The AP1189-CS002 study is a double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease.
The study is designed to test safety tolerability and efficacy of AP1189 vs Placebo given as add on treatment to methotrexate (MTX) in previous MTX naïve RA patients.
The study is set up in a part 1 where two doses of AP1189 is tested vs placebo in a total of 36 patients and in a part 2 where additional 54 patients is treated with AP1189 or Placebo in a 2:1 randomization.
The study is planned to complete dosing by the end of 2020 with reporting of key results during the spring of 2021
For further information on the study setup see clinicaltrials.gov: