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A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

NCT06076642 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-08

No results posted yet for this study

Summary

The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).

The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.

Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

DEVICE

Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)

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.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Baxalta Innovations GmbH, now part of Takeda

    collaborator UNKNOWN

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2028-05-16
Completion
2028-05-16
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Greece
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076642 on ClinicalTrials.gov