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TAK-771 · 3 trials · 3 indications
An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically significant laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not causality is suspected. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product.
Participants who developed anti-rHuPH20 binding antibody titers of \>=1:160 and neutralizing antibodies to rHuPH20 was reported.
The data was reported at Week 7, 11, 15, 19, 23, 27, and 31 for 4-Week interval and at Week 4, 7, 10, 13, 16, 19, 22, 25 and 28 for 3-Week interval.
Relapse was defined as worsening of functional disability defined as an increase of \>=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function.
The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kilopascal (kPa) ranging from 0 to 160 kPa.
| Arm | Type | Description |
|---|---|---|
| TAK-771 | EXPERIMENTAL | TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. |
| Epoch 1: TAK-771 Ramp up Period | EXPERIMENTAL | TAK-771 included IGI 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI was increased from 1/3 of full dose to full dose in 3 weeks for participants who received TAK-771 once every 3 weeks, or from 1/4 of full dose to full dose in 6 weeks for participants who received TAK-771 once every 4 weeks. |
| Epoch 2: TAK-771 Full Dose Treatment Period | EXPERIMENTAL | TAK-771 included Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval. |
| Cohort 1: TAK-771 for CIDP Participants | EXPERIMENTAL | TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. |
| Cohort 2: TAK-771 for MMN Participants | EXPERIMENTAL | TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. |
| Name | Type | Description |
|---|---|---|
| TAK-771 | DRUG | Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20) |
Inclusion Criteria: 1. Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340). 2. Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study pr...
TAK-771 is an investigational small molecule being studied for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and primary immunodeficiency diseases (PID). It has also been evaluated in multifocal motor neuropathy (MMN). TAK-771 is in Phase 3 clinical development and is not approved by regulatory authorities.
TAK-771 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in Phase 3 clinical trials for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and primary immunodeficiency diseases (PID).
TAK-771 is in Phase 3 clinical development. It is an investigational small molecule and has not been approved by regulatory authorities. Phase 3 trials for TAK-771 have been completed in Japan for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal motor neuropathy (MMN), and primary immunodeficiency diseases (PID).
TAK-771 has completed three Phase 3 trials in Japan. NCT05084053 studied TAK-771 in adults with CIDP and MMN. NCT05150340 studied TAK-771 in people aged 2 years and older with PID. NCT05513586 evaluated the long-term safety of TAK-771 in PID participants aged 2 years and older.
TAK-771 is the sole name provided for this investigational drug. It is a small molecule being developed by Takeda Pharmaceutical Company Limited for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and primary immunodeficiency diseases (PID). No alternative names have been associated with TAK-771 in its clinical trials.