RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Quick Facts

Study Start:2025-05-06
Study Completion:2028-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06747351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

HonorHealth Neurology
Scottsdale, Arizona, 85251
United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Neurology Associates
Maitland, Florida, 32751
United States
Knight Neurology
Rockledge, Florida, 32955
United States
The Washington University
St Louis, Missouri, 63130
United States
NYU Langone Health
New York, New York, 10016
United States
University of North Carolina (UNC)
Chapel Hill, North Carolina, 27599
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
Portland, Oregon, 97239
United States
Neurology Rare Disease Center
Denton, Texas, 76208
United States
The University of Vermont Medical Center
Burlington, Vermont, 05401
United States
BCN Research, LLC
Greenfield, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2028-06-25

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2028-06-25

Terms related to this study

Keywords Provided by Researchers

  • Immunoglobulin
  • facilitated subcutaneous , Immunoglobulin;
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Additional Relevant MeSH Terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)