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

Recruiting now · Phase 3

Conditions studied: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

In brief

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.

Key facts

Study ID

NCT06747351

Run by

Takeda

People needed

59

Starts

2025-05-06

Expected to finish

2028-06-25

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator.
• Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent Form [ICF]) and any required privacy authorization before the initiation of any trial procedures.
• Participant has a documented diagnosis of CIDP or possible CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2021 criteria.
• Participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
• Participant is on a stable, pretrial treatment with IGIV, cIGSC, or HYQVIA (also known as TAK-771 in Japan) within the dose range equivalent to a cumulative monthly IgG dose of 0.4 to 2.4 grams per kilogram (g/kg) body weight (BW) (inclusive) administered for at least 12 weeks before screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). The dosing interval must be weekly or biweekly for cIGSC dosing and less than or equal (<=) to 6 weeks for HYQVIA dosing. Prior to screening, variations in the dosing interval of up to +-7 days or monthly dose amount of up to +-20 percentage (%) between the participant's pretrial IgG infusions are acceptable.
• Participant has an INCAT disability score between 0 and 7 (inclusive). Participants will be eligible if one of the below eligibility criteria are met:
• Screening INCAT disability score of between 3 and 7 inclusive.
• Screening INCAT disability score of 2 (both points are from lower extremities).
• Screening INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record before screening. If a score was greater than 2 documented in the medical record before screening at least 2 points must be from lower extremities.
• Screening INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record before screening, at least 2 points must be from lower extremities.
• If a participant has the potential to become pregnant, they must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the trial and for at least 30 days after the last administration of the investigational medical product (IMP).

You may not qualify if…

• Participant with documented diagnosis of focal, multifocal, distal, or sensory CIDP, or possible focal, multifocal, distal, or sensory CIDP per the EFNS/PNS 2021 criteria.
• Participant has any neuropathy of other causes, including:
• Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN), Charcot-Marie-Tooth (CMT) disease, and hereditary sensory and autonomic neuropathies (HSANs).
• 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 non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis.
• Multifocal motor neuropathy (MMN).
• Drug, biologic, chemotherapy, or toxin-induced peripheral neuropathy.
• Participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or which may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy.
• Note: Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy and who have adequate glycemic control with hemoglobin A1c [HbA1c] level of less than (<) 7.5% at screening will be eligible for the trial, provided the electrodiagnostic criteria are consistent with the diagnosis of CIDP or possible CIDP consistent with the EFNS/PNS 2021 criteria and the participant agrees to maintain adequate glycemic control.
• Participant is required to take or has taken immunomodulatory/immunosuppressive agents (except IGIV, cIGSC, or fIGSC) that include but are not limited to specific complement inhibitors, rituximab, neonatal FC receptor inhibitors (e.g. efgartigimod), and chemotherapeutic drugs, within 6 months of screening.
• Participant is required to take or has taken long-term systemic corticosteroids defined as dosages greater than (>) 20 milligrams per day (mg/day) prednisone-equivalent for >30 days within 3 months of screening.
• Note: Participants using short-pulse dose corticosteroid course and oral daily corticosteroids <= 20 mg/day prednisone-equivalent are allowed.
• Participant has undergone plasma exchange within 3 months before screening.
• Participant has immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with a high titer of antibody to myelin-associated glycoprotein.
• Participant has immunoglobulin A (IgA) deficiency (IgA <0.07 grams per liter [g/L]) associated with known anti-IgA antibodies and a history of hypersensitivity to human immunoglobulin treatment.
• Participant has a condition(s) which could alter protein catabolism and/or IgG use (for example [eg.] protein losing enteropathies, and nephrotic syndrome).
• Participant has a history or clinical manifestations of chronic kidney disease, or glomerular filtration rate of <30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
• 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.
• Participant has congestive heart failure (New York Heart Association class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure >100 millimeters of mercury (mm Hg) and/or systolic blood pressure >160 mm Hg during the screening epoch confirmed on 2 measures >30 minutes apart).
• Participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, and primary antiphospholipid antibody syndrome.
• Participant has a history of deep vein thrombosis or arterial thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months before screening.
• 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 trial or place the participant at undue medical risk.
• Participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, IGSC, and/or immune serum globulin infusions.
• Participant has a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the Investigator's Brochure (IB)/package insert/Summary of Product Characteristics (SmPC).
• Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20.

Where it is running

• Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Higashimatsuyama Municipal Hospital — Higashi-Matsuyama, Saitama, Japan (enrolling)
• Sahlgrenska Universitetssjukhuset — Gothenburg, Västra Götaland County, Sweden (enrolling)
• Raleigh Neurology Associates — Raleigh, North Carolina, United States (enrolling)
• HonorHealth Neurology — Scottsdale, Arizona, United States (enrolling)
• Neurology Associates — Maitland, Florida, United States (enrolling)
• Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (enrolling)
• Knight Neurology — Rockledge, Florida, United States (enrolling)
• Clinirem Sp zo.o. — Lublin, Lublin Voivodeship, Poland (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• Aarhus Universitetshospital — Aarhus, Central Jutland, Denmark (enrolling)
• Neurology Rare Disease Center — Denton, Texas, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• BCN Research, LLC — Greenfield, Wisconsin, United States (enrolling)
• University of North Carolina (UNC) — Chapel Hill, North Carolina, United States (enrolling)
• The University of Vermont Medical Center — Burlington, Vermont, United States
• Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill — Portland, Oregon, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Washington University — St Louis, Missouri, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Ulm — Ulm, Baden-Wurttemberg, Germany
• Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg — Marburg, Hesse, Germany
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
• Universitätsklinikum Mannheim GmbH — Mannheim, Baden-Wurttemberg, Germany

Full record on ClinicalTrials.gov

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