NCT02430909

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: UCB Celltech · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Bimekizumab	* Pharmaceutical form: Solution for infusion * Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose * Route of administration: iv infustion
BIOLOGICAL	Certolizumab Pegol	* Pharmaceutical form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
OTHER	Placebo	* Pharmaceutical form: Solution for infusion * Concentration: 0.9% saline * Route of administration: Intravenous infusion

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-04-30
• Last updated: 2017-05-31

Locations

21 sites across 7 countries: Czechia, Hungary, Moldova, Poland, Russia, Slovakia, United Kingdom