drugset / Trial / NCT04138485

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

NCT04138485

Phase 2 Withdrawn CSL Behring
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-12-20
Primary completion
2020-09-16
Completion
2020-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic Intravenous