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Also known as Gamunex-C, 10% Injectable Solution, Gamunex-C, 10% Injectable
Gamunex-C · 3 trials · 3 indications
AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
| Arm | Type | Description |
|---|---|---|
| Gamunex-C (IGIV-C 10%) | EXPERIMENTAL | During the IV Phase, participants will receive Gamunex-C 1 g/kg, up to a maximum dose of 90 g, every 3 weeks for a total of seven doses. Gamunex-C may be administered over 1 day or divided into 2 consecutive daily doses of 0.5 g/kg each, except for dose #6, which will be administered as a single 1g/kg dose. |
| Xembify (IGSC 20%) | EXPERIMENTAL | Approximately 7 to 10 days after the last Gamunex-C dose, participants will enter a 16-week SC Phase, where they will receive XEMBIFY 0.456 g/kg once weekly for a total of 16 doses, up to a maximum dose of 41 g. |
| Gamunex-C | ACTIVE_COMPARATOR | Participants received Gamunex-C by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. Gamunex-C was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of Gamunex-C treatment included the Gamunex-C PK Phase (up to 4 weeks) plus the additional Gamunex-C Run-in Phase (up to 4.5 months) for participants not receiving Gamunex-C or not on a stable dose of Gamunex-C upon entering the trial. The approximate maximum duration was up to 6 months. |
| IVIG-PEG | EXPERIMENTAL | Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months. |
| GAMUNEX-C + Standard Medical Treatment | EXPERIMENTAL | Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29. |
| Standard Medical Treatment | ACTIVE_COMPARATOR | Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29. |
| Name | Type | Description |
|---|---|---|
| Gamunex-C | BIOLOGICAL | Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%) |
| Xembify | BIOLOGICAL | Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) |
| IVIG-PEG | BIOLOGICAL | Intravenous infusion. |
| Standard Medical Treatment | DRUG | SMT per local policies or guidelines. |
Inclusion Criteria: * Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP. * Participants ≤ 90 kg in body weight and requiring an IGIV d...
GAMUNEX-C is an investigational immune globulin product being studied for use in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), chronic lymphocytic leukemia, multiple myeloma, non-Hodgkin lymphoma, primary immunodeficiency, and COVID-19. It is a monoclonal antibody product developed by Grifols, S.A. (NASDAQ: GRFS).
GAMUNEX-C is a monoclonal antibody product. It is a form of immune globulin that provides passive immunity by delivering antibodies to patients. The specific molecular target has not been disclosed in the available information.
GAMUNEX-C is developed by Grifols, S.A., a biopharmaceutical company traded on NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the product's safety and efficacy across several indications.
GAMUNEX-C is in Phase 2 clinical development for COVID-19, with one completed Phase 2 trial. It is also being studied in Phase 3 trials for primary immunodeficiency, CIDP, and hematologic malignancies. It is investigational and not yet approved by the FDA.
GAMUNEX-C has been studied in several trials. NCT04480424 is a completed Phase 2 trial in COVID-19. NCT04561115 is a completed Phase 3 trial in primary immunodeficiency. NCT07540221 is a recruiting Phase 3 trial in CIDP. NCT07582432 is a recruiting Phase 3 trial in chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin lymphoma.
Yes, GAMUNEX-C is also known as Gamunex-C, 10% Injectable Solution. The product is referred to by these alternative names in clinical trial documentation and regulatory filings.