RecruitingPhase 2NCT06798012

A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

A Phase 2, Open-label, Proof-of-Concept Study to Investigate the Efficacy, Safety, and Tolerability of TAK-411 in Adult Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (The CASCA Study)


Sponsor

Takeda

Enrollment

36 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. In CIDP, the immune system attacks the protective covering around the nerves called myelin. Over time, these nerves lose their ability to send signals to the muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs among other symptoms. Participants with CIDP can be treated with a protein called immunoglobulin (or IG). TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed. It is made from IG that comes from human plasma. This study will test if TAK-411 can decrease inflammation and improve symptoms of CIDP. The main aim of this study is to check how TAK-411 affects the physical functioning of adults with CIDP when compared with results of the placebo group of a historical trial. Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed up for 3 weeks after last dose. During the study, participants may visit their study clinic up to approximately 21 times.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called TAK-411 for people with chronic inflammatory demyelinating polyradiculoneuropathy (cidp). The study is currently recruiting participants at 20 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTAK-411

TAK-411 IV infusion.


Locations(20)

University of California San Diego

La Jolla, California, United States

California Pacific Medical Center

San Francisco, California, United States

UF Health Neurology - Jacksonville

Jacksonville, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

The Curators of the University of Missouri on behalf of University of Missouri Health Care

Columbia, Missouri, United States

The Washington University

St Louis, Missouri, United States

Penn Blood Disorders Program - Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Houston Methodist Research Institute

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

University of Calgary

Calgary, Alberta, Canada

University Health Network

Toronto, Ontario, Canada

Neuro ClinicaS.A.S

Medellín, Antioquia, Colombia

Hospital Universitario San Ignacio

Bogotá, D.C., Colombia

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Universidad del Rosario

Bogotá, Colombia

Fundacion Oftalmologica de Santander - FOSCAL

Bucaramanga, Colombia

View Full Details on ClinicalTrials.gov

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NCT06798012


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