The safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of ALX-0061 was assessed in a Phase I/II study in patients (pts) with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy (1). Objectives Since remission is the recommended treatment target in the ...
Methods Multicentre, randomised, double-blind, placebo controlled, dose escalation, Phase I/II study in patients with active RA on stable MTX therapy. MAD: In the first 12 weeks patients received placebo or ALX-0061 IV infusion at 1 or 3 mg/kg Q4W, or 6 mg/kg Q8W. In the second ...
Two Phase IIb studies with ALX-0061 initiated
Preferential inhibition of sIL-6R trans-signalling by ALX-0061 could provide superior therapeutic efficacy with a better side effect profile than TCZ. ALX-0061 is currently in clinical development. Analysis of a phase I/II study demonstrated a strong efficacy and an attractive safety profile. ...