This phase 2 trial will evaluate the effects of ABBV-105, taken alone or in combination with upadacitinib for the treatment of rheumatoid arthritis (RA). The main outcome to be measured will be an improvement in disease activity.
The details
Rheumatoid arthritis (RA) is a condition caused by excessive inflammation. Patients experience pain and stiffness in their joints. To treat RA, patients are prescribed medication to reduce inflammation. Many patients require several different drugs to manage RA.
Disease-modifying anti-rheumatic drugs (DMARDs) are used to treat RA. Some patients do not respond well to conventional synthetic (cs)DMARDs. Some new RA drugs target certain enzymes involved in inflammation. Upacitiniib (UCB) is an example of an RA drug that blocks a Janus Kinase (JAK) enzyme. ABBV-105 is an experimental drug for the treatment of RA. It works by blocking an enzyme called Bruton’s tyrosine kinase (BTK). Blocking BTK prevents the activation of receptors involved in inflammation.
This trial will evaluate the effects of ABBV-105, taken alone or in combination with UCB for the treatment of rheumatoid arthritis (RA). The main outcome will be an improvement in disease activity over 12 weeks.
Who are they looking for?
This trial will recruit 240 patients with RA. Patients must be on a stable regimen of csDMARDs and cannot be taking biological DMARDs at the time of the study.
Patients that have previously taken JAK inhibitors cannot take part in the trial.
How will it work
Participants will be randomly assigned into one of 6 groups. Some participants will receive different doses of ABBV-105 with or without UCB. Some patients will receive placebo (inactive tablet) instead of either ABBV-105 or UCB. The trial will last 12 weeks. Disease activity will be measured using the Disease Activity Score 28 (DAS28) and c-reactive protein (CRP; a blood marker of inflammation).
The main outcome to be evaluated will be a change in DAS28-CRP at 12 weeks.
