MedTrace Logo

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

NCT05755035 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-02-03

No results posted yet for this study

Summary

The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older.

The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to \[\>=\]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than \[\<\]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.

Conditions

  • Primary Immunodeficiency Diseases (PID)

Interventions

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

BIOLOGICAL

HYQVIA

Participants will receive SC infusion of HYQVIA.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2026-01-20
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Germany
  • Netherlands
  • 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 NCT05755035 on ClinicalTrials.gov