits (weeks 6 and 10)
Follow-up Period 7 months (28 weeks)
  • 7 clinic visits (every 4 weeks)
  • 1 telephone visit (week 14)

Your participation may also involve weekly self-assessments and other procedures that you can complete at home.

Learn whether you might be eligible for CONTROL-RA.