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A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT06747351 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-01-20

No results posted yet for this study

Summary

The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP.

The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks.

Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

BIOLOGICAL

HYQVIA

Participants will receive SC infusion of HYQVIA.

DEVICE

SC Investigational Needle Sets

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.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2028-06-25
Completion
2028-06-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Italy
  • Japan
  • Poland
  • Spain
  • Sweden

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 NCT06747351 on ClinicalTrials.gov