drugset / Trial / NCT04138485
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |