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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-411 | Biological | TAK-411 IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria
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:
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.
Key Exclusion Criteria
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92093 | United States |
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| Label | URL |
|---|---|
| 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. | View source |
| 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. | View source |
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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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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | Screening, at 12, 24 and 54 weeks |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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 | 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) | Up to 54 weeks |
| California Pacific Medical Center | Recruiting | San Francisco | California | 94109 | United States |
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| UF Health Neurology - Jacksonville | Recruiting | Jacksonville | Florida | 32209 | United States |
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| Visionary Investigators Network | Recruiting | Miami | Florida | 33133 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| The Curators of the University of Missouri on behalf of University of Missouri Health Care | Recruiting | Columbia | Missouri | 65212-0001 | United States |
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| The Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Penn Blood Disorders Program - Hospital of The University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Houston Methodist Research Institute | Not yet recruiting | Houston | Texas | 77030 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| University of Calgary | Not yet recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
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| University Health Network | Not yet recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Neuro ClinicaS.A.S | Not yet recruiting | Medellín | Antioquia | 50021 | Colombia |
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| Hospital Universitario San Ignacio | Not yet recruiting | Bogotá | D.C. | Colombia |
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| Fundacion Valle del Lili | Not yet recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
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| Universidad del Rosario | Not yet recruiting | Bogotá | 111711 | Colombia |
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| Fundacion Oftalmologica de Santander - FOSCAL | Not yet recruiting | Bucaramanga | 680001 | Colombia |
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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