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Study on Long-term Safety of TAK-881 (Human Normal Immunoglobulin, Hyaluronidase) for Patients with Primary Immunodeficiency Diseases

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the long-term safety and tolerability of a treatment called TAK-881 in individuals with Primary Immunodeficiency Diseases (PIDD). These are a group of disorders where part of the body's immune system is missing or does not function properly, making it harder for the body to fight off infections. The treatment being tested, TAK-881, is a solution for infusion that contains two main components: human normal immunoglobulin and hyaluronidase (human recombinant). Human normal immunoglobulin is a blood-derived substance that helps boost the immune system, while hyaluronidase is an enzyme that helps the body absorb the immunoglobulin more effectively.

The purpose of this study is to evaluate how safe and tolerable TAK-881 is for people with PIDD over a long period. Participants in the study will receive the treatment through a method called subcutaneous infusion, which means the solution is slowly delivered under the skin using a small needle. The study will monitor participants for any side effects or reactions to the treatment, as well as how well the treatment helps in reducing infections and improving overall health. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups to assess their health and any changes in their condition. The study will also gather information on how the treatment affects the participants' quality of life, including their ability to perform daily activities and their satisfaction with the treatment. The study aims to provide valuable information on the long-term use of TAK-881 for managing Primary Immunodeficiency Diseases.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing Study TAK-881-3001.

    If female and capable of becoming pregnant, a negative pregnancy test is required at the start. A highly effective form of contraception must be used throughout the study.

  2. Step 2

    Treatment administration

    The medication used is a solution for infusion containing human normal immunoglobulin and hyaluronidase (human recombinant).

    The medication is administered subcutaneously, meaning it is injected under the skin.

    The dosage and frequency of the medication, referred to as TAK-881, will be determined by the study protocol.

  3. Step 3

    Monitoring and evaluation

    The primary focus is on the occurrence of any side effects related to the treatment, known as TEAEs (treatment-emergent adverse events).

    Monitoring includes checking for any interruptions or changes in the infusion process due to these side effects.

  4. Step 4

    Secondary assessments

    The study will evaluate the efficacy of the treatment by tracking infection rates and other health indicators.

    The presence of antibodies against the treatment will be checked to assess immunogenicity.

    The pharmacokinetics of the treatment will be studied by measuring the levels of immunoglobulin in the blood.

    The treatment regimen, including dosage and intervals, will be documented.

  5. Step 5

    Infusion details

    The number of infusions per month and the number of needle sticks per infusion will be recorded.

    The duration and volume of each infusion, as well as the maximum infusion rate, will be monitored.

  6. Step 6

    Patient feedback

    Satisfaction with the treatment will be evaluated using a questionnaire.

    Quality of life related to health will be assessed through a specific survey.

  7. Step 7

    Resource utilization

    The study will track days missed from work or daily activities due to illness or treatment.

    The use of antibiotics, hospitalizations, and doctor visits will be documented.

  8. Step 8

    Study duration

    The study is expected to continue until February 13, 2029.

Who can join the trial?

3 criteria

  • The patient must have completed Study TAK-881-3001.
  • If the patient is a female who can have children, she must have a negative pregnancy test at the start of the study and agree to use a very reliable method of birth control while participating in the study.
  • The patient or their legally authorized representative must be willing and able to follow the study's rules and requirements.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Primary Immunodeficiency Diseases cannot participate. Primary Immunodeficiency Diseases are conditions where the immune system does not work properly.
  • Participants must be within certain age ranges, which are not specified here, but if you are outside these age ranges, you cannot participate.
  • Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
  • If you are considered part of a vulnerable population, you may not be eligible. Vulnerable populations include groups that may need special protection, like children or people with certain disabilities.
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Investigated drugs

TAK-881 is a medication being studied for its long-term safety and tolerability in people with primary immunodeficiency diseases (PIDD). This trial aims to understand how well patients can tolerate this medication over an extended period and to ensure it is safe for use in managing their condition.

What is already known about the treatment

TAK-881 – TAK-881 is administered through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Currently, TAK-881 is being studied in clinical trials to assess its long-term safety and tolerability for individuals with Primary Immunodeficiency Diseases (PIDD). The main therapeutic indication for TAK-881 is to help manage and treat these immune system disorders. At the molecular level, TAK-881 works by enhancing or supporting the immune system's function, although the exact mechanism of action is still under investigation. It is classified pharmacologically as an immunomodulatory agent, which means it helps regulate or normalize the immune system's activity.

Investigated diseases

Primary Immunodeficiency Diseases – These are a group of disorders where part of the body's immune system is missing or does not function properly. They are usually caused by genetic mutations and can lead to increased susceptibility to infections. Individuals with these diseases may experience frequent, severe, or unusual infections that can affect various parts of the body. The progression of these diseases can vary widely, with some individuals experiencing mild symptoms and others having more severe health issues. Over time, the repeated infections can lead to complications and affect overall health. The diseases are often diagnosed in childhood, but some forms may not become apparent until adulthood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505946-24-00Protocol codeTAK-881-3002Estimated enrolment37 patientsSponsorBaxalta Innovations GmbH

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