Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGSC 20% · 1 trial · 1 indication
The rate of SBI events per participant per year during IGSC 20% treatment was calculated as the total number of SBI events divided by the total duration of exposure in years across all participants. The 2-sided 98% confidence interval (CI) was determined from a generalized linear model for poisson regression for the log-transformed number of events with log-transformed duration of exposure in years as an offset variable.
| Arm | Type | Description |
|---|---|---|
| IGSC 20% | EXPERIMENTAL | 13 doses of IGSC 20% in Treatment Stage 1 and 39 doses of IGSC 20% in Treatment Stage 2 for a total of 52 doses if IGSC 20% |
| Name | Type | Description |
|---|---|---|
| IGSC 20% | BIOLOGICAL | Weekly administration of IGSC 20% via intravenous infusion |
Inclusion Criteria: * Pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy * No serious bacterial infection within the 3 months prior to Screening and has no serious bacterial infections (SBIs) up to the time of the Baseline Visit * Currently on IgG ...
IGSC 20% is an investigational therapy being developed for the treatment of Primary Immunodeficiency. It is a monoclonal antibody product administered subcutaneously. The drug is currently in clinical development and has not been approved by regulatory authorities.
IGSC 20% is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is publicly traded under the ticker symbol GRFS. The company is conducting clinical trials to evaluate the efficacy and safety of IGSC 20% in patients with Primary Immunodeficiency.
IGSC 20% is in Phase 3 clinical development. A Phase 3 trial has been completed, which evaluated the efficacy, pharmacokinetics, safety, and tolerability of IGSC 20% in subjects with Primary Immunodeficiency. The drug remains investigational and is not yet approved.
IGSC 20% has been studied in one completed Phase 3 clinical trial with the identifier NCT02806986. This trial enrolled 61 participants with Primary Immunodeficiency and was conducted across multiple countries including Australia, Czechia, France, Germany, Hungary, Poland, Spain, Sweden, and the United Kingdom.
IGSC 20% is a specific formulation of subcutaneous immunoglobulin (IGSC) at a 20% concentration. It is being developed by Grifols for Primary Immunodeficiency. The drug is distinct in its concentration and route of administration compared to other immunoglobulin therapies.