Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Phase 2CASCANCT06798012
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 2 study testing TAK-411 in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 20 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- What is being tested?
- TAK-411
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 14 May 2025to 8 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- The participant has a body weight of less than or equal to (<=) 150 kilogram (kg).
- The participant has a documented diagnosis of typical CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021 criteria.
- The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
- The participant has had disease activation within 24 months before screening, as documented in medical records and in the opinion of the investigator, defined as one of the following:
- Clinically meaningful deterioration of symptoms on interruption or dose reduction of IgG treatment.
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- Clinically meaningful deterioration of symptoms requiring IgG treatment dose increase with subsequent clinical improvement.
- Clinically meaningful deterioration of symptoms at the end of IgG treatment dose interval with improvement after next dose administration.
- The participant is on a stable dose of immunoglobulin treatment intravenously (IGIV) treatment, (within the dose range of 0.4 to 2.4 grams per kilogram [g/kg] every 2 to 6 weeks [inclusive]). A stable dose is defined as no change greater than 10 percentage (%) in frequency or dose of IGIV therapy within the 3 months before and throughout screening.
- The participant has an INCAT score between 0 and 7 (inclusive) at screening.
Who cannot join
- The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
- The participant has any neuropathy of other causes, including the following:
- Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy, Charcot-Marie-Tooth disease, and hereditary sensory and autonomic neuropathies.
- Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and nondiabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis.
- Multifocal motor neuropathy.
- Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
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- Diabetic peripheral neuropathy.
- The participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or that may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, and Parkinson's disease.
- The participant is required to take or has taken either of the following for treatment of CIDP:
- Immunomodulatory/immunosuppressive agents (except IGIV) that include, but are not limited to, complement inhibitors, efgartigimod, and chemotherapeutic drugs, within 3 months or 5 half-lives, whichever is longer, of screening.
- B-cell affecting biologics (e.g. rituximab) within 6 months of screening.
- Note: Participants on a long-term, stable dosing regimen of certain immunomodulatory agents (eg, hydroxychloroquine) for any disease other than CIDP may be eligible, provided the dose regimen has been stable for 3 months before screening and is expected to remain stable throughout the study.
- The participant has undergone plasma exchange within 3 months of screening.
- The participant has a history of malignancy with less than 2 years of complete remission before screening, or active malignancy requiring chemotherapy and/or radiotherapy.
- Note: Participants with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stable prostate cancer not requiring treatment are eligible.
- The participant has experienced deep vein thrombosis or arterial thromboembolic events (example, cerebrovascular accident, pulmonary embolism) within 12 months of screening.
- The participant has any medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the study or place the participant at undue medical risk.
- The participant has participated in another clinical study involving an IP or investigational device within 30 days before screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Trial locations and contacts
20 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 3 countries
United States13 sites, 13 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Site Contact, 404-727-1638, christina.nicole.fournier@emory.edu
Christina Nicole Fournier
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Site Contact, 617-667-2501, Agottli2@bidmc.harvard.edu
Fernanda Wajnsztajn Yungher
- Recruiting
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Columbia, Missouri, 65212-0001
Site Contact, wdavidarnold@health.missouri.edu
William Arnold
- Not yet recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Site Contact, 346-238-2295, bliao@houstonmethodist.org
Bing Liao
- Recruiting
UF Health Neurology - Jacksonville
Jacksonville, Florida, 32209
Site Contact, 904-244-9922, Michael.Pulley@jax.ufl.edu
Michael Pulley
- Recruiting
University of California San Diego
La Jolla, California, 92093
Site Contact, 619-543-3500, dferrey@health.ucsd.edu
Dominic Ferrey
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
Site Contact, 833-732-2484, support@VINTrials.com
Andrew Lerman
- Recruiting
Penn Blood Disorders Program - Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Site Contact, 503-494-0744, Chafic.Karam@Pennmedicine.upenn.edu
Chafic Karam
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Site Contact, 507-284-5236, pinto.marcus@mayo.edu
Marcus Pinto
- Recruiting
California Pacific Medical Center
San Francisco, California, 94109
Site Contact, 415-600-3604, Liberty.Jenkins@sutterhealth.org
Liberty Jenkins
- Recruiting
University of Washington
Seattle, Washington, 98195
Site Contact, 206-598-7688, mdweiss@uw.edu
Michael Weiss
- Recruiting
The Washington University
St Louis, Missouri, 63110
Site Contact, 314-273-8160, C.roach@wustl.edu
Charles Roach
- Recruiting
University of South Florida
Tampa, Florida, 33612
Site Contact, 813-974-9413, jessshaw@usf.edu
Kathleen Murray
Colombia5 sites, 5 recruiting
- Not yet recruiting
Hospital Universitario San Ignacio
Bogotá, D.C.
Site Contact, 57 (1) 5946161 ext. 2473, luciamarent@gmail.com
Alba Lucia Marentes Cubillos
- Not yet recruiting
Universidad del Rosario
Bogotá, 111711
Site Contact, drandresdiazcampos@gmail.com
Andres Diaz Campos
- Not yet recruiting
Fundacion Oftalmologica de Santander - FOSCAL
Bucaramanga, 680001
Site Contact, (577) 6382828, ivanmauricio@rocketmail.com
Ivan Peña
- Not yet recruiting
Fundacion Valle del Lili
Cali, Valle del Cauca Department, 760032
Site Contact, (602) 3319090 ext. 4022 - 4028, francisco.arias@fvl.org.co
Francisco Arias Mora
- Not yet recruiting
Neuro ClinicaS.A.S
Medellín, Antioquia, 50021
Site Contact, (604) 3222813, juan.solano@udea.edu.co
Juan Marcos Solano Atehortua
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Site Contact, 403-210-7006, chris.white@ahs.ca
Christopher White
- Not yet recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Site Contact, 416-340-3315, vera.bril@utoronto.ca
Vera Bril
About this study
Official title: 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)
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.
Read more
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.
- Being tested
- TAK-411
- Keywords
- Drug Therapy
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-411Biological
Also called Hypersialylated Immune Globulin G
TAK-411 IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TAK-411 | Experimental | Participants will receive TAK-411 400 milligrams per kilogram (mg/kg), IV infusion as an induction dose on Day 1 of initial treatment period. The induction dose may be repeated once after 3 weeks if participants exhibit no clinical change. Thereafter, participants will receive TAK-411 200 mg/kg, IV infusion every 3 weeks for a total of 24 weeks (initial treatment period), followed by an optional additional 27 weeks (extended treatment period). Receives: Biological: TAK-411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Improvement in Functional Ability at Week 24
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 from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Measured: At Week 24
Secondary outcomes (13)
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
Improvement in functional ability is defined as decrease of >=1 point in the adjusted INCAT score at 12 and 54 weeks compared with baseline (last assessment before first 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 from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Measured: At 12 and 54 weeks
Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
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 from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Measured: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in the Adjusted INCAT Score
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 from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Measured: Screening, at 12, 24 and 54 weeks
Number of Participants With Improvement in Functional Ability on Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
Improvement in functional ability defined as increase of greater than or equal to (>=) 4 points in the raw summed I-RODS score at 12, 24, and 54 weeks compared with baseline. I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows:0 (impossible to perform),1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Measured: At 12, 24 and 54 weeks
Change From Baseline in I-RODS Score
The I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. The I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows: 0 (impossible to perform), 1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Measured: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in I-RODS Score
The I-RODS is a validated, participants-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. The I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows: 0 (impossible to perform), 1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Measured: Screening, at 12, 24 and 54 weeks
Change From Baseline in Medical Research Council Sum Score (MRC-SS)
The MRC-SS is used clinician-reported measure of muscle strength. Assessments are conducted bilaterally on six muscle groups: upper arm abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsal flexors. Each muscle is rated from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength. The scores are summed to obtain the MRC-SS, which ranges from 0 (quadriplegic) to 60 (normal strength).
Measured: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in MRC-SS
The MRC-SS is used clinician-reported measure of muscle strength. Assessments are conducted bilaterally on six muscle groups: upper arm abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsal flexors. Each muscle is rated from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength. The scores are summed to obtain the MRC-SS, which ranges from 0 (quadriplegic) to 60 (normal strength).
Measured: Screening, at 12, 24 and 54 weeks
Change From Baseline in Bilateral Hand Grip Strength
Bilateral hand grip strength assessments will be performed by prescribing physicians or qualified designees using the Martin Vigorimeter, measuring strength in kilopascals (kPa) ranging from 0 to 160 kPa.
Measured: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in Bilateral Grip Strength
Bilateral hand grip strength assessments will be performed by prescribing physicians or qualified designees using the Martin Vigorimeter, measuring strength in kPa ranging from 0 to 160 kPa.
Measured: Screening, at 12, 24 and 54 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: From start of study drug administration up to 54 weeks
Number of Participants With Infusion Discontinuations, Interruptions, and Infusion Rate Reductions due to TAK-411 Related TEAEs
Measured: From start of study drug administration up to 54 weeks
Number of Participants With Antibodies Against Host Cell Proteins (HCP), Beta-1,4-galactosyltransferase (B4GalT1) and Alpha-2,6-sialyltransferase (St6Gal1)
Measured: Up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start14 May 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798012
- Sponsor's protocol ID
- TAK-411-2001
- Acronym
- CASCA
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06798012
- Acronym / sponsor ID
- CASCA / TAK-411-2001
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-411 | Experimental | Biological: TAK-411Participants will receive TAK-411 400 milligrams per kilogram (mg/kg), IV infusion as an induction dose on Day 1 of initial treatment period. The induction dose may be repeated once after 3 weeks if participants exhibit no clinical change. Thereafter, participants will receive TAK-411 200 mg/kg, IV infusion every 3 weeks for a total of 24 weeks (initial treatment period), followed by an optional additional 27 weeks (extended treatment period). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- The participant has a body weight of less than or equal to (<=) 150 kilogram (kg).
- The participant has a documented diagnosis of typical CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021 criteria.
- The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
- The participant has had disease activation within 24 months before screening, as documented in medical records and in the opinion of the investigator, defined as one of the following:
Key exclusion criteria (18 listed)
- The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
- The participant has any neuropathy of other causes, including the following:
- The participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or that may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, and Parkinson's disease.
- The participant is required to take or has taken either of the following for treatment of CIDP:
- Note: Participants on a long-term, stable dosing regimen of certain immunomodulatory agents (eg, hydroxychloroquine) for any disease other than CIDP may be eligible, provided the dose regimen has been stable for 3 months before screening and is expected to remain stable throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-411Also: Hypersialylated Immune Globulin GTAK-411 IV infusion. | Biological | TAK-411 |
Primary outcome
Number of Participants With Improvement in Functional Ability at Week 24
Time frame: At Week 24
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 from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
13 secondary outcomes
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
Time frame: At 12 and 54 weeks
Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
Time frame: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in the Adjusted INCAT Score
Time frame: Screening, at 12, 24 and 54 weeks
Number of Participants With Improvement in Functional Ability on Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
Time frame: At 12, 24 and 54 weeks
Change From Baseline in I-RODS Score
Time frame: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in I-RODS Score
Time frame: Screening, at 12, 24 and 54 weeks
Change From Baseline in Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in MRC-SS
Time frame: Screening, at 12, 24 and 54 weeks
Change From Baseline in Bilateral Hand Grip Strength
Time frame: Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks
Change From Screening in Bilateral Grip Strength
Time frame: Screening, at 12, 24 and 54 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to 54 weeks
Number of Participants With Infusion Discontinuations, Interruptions, and Infusion Rate Reductions due to TAK-411 Related TEAEs
Time frame: From start of study drug administration up to 54 weeks
Number of Participants With Antibodies Against Host Cell Proteins (HCP), Beta-1,4-galactosyltransferase (B4GalT1) and Alpha-2,6-sialyltransferase (St6Gal1)
Time frame: Up to 54 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-411 in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Colombia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Improvement in Functional Ability at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.