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Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Diffuse Cutaneous Systemic Sclerosis Clinical Trial

Official title:
A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis

Clinical Trial Summary

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04138485
Study type Interventional
Source CSL Behring
Contact
Status Withdrawn
Phase Phase 2
Start date December 20, 2019
Completion date September 16, 2020
View Details
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