New shot for nerve disease could mean fewer infusions

NCT ID NCT06747351

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a new, more concentrated antibody treatment (TAK-881) works similarly to the current standard (HYQVIA) for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). About 59 participants who already receive antibody infusions will switch to HYQVIA for 20 weeks, then TAK-881 for 24 weeks. The main goal is to compare drug levels in the blood, not symptom improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Immune globulin (antibodies) with hyaluronidase, given as a shot under the skin
What this could lead to: If successful, this could show that a more concentrated antibody treatment (TAK-881) works as well as the current standard (HYQVIA) for controlling CIDP, potentially offering a similar option with fewer infusions.
What could go wrong: This is a small, single-arm trial focused on drug levels in the blood, not on whether symptoms improve. It may not prove that TAK-881 is better or even as effective as existing treatments. Side effects from immune globulin can include headaches, allergic reactions, and blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 59 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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: 1. Screening INCAT disability score of between 3 and 7 inclusive. 2. Screening INCAT disability score of 2 (both points are from lower extremities). 3. 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. 4. 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). Exclusion Criteria * 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: 1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN), Charcot-Marie-Tooth (CMT) disease, and hereditary sensory and autonomic neuropathies (HSANs). 2. 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. 3. Multifocal motor neuropathy (MMN). 4. 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. * Participant has a known history of positive result for or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Note: Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible. * Participant has clinically significant anemia that precludes repeated blood sampling during the trial, or hemoglobin level of \<10.0 grams per deciliter (g/dL) at the time of screening. * Participant has any of the following laboratory values at screening: 1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>2.5\*upper limit of normal (ULN). 2. Platelet count \<100,000 cells per microliter (cells/µL). 3. Absolute neutrophil count \<1000 cells/µL. * If female, the participant is pregnant or lactating at the time of screening. * Participant has participated in another clinical trial involving an IMP or investigational device within 12 weeks or 5 half-lives, whichever is longer, before enrollment (except for participants rolling over from the Japan study TAK-771-3002) or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial. * Participant is a trial site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with a trial site employee who is involved in conduct of this trial or may consent under duress.

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

52 sites in 11 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
NOT_YET_RECRUITING

Brescia, 25123, Italy
Aarhus Universitetshospital
RECRUITING

Aarhus, Central Jutland, 8200, Denmark
Atrium Health Wake Forest Baptist
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Attikon University General Hospital
NOT_YET_RECRUITING

Athens, Attica, 12462, Greece
Az Ospedaliera Universitaria Policlinico G Martino
NOT_YET_RECRUITING

Messina, 98125, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
NOT_YET_RECRUITING

Rome, 00133, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
NOT_YET_RECRUITING

Orbassano, Torino, Piemonte, 10043, Italy
Azienda Ospedaliero Universitaria Pisana
NOT_YET_RECRUITING

Pisa, 56126, Italy
BCN Research, LLC
RECRUITING

Greenfield, Wisconsin, 53228, United States
Charite - Universitatsmedizin Berlin
NOT_YET_RECRUITING

Berlin, 12203, Germany
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Clinirem Sp zo.o.
RECRUITING

Lublin, Lublin Voivodeship, 20-064, Poland
Copenhagen University Hospital
NOT_YET_RECRUITING

Copenhagen, Capital Region, 2100d, Denmark
Copernicus Podmiot Leczniczy
NOT_YET_RECRUITING

Gdansk, Pomeranian Voivodeship, 80-462, Poland
Duke University Hospital
RECRUITING

Durham, North Carolina, 27710, United States
Fakultni nemocnice Hradec Kralove
NOT_YET_RECRUITING

Hradec Králové, 500 05, Czechia
Fondazione Istituto Neurologico Casimiro Mondino
NOT_YET_RECRUITING

Pavia, 27100, Italy
Higashimatsuyama Municipal Hospital
RECRUITING

Higashi-Matsuyama, Saitama, 355-0005, Japan
HonorHealth Neurology
RECRUITING

Scottsdale, Arizona, 85251, United States
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING

Valencia, 46026, Spain
Hospital de La Santa Creu I San Pau
NOT_YET_RECRUITING

Barcelona, 08041, Spain
INECO
NOT_YET_RECRUITING

Rosario, Santa Fe Province, 2000, Argentina
IRCCS Istituto Clinico Humanitas
NOT_YET_RECRUITING

Rozzano, Milano, Lombardia, 20089, Italy
Instituto Argentino de Investigacion Neurologica (IADIN)
NOT_YET_RECRUITING

Buenos Aires, C1015ABR, Argentina
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
NOT_YET_RECRUITING

Milan, Lombardy, 20132, Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
NOT_YET_RECRUITING

Nagoya, Aichi-ken, 455-8530, Japan
Juntendo University Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8431, Japan
Knight Neurology
RECRUITING

Rockledge, Florida, 32955, United States
Kumamoto University Hospital
RECRUITING

Kumamoto, Kumamoto, 860-8556, Japan
Medizinische Hochschule Hannover
NOT_YET_RECRUITING

Hanover, Lower Saxony, 30625, Germany
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Nara Medical University Hospital
NOT_YET_RECRUITING

Kashihara, Nara, 634-8522, Japan
Neurology Associates
RECRUITING

Maitland, Florida, 32751, United States
Neurology Rare Disease Center
RECRUITING

Denton, Texas, 76208, United States
Oddzial Kliniczny Neurologii
NOT_YET_RECRUITING

Krakow, Lesser Poland Voivodeship, 30-688, Poland
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Ospedale San Martino
NOT_YET_RECRUITING

Genova, 16132, Italy
Raleigh Neurology Associates
RECRUITING

Raleigh, North Carolina, 27607, United States
Sahlgrenska Universitetssjukhuset
RECRUITING

Gothenburg, Västra Götaland County, 41345, Sweden
Shiga University of Medical Science Hospital
NOT_YET_RECRUITING

Ōtsu, Shiga, 520-2192, Japan
Stanford Neuroscience Health Center
NOT_YET_RECRUITING

Palo Alto, California, 94304, United States
The University of Vermont Medical Center
NOT_YET_RECRUITING

Burlington, Vermont, 05401, United States
The Washington University
NOT_YET_RECRUITING

St Louis, Missouri, 63130, United States
Tohoku Medical and Pharmaceutical University Hospital
NOT_YET_RECRUITING

Sendai, Miyagi, 981-8558, Japan
Tokushima University Hospital
NOT_YET_RECRUITING

Tokushima, Tokuchima, 770-8503, Japan
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
NOT_YET_RECRUITING

Marburg, Hesse, 35043, Germany
University General Hospital of Patras
NOT_YET_RECRUITING

Patras, Peloponnese, 26504, Greece
University of North Carolina (UNC)
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of Ulm
NOT_YET_RECRUITING

Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Mannheim GmbH
NOT_YET_RECRUITING

Mannheim, Baden-Wurttemberg, 68167, Germany
Warszawski Uniwersytet Medyczny
NOT_YET_RECRUITING

Warsaw, Masovian Voivodeship, 02-097, Poland
Yale University School of Medicine
NOT_YET_RECRUITING

New Haven, Connecticut, 06510, United States

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