Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Immune Globulin Subcutaneous (Human)
TAK-881 · 3 trials · 2 indications
AUC0-tau;ss was defined as the area under the curve over one dosing interval at steady-state. The AUC0-tau;ss was calculated during the dosing interval after the last dose in each crossover epoch by the non-compartmental analysis (NCA) based on total IgG levels for TAK-881 and HYQVIA.
| 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). |
| 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 developed for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and primary immunodeficiency diseases (PID). It is in Phase 3 clinical development and has not been approved by the FDA. Takeda Pharmaceutical Company Limited is the developer.
TAK-881 is developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is running the clinical program for TAK-881 across CIDP and primary immunodeficiency disease indications.
TAK-881 is in Phase 3 clinical development. One Phase 3 trial in CIDP is currently recruiting, and a Phase 3 long-term safety study in primary immunodeficiency diseases is active but not recruiting. A Phase 2 study in PID has been completed.
TAK-881 has been studied in three registered trials. NCT06747351 is a recruiting Phase 3 study comparing TAK-881 with HYQVIA in adults with CIDP. NCT06076642 is a Phase 3 long-term safety study in PID, and NCT05755035 is a completed Phase 2 study in PID.
TAK-881 is not FDA approved. It remains an investigational monoclonal antibody in clinical development, with Phase 3 trials ongoing in chronic inflammatory demyelinating polyradiculoneuropathy and primary immunodeficiency diseases. No regulatory approval has been granted for any indication.
Across the registered TAK-881 trials, total enrollment is 118 participants. The recruiting Phase 3 CIDP study, NCT06747351, plans to enroll 59 adults. The Phase 3 PID long-term safety study, NCT06076642, enrolled 53 participants, and the completed Phase 2 PID study, NCT05755035, enrolled 65.