Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06076642 | A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases | PHASE3 | ACTIVE NOT_RECRUITING | 53 | — | — | Nov 4, 2024 | May 16, 2028 | Apr 8, 2026 | 25 | United States, Czechia +5 |
| NCT05755035 | A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases | PHASE2 | COMPLETED | 65 | — | — | Oct 24, 2023 | Jan 20, 2026 | Feb 3, 2026 | 32 | United States, Czechia +6 |
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| HYQVIA | BIOLOGICAL | Participants will receive SC infusion of HYQVIA. |
Inclusion Criteria Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * Participant or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requireme...