Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IVIG · 2 trials · 3 indications
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
The subjects also evaluated their skin-specific quality of life with the Skindex-29 - the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
| Arm | Type | Description |
|---|---|---|
| First IVIG, then Placebo | EXPERIMENTAL | Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. |
| First Placebo, then IVIG | EXPERIMENTAL | Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks. |
| IVIg as a monotherapy | ACTIVE_COMPARATOR | IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy. |
| Name | Type | Description |
|---|---|---|
| IVIG | DRUG | 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks |
| Placebo | OTHER | 0.1% Albumin in an equal volume to the investigational product |
Inclusion Criteria: * Lung transplant recipients \> 3 months after transplant surgery * Immunoglobulin G (IgG) \< 500 mg/dL * Stable medical regimen Exclusion Criteria: * Acute rejection * Active infection * Contraindication to IVIG * Pregnancy * Recent thrombotic event
IVIG is used for hypogammaglobulinemia and cutaneous lupus erythematosus. It is an investigational therapy being studied in clinical trials for these conditions. IVIG is being developed by Grifols, S.A. (GRFS) and is currently in Phase 2 clinical development.
IVIG is a small molecule immunology therapy. Its specific molecular target has not been disclosed. It is being studied for its effects on immune-related conditions, including hypogammaglobulinemia and cutaneous lupus erythematosus.
IVIG is being developed by Grifols, S.A., a biopharmaceutical company traded on the stock exchange under the ticker GRFS. The company is conducting clinical trials to evaluate IVIG for the treatment of hypogammaglobulinemia and cutaneous lupus erythematosus.
IVIG is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for the treatment of hypogammaglobulinemia and cutaneous lupus erythematosus.
IVIG has been studied in clinical trials including NCT00115778, which evaluated intravenous immunoglobulin in lung transplantation for hypogammaglobulinemia, and NCT01841619, which assessed IVIg efficacy in cutaneous lupus erythematosus. Both trials have been completed.
IVIG is the abbreviation for intravenous immunoglobulin. It is a therapy being developed by Grifols, S.A. for conditions such as hypogammaglobulinemia and cutaneous lupus erythematosus. The drug is currently in Phase 2 clinical development.