Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Immune Globulin Intravenous (Human), 10%, Immune Globulin, 10%, Immune Globulin Intravenous (Human), 10% Solution, Immune Globulin, 10% Triple Virally Reduced, Immune Globulin Subcutaneous (Human), 20%, Immune Globulin, 20%, Immune Globulin Intravenous (IGIV), Immune Globulin
Immune Globulin, 10% TVR · 9 trials · 7 indications
Total serum trough levels of IgG antibodies measured during period 2 of Epoch 2 were assessed.
Total serum trough levels of IgG antibodies measured during Epoch 3 were assessed.
The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.
The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Relative Change is defined as 100 \* (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections
Expressed as (AUC\_SC/AUC\_IV) \* 100
Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.
| Arm | Type | Description |
|---|---|---|
| Epoch 1: IGIV 200-600 mg/kg | EXPERIMENTAL | Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 3 or 4 weeks for up to 13 weeks. |
| Epoch 2: IGSC (20%) 50-200 mg/kg | EXPERIMENTAL | Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1. |
| Epoch 3: IGSC (20%) 100-400 mg/kg | EXPERIMENTAL | Participants who entered to Epoch 3 from Epoch 1 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to approximately 12 weeks after Epoch 2. |
| IGIV, 10% 400mg/kg | EXPERIMENTAL | Immune Globulin Intravenous (Human), 10% (IGIV, 10%) |
| IGIV, 10% 200mg/kg | EXPERIMENTAL | Immune Globulin Intravenous (Human), 10% (IGIV, 10%) |
| Human Albumin 0.25% Solution - 4 mL/kg | PLACEBO_COMPARATOR | 0.25% human albumin solution infused at 4 mL/kg/2weeks |
| Human Albumin 0.25% Solution - 2 mL/kg | PLACEBO_COMPARATOR | 0.25% human albumin solution infused at 2 mL/kg/2weeks |
| IGIV, 10% Then Placebo | EXPERIMENTAL | STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: IGIV, 10% (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg body weight (BW) per infusion cycle). |
| Placebo Then IGIV, 10% | EXPERIMENTAL | STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human) (Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: IGIV, 10% (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle) |
| Study Epochs 1-4 | EXPERIMENTAL | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
| Epoch 1 (intravenous pre-study treatment) + Epoch 2 | EXPERIMENTAL | Study Epoch 1 (13 weeks): treatment with KIOVIG (once every 3 or 4 weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents) |
| Epoch 1 (subcutaneous pre-study treatment) + Epoch 2 | EXPERIMENTAL | Study Epoch 1 (12 weeks): treatment with SUBCUVIA (once every week or once every two weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents) |
| Name | Type | Description |
|---|---|---|
| Immune Globulin Intravenous (IGIV) | BIOLOGICAL | Participants will receive IGIV infusion. |
| Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%) | BIOLOGICAL | Participants will receive IGSC, 20% SC infusion. |
| Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg | BIOLOGICAL | 400 mg/kg bodyweight every 2 weeks for 70 weeks |
| Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg | BIOLOGICAL | 200 mg/kg bodyweight every 2 weeks for 70 weeks |
| Placebo solution: Human Albumin 0.25% - 4 mL/kg | BIOLOGICAL | Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks |
| Placebo solution: Human Albumin 0.25% - 2 mL/kg | BIOLOGICAL | Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks |
| Immune Globulin Intravenous (human), 10% | BIOLOGICAL | Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific) |
| 0.25% human albumin solution (Placebo) | BIOLOGICAL | Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1 |
| Immune Globulin Intravenous (Human), 10% Solution | BIOLOGICAL | Intravenous infusion with IGIV, 10% |
| Immune Globulin Subcutaneous (Human), 20% Solution | DRUG | Subcutaneous infusion with IGSC, 20% |
| Immune Globulin Subcutaneous (Human), 20% | BIOLOGICAL | Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects) |
| Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin) | BIOLOGICAL | Subcutaneous infusion (regulated via a pump) |
| Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution | DRUG | - |
| Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution | DRUG | - |
| Gammagard S/D (Solvent/Detergent) | DRUG | - |
Inclusion Criteria: * Be of Japanese descent, defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents. * Participants must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin ...
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Immune Globulin, 10% is an investigational therapy being studied for the treatment of Multifocal Motor Neuropathy and Primary Immunodeficiency Diseases (PID). It is currently in Phase 3 clinical development for these indications, though no active trials are ongoing as all five studies have been completed.
Immune Globulin, 10% is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted clinical trials for this product in the United States, Canada, Denmark, and several European countries.
Immune Globulin, 10% is in Phase 3 clinical development. The development program includes completed Phase 2 and Phase 3 trials, with a total of five studies completed and no active trials currently enrolling. It remains an investigational product and is not yet approved.
Immune Globulin, 10% has been studied in five completed trials. Key studies include NCT00666263, a Phase 3 trial for Multifocal Motor Neuropathy, and NCT00546871, a Phase 2 trial in Primary Immunodeficiency Diseases. Other trials include NCT01218438 and NCT01412385, which evaluated related formulations.
No, Immune Globulin, 10% is distinct from IGSC, 20%, which is a separate formulation studied in the Phase 2/3 trial NCT01218438 for Primary Immunodeficiency Diseases. The 10% and 20% products differ in concentration and are evaluated in different clinical trials within the same development program.