Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor
Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and
efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.
This is a 28-week (up to 4-week screening period, 12-week treatment period, and 12-week
safety follow-up period), multicenter, randomized, double-blind, placebo-controlled, multiple
dose, proof-of-concept study with PK lead-in designed to assess the safety, PK, efficacy and
PD of KPL-404 in subjects with moderate to severe, active Rheumatoid Arthritis (RA) who have
an inadequate response to or are intolerant to a Janus kinase inhibitor (JAKi) AND/OR at
least one biologic disease-modifying anti-rheumatic drug (bDMARD). The objectives of the
study are to evaluate safety, efficacy, and PD of KPL-404 compared with placebo across the
estimated therapeutic range and to characterize PK across varying dose levels of KPL-404.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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