This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.
Placebo administered corresponding to NNC0215-0384 treatment
Unnamed facility
Berlin, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Krakow, Poland
Unnamed facility
Moscow, Russia
Incidence of adverse events (AEs)
Time frame: From first dosing until 19 weeks after first dosing
Concentration of NNC0215-0384 in serum
Time frame: 7 days after each dose
Concentration of NNC0215-0384 in serum
Time frame: 3 days after first and last dose
Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline
Time frame: From week 0 until 19 weeks after first dosing
Change in health assessment questionnaire - disability index (HAQ-DI) from baseline
Time frame: Week 0, week 7 first dosing
Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity
Time frame: From first dosing until 19 weeks after first dosing
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