The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Intravenous administration, single dose (0.3-1-3-6-8 mg/kg) or multiple dose (Biologically effective dose, once every 4 weeks or once every 8 weeks, for 24 weeks)
Intravenous administration, single dose or multiple dose (once every 4 weeks or once every 8 weeks, for 12(/24) weeks; switch to ALX-0061 in weeks 13-24 if no response after first 12 weeks)
Unnamed facility
Prague, Czechia
Unnamed facility
Třinec, Czechia
Unnamed facility
Budapest, Hungary
Unnamed facility
Szeged, Hungary
Unnamed facility
Krakow, Poland
Safety: number of treatment emergent adverse events (TEAEs)
Time frame: From first study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
Pharmacokinetics (PK): serum concentration of ALX-0061
Time frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
Biological efficacy: pharmacodynamic (PD) markers
C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), fibrinogen, interleukin 6 (IL6), soluble IL6 receptor (sIL6R), tumour necrosis factor alpha (TNFalpha), interleukin 1 beta (IL1beta), interferon gamma (IFNgamma)
Time frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
Disease activity: RA-related assessments
ACR response, DAS28 score, EULAR response
Time frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Warsaw, Poland
Unnamed facility
Wroclaw, Poland