Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-881 · 6 trials · 3 indications
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881. An infusion was considered to be tolerable if the participant had tolerated both the recombinant human hyaluronidase (rHuPH20) and immune globulin subcutaneous (IGSC) 20 percent (%) components of TAK-881. The number of participants who tolerated all initiated infusions by TAK-881 treatment were reported in this outcome measure.
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881. The number of tolerable infusions by TAK-881 treatment were reported in this outcome measure.
Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced or the infusion was not interrupted or stopped, due to any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
| Arm | Type | Description |
|---|---|---|
| All Participants (HYQVIA and TAK-881) | EXPERIMENTAL | Ramp-up Epoch: Participants on IGIV or cIGSC will switch to HYQVIA during ramp-up epoch with gradually increasing doses/volumes. For participants switching from IGIV, first HYQVIA dose is given two weeks after their last IGIV infusion. For participants switching from cIGSC, first dose is given one week after a weekly infusion or two weeks after a bi-weekly infusion, using a SC investigational needle set. Treatment Epoch: After completing ramp-up, participants will enter HYQVIA dosing epoch 2-3 weeks later, depending on treatment interval. Those already on HYQVIA at screening will skip ramp-up and proceed directly to dosing phase, lasting 18 weeks for a 3-week interval and 20 weeks for 4-week interval. After HYQVIA PK sampling period, participants will switch to TAK-881 with a 1:1 dose conversion. TAK-881 dosing lasts 24 weeks with a SC infusion needle set. Extension Epoch: Post-TAK-881, participants will enter the extension epoch, continuing treatment for up to 3 years. |
| TAK-881 | EXPERIMENTAL | Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer \>=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion. |
| Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1) | EXPERIMENTAL | Participants aged \>=16 years will receive 6 or 8 infusions at full doses of TAK-881 followed by HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (applicable for participants pre-treated with HYQVIA). |
| Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2) | EXPERIMENTAL | Participants aged \>=16 years will receive 6 or 8 infusions at full doses of HYQVIA followed by TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (applicable for participants pre-treated with HYQVIA). |
| Single Arm Treatment Epoch: TAK-881 | EXPERIMENTAL | Pediatric participants aged 2 to \<16 years will receive 6 or 8 infusions at full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their prestudy IgG treatment (applicable for participants pre-treated with HYQVIA). |
| Cohort 1, Schedule B, Treatment Arm 1: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, subcutaneous (SC) injection, 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, 0.6 g/kg on Days 22 and 50 in ramp-up dosing manner. |
| Cohort 1, Schedule C, Treatment Arm 2: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. |
| Cohort 2, Schedule A, Treatment Arm 3: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50 in ramp-up dosing manner. |
| Cohort 2, Schedule B: Treatment Arm 4: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50 in ramp-up dosing manner. |
| Cohort 2, Schedule C: Treatment Arm 5: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. |
| Cohort 3, Schedule A: Treatment Arm 6: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50 in ramp-up dosing manner. |
| Cohort 3, Schedule B: Treatment Arm 7: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50 in ramp-up dosing manner. |
| Cohort 3, Schedule C: Treatment Arm 8: TAK-881 | EXPERIMENTAL | Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner. |
| TAK-881 1.0 g/kg | EXPERIMENTAL | Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1. |
| HyQvia 1g/kg | EXPERIMENTAL | Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1. |
| TAK-881 0.4 g/kg (in-line warmed) | EXPERIMENTAL | Participants will receive a single dose of TAK-881 comprising of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period. |
| TAK-881 1.0 g/kg (in-line warmed) | EXPERIMENTAL | Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. |
| TAK-881 1.0 g/kg (un-warmed) | EXPERIMENTAL | Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. |
| Name | Type | Description |
|---|---|---|
| TAK-881 | BIOLOGICAL | Participants will receive SC infusion of TAK-881. |
| HYQVIA | BIOLOGICAL | Participants will receive SC infusion of HYQVIA. |
| SC Investigational Needle Sets | DEVICE | The single-use only SC needle set will be used to administer TAK-881/HYQVIA to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. |
| Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) | DEVICE | The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. |
Inclusion Criteria * Participant is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator. * Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent Form \[ICF\]) and any ...
TAK-881 is an investigational monoclonal antibody being studied for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Primary Immunodeficiency Diseases (PID), and in healthy volunteers. It is developed by Takeda Pharmaceutical Company Limited (TAK) and is currently in Phase 3 clinical development for CIDP.
TAK-881 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential role in treating Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Primary Immunodeficiency Diseases (PID).
TAK-881 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is conducting clinical trials of TAK-881 in healthy volunteers and in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
TAK-881 is in Phase 3 clinical development for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). It has completed Phase 1 trials in healthy volunteers and is not yet approved by the FDA. The drug remains investigational and is still being evaluated in clinical studies.
TAK-881 has an active Phase 3 trial, NCT06747351, comparing it to HYQVIA in adults with CIDP. Completed Phase 1 trials include NCT05059977, NCT06895967, and NCT06935266, all in healthy volunteers in the United States. These studies assess safety, tolerability, and pharmacokinetics.
TAK-881 is not the same as HYQVIA. HYQVIA is a comparator drug in the Phase 3 CIDP trial NCT06747351, where TAK-881 is being studied against it. TAK-881 is an investigational monoclonal antibody, while HYQVIA is a separate product used as an active control in the study.