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Comparing TAK-881 and HYQVIA as maintenance treatment for adults with CIDP

A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Phase 3 Interventional Takeda · NCT06747351

This test will see if TAK-881 given under the skin works like HYQVIA for adults with CIDP who are already on IgG therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment59 (estimated)
Ages18 Years and up
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsrituximab, chemotherapy, prednisone
Locations52 sites (Scottsdale, Arizona and 51 other locations)
Trial IDNCT06747351 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares the pharmacokinetics of subcutaneous TAK-881 with HYQVIA for maintenance treatment in adults with CIDP. Participants already receiving IVIG, conventional SCIG, or HYQVIA will receive HYQVIA-equivalent dosing for about 20 weeks and then switch to TAK-881 for 24 weeks, with a ramp-up phase if needed for those switching from IVIG or SCIG. Clinic visits occur every 3–4 weeks during the main treatment phases, and an extension phase permits home infusions with visits every 12–24 weeks. The study focuses on PK comparability and also tracks safety and tolerability.

Who should consider this trial

Good fit: Adults with a neurologist-confirmed diagnosis of CIDP who previously responded to IgG and are on a stable monthly IgG dose equivalent of 0.4–2.4 g/kg (via IVIG, cIGSC, or HYQVIA) are ideal candidates.

Not a fit: Patients whose CIDP does not respond to IgG, who are on unstable or out-of-range dosing, or who have contraindications to subcutaneous immunoglobulin are unlikely to benefit from participation.

Why it matters

Potential benefit: If TAK-881 shows comparable pharmacokinetics to HYQVIA, patients could gain an alternative subcutaneous maintenance option that may support at-home infusions with similar symptom control.

How similar studies have performed: Facilitated subcutaneous IgG approaches including HYQVIA have been used successfully to maintain IgG levels and clinical stability in CIDP, so this PK-comparability approach builds on established work.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inflammatory Demyelinating PolyradiculoneuropathyImmunoglobulinfacilitated subcutaneous , Immunoglobulin
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.