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NCT06798012 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 20
- Study locations
NCT06798012: Recruiting Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Takeda.
NCT06798012 is a Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) that is actively recruiting participants, run by Takeda. The registered enrollment target is 36 participants, below the 41-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798012, a Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Improvement in functional ability is defined as decrease of \>=1 point in INCAT score at Week 24 compared with baseline (last assessment before first investigational product \[IP\] administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging f
Conditions Studied
Interventions
- BIOLOGICAL TAK-411
Study Locations (20)
Florida
- UF Health Neurology - Jacksonville - Jacksonville
- Visionary Investigators Network - Miami
- University of South Florida - Tampa
California
- University of California San Diego - La Jolla
- California Pacific Medical Center - San Francisco
Missouri
- The Curators of the University of Missouri on behalf of University of Missouri Health Care - Columbia
- The Washington University - St Louis
Other
- Universidad del Rosario - Bogotá
- Fundacion Oftalmologica de Santander - FOSCAL - Bucaramanga
Georgia
- Emory University - Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
Pennsylvania
- Penn Blood Disorders Program - Hospital of The University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2028-06-08 |
| Phase | Phase 2 |
What NCT06798012 shows while recruiting
NCT06798012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 41-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) appearing as the primary indexed condition, and to 1 intervention - of which TAK-411 is the first listed.
NCT06798012 names 20 study sites across 15 states, led by Florida, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT06798012 about?
NCT06798012 is a clinical study titled "A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)". 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 mus...
What is the current status of trial NCT06798012?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-05-14. Estimated completion is 2028-06-08.
What conditions does trial NCT06798012 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
What interventions are being tested in trial NCT06798012?
The interventions under investigation include: TAK-411 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06798012?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798012 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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