NCT02453256

A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.
DRUG	Tocilizumab	Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.

Timeline

• Start date: 2015-11-20
• Primary completion: 2018-01-15
• Completion: 2019-02-04
• First posted: 2015-05-25
• Last updated: 2020-03-09
• Results posted: 2019-04-03

Locations

83 sites across 22 countries: United States, Argentina, Belgium, Bulgaria, Canada, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study