NCT02745145

Abituzumab in SSc-ILD

A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

Conditions

• Systemic Sclerosis-associated Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Abituzumab 1500 mg	Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
DRUG	Abituzumab 500 mg	Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
DRUG	Placebo	Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.

Timeline

• Start date: 2016-05-31
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2016-04-20
• Last updated: 2019-06-18
• Results posted: 2019-06-18

Locations

55 sites across 9 countries: United States, Argentina, Australia, Canada, Israel, Italy, Poland, Spain, United Kingdom