Designed to evaluate the safety and efficacy of ALX-0061, the trial is also aimed at obtaining parallel descriptive information concerning the efficacy and safety of administration of sc tocilizumab (Actemra, RoActemra) in the same RA population.
In September 2013, Ablynx and AbbVie entered into a global license agreement worth up to $840m to develop and commercialize ALX-0061.
Under that deal, Ablynx is responsible for Phase II clinical development of ALX-0061 in both RA and systemic lupus erythematosus (SLE).
The first Phase IIb trial with ALX-0061 in combination with MTX in patients with active RA was initiated in March 2015.
A total of 228 subjects in the US, Europe and South America will be enrolled in the current multi-centre, randomized Phase IIb trial, which includes two parallel treatment groups: a double-blind part to assess the efficacy and safety of ALX-0061 sc and an open-label part with tocilizumab sc.
Patients in the trial will be randomly assigned to three different dose groups of ALX-0061 sc or one dose group of tocilizumab sc every two weeks or every four weeks for 12 weeks.
The trial’s primary endpoint is the ACR20 response of ALX-0061 at week 12, while the secondary endpoints include higher level of response assessments of ALX-0061, documentation of efficacy of ALX-0061 over time, as well as the effects of ALX-0061 on the improvement in physical function and health-related quality of life.