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Comparison of TAK-881 and HyQvia for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition affecting the nerves that can cause weakness and reduced sensation in the arms and legs. The study will evaluate a medication called TAK-881, comparing it to another medication called HyQvia. Both medications contain human normal immunoglobulin, which helps fight infections and regulate the immune system.

The purpose of this research is to compare how these medications work in the body when given under the skin (through subcutaneous injection). The study will use various medical devices including an infusion pump and special needle sets to deliver the medication. Participants will receive treatment for approximately 27 weeks.

During the study, participants will receive either TAK-881 or HyQvia through regular injections under the skin. The medication will be given using specialized equipment to ensure proper delivery. Blood samples will be collected to measure the levels of the medication in the body over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive HyQvia treatment through subcutaneous infusion (under the skin) for a period of at least 12 weeks

    The treatment will be given with a dosage between 0.4 to 2.4 grams per kilogram of body weight per month

    The infusions will be administered every 2 to 6 weeks, depending on your individual treatment plan

  2. Step 2

    Transition to study medication

    After the initial phase, you will transition to receiving TAK-881, the study medication

    The medication will continue to be given through subcutaneous infusion

    The dosing schedule and amount will remain similar to your previous treatment

  3. Step 3

    Monitoring period

    Your body's response to the medication will be monitored through regular blood tests

    The main focus will be on measuring the levels of antibodies (IgG) in your blood

    Your neurological symptoms will be assessed using a standardized scale called INCAT disability score

  4. Step 4

    Study completion

    The study will continue until sufficient data is collected to compare both medications

    Regular assessments will continue throughout the study period

    The study is expected to conclude by May 2030

Who can join the trial?

12 criteria

  • Must be able to understand and follow all study procedures, as determined by the study doctor
  • Must provide written informed consent before starting any study procedures
  • Must be at least 18 years old
  • Must have a confirmed diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) by a nerve disease specialist
  • Must have shown improvement with previous immunoglobulin (IgG) treatment
  • Must be currently receiving stable treatment with immunoglobulin therapy for at least 12 weeks before screening, with specific dosing requirements:
    • Monthly dose between 0.4 to 2.4 grams per kilogram of body weight
    • Treatment intervals of 2-6 weeks for IGIV
    • Weekly or bi-weekly for cIGSC
    • Up to 6 weeks for HYQVIA
    • Must have an INCAT disability score (a measure of disability) between 0 and 7, meeting specific scoring criteria
    • For participants who can become pregnant:
      • Must have a negative pregnancy test at screening
      • Must agree to use effective birth control during the study and for 30 days after the last study treatment

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions or anaphylaxis to immunoglobulin treatments (antibody-based medications)
  • Active thrombosis (blood clots) or high risk of developing blood clots
  • Severe kidney problems or renal failure
  • Immunoglobulin A (IgA) deficiency with antibodies against IgA
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • Active infections or severe underlying health conditions
  • History of thromboembolic events (blood clots that travel through blood vessels) in the past 12 months
  • Significant liver disease or abnormal liver function tests
  • Uncontrolled hypertension (high blood pressure)
  • History of cancer within the past 5 years (except for successfully treated skin cancer)
  • Known allergies to any components of the study medication
  • Inability to comply with study procedures or follow-up visits
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
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Investigated drugs

  • TAK-881

    is an investigational medication being studied for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is administered through subcutaneous injection (under the skin).

  • HYQVIA

    is an established medication used to treat chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is an immune globulin infusion that is administered subcutaneously. The medication helps to provide antibodies that the body needs to protect against infections in people with weakened immune systems.

What is already known about the treatment

  • TAK-881

    An investigational medication administered subcutaneously (under the skin) that is being studied for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). This drug is currently in Phase 3 clinical trials and is being compared to HYQVIA for pharmacokinetic comparability. The medication is designed to work as an immunoglobulin therapy to help manage symptoms of CIDP, a neurological disorder affecting the peripheral nerves.

  • HYQVIA

    A subcutaneously administered immunoglobulin therapy that combines normal human immunoglobulin with recombinant human hyaluronidase to treat patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). This FDA-approved medication works by providing antibodies that help fight infections and regulate the immune system, while the hyaluronidase component helps improve the distribution and absorption of the immunoglobulin in the body. The medication is classified as an immune globulin therapy and is used as a replacement therapy in patients with compromised immune systems.

Investigated diseases

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - A neurological disorder that affects the peripheral nerves throughout the body. It occurs when the immune system attacks and damages the protective covering of nerves called myelin. The condition typically develops gradually over several weeks or months, causing progressive weakness and numbness in both arms and legs. Patients may experience decreased reflexes, tingling sensations, and difficulties with balance and coordination. The symptoms usually affect both sides of the body symmetrically and tend to worsen over time if left untreated. CIDP can affect both motor and sensory nerves, leading to muscle weakness and altered sensations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517450-95-00Protocol codeTAK-881-3003Estimated enrolment65 patientsSponsorTakeda Development Center Americas Inc.

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