NCT01751776

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI 655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after 12 weeks of treatment

Conditions

• Arthritis, Rheumatoid
• Healthy

Interventions

Type	Name	Description
DRUG	Placebo matching BI 655064	Placebo matching BI 655064 injected subcutaneous.
DRUG	BI 655064	BI 655064 injected subcutaneous

Timeline

• Start date: 2012-12-18
• Primary completion: 2015-03-02
• Completion: 2015-04-27
• First posted: 2012-12-18
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

25 sites across 6 countries: Czechia, Germany, Netherlands, New Zealand, Poland, Spain