drugset / Trial / NCT01284569

Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients

NCT01284569

Phase 1/2 Completed 65 enrolled Ablynx, a Sanofi company
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2011-03
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Vobarilizumab Protein / enzyme biologic 0.3 mg/kg Intravenous
Subject Vobarilizumab Protein / enzyme biologic 1 mg/kg Intravenous
Subject Vobarilizumab Protein / enzyme biologic 3 mg/kg Intravenous
Subject Vobarilizumab Protein / enzyme biologic 6 mg/kg Intravenous
Subject Vobarilizumab Protein / enzyme biologic 8 mg/kg Intravenous

Indications