ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and is being developed to treat rheumatoid arthritis (RA) and SLE. The trial is designed to identify the optimum dose and frequency of administration of ALX-0061 for the next development phases.
Earlier in September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to $840m plus double-digit royalties, to develop and commercialise ALX-0061.
Under that deal, Ablynx is responsible for Phase II clinical development of ALX-0061 in rheumatoid arthritis and systemic lupus erythematosus.
Ablynx CEO Dr Edwin Moses said: "Ablynx and our partner AbbVie are committed to making ALX-0061 available for patients suffering from debilitating inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus.
"The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018.
"If the results meet the pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent development and commercialisation."
Around 300 subjects in the US, Europe, South America and Asia will be enrolled in this multi-centre, randomized, double-blind, placebo-controlled, dose-range finding Phase II study in SLE.
In the trial, patients will be randomly assigned to placebo or one of the four different dose groups of ALX-0061, while they will be followed for efficacy up to and including week 48 and for safety up to and including week 58.