Trials / Withdrawn
WithdrawnNCT04138485
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IgPro10 | 10% liquid formulation of human immunoglobulin for IVIG |
| BIOLOGICAL | Placebo | 0.5% human albumin solution stabilized with 250 mmol/L L-proline |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2020-09-16
- Completion
- 2020-09-16
- First posted
- 2019-10-24
- Last updated
- 2020-11-17
Locations
77 sites across 13 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy, Mexico, Poland, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04138485. Inclusion in this directory is not an endorsement.