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Study on the Effects of TAK-881 and Hyaluronidase in Adults with Primary Immunodeficiency Diseases

Verified siteRegistered drugNo 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 Primary Immunodeficiency Diseases (PIDD), which are conditions where the immune system does not function properly, making it difficult for the body to fight infections. The study will evaluate a treatment called TAK-881, which is a solution for infusion containing human normal immunoglobulin and hyaluronidase (human recombinant). This treatment is compared to another medication known as HyQvia, which also contains human normal immunoglobulin. Both treatments are administered under the skin, a method known as subcutaneous administration.

The purpose of the study is to compare how the body processes these treatments and to assess their safety and tolerability in individuals aged 16 years and older with PIDD. Participants will receive both treatments at different times during the study. The study will monitor how the treatments are absorbed and used by the body, as well as any side effects that may occur. The study will also look at how often participants experience infections and how these affect their daily lives.

Participants will be involved in the study for a period of up to 27 weeks. During this time, they will receive regular infusions of the study medications and attend scheduled visits for monitoring. The study aims to provide valuable information on the effectiveness and safety of TAK-881 compared to HyQvia in managing Primary Immunodeficiency Diseases.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to provide informed consent. This involves understanding the study procedures and agreeing to participate.

    Eligibility will be confirmed based on specific criteria, including age and medical history related to primary immunodeficiency diseases.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish baseline health status. This includes a blood test to measure serum IgG levels, which should be above 5 g/L.

    Participants will also undergo a pregnancy test if applicable and agree to use effective contraception during the study.

  3. Step 3

    Treatment phase

    Participants will receive HyQvia, a solution for infusion, administered subcutaneously. The dosage will be based on the participant's body weight, ranging from 0.3 g/kg to 1 g/kg every four weeks.

    The treatment involves regular infusions, with intervals of 21 or 28 days, or 7 or 14 days for other forms of immunoglobulin treatments.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes tracking the annualized rate of infections and other health resource utilization metrics.

    Participants will have scheduled visits for blood sampling to evaluate pharmacokinetics, which involves understanding how the drug is processed in the body.

  5. Step 5

    Completion of study

    The study is expected to conclude by September 2026. Upon completion, participants will undergo a final assessment to evaluate overall health and any changes in their condition.

    Data collected will contribute to understanding the treatment's impact on primary immunodeficiency diseases.

Who can join the trial?

8 criteria

  • The patient must have a documented diagnosis of a type of **Primary Immunodeficiency Disease** that affects the body's ability to produce antibodies and requires **IgG replacement therapy**. This is based on guidelines from experts in the field.
  • The patient must be between 2 and less than 16 years old for one part of the study, or 16 years or older for another part of the study.
  • The patient must have been receiving a stable dose of regular treatment with specific **immunoglobulin therapies** for at least 12 weeks before the study. This means the treatment dose should not vary more than 25% from the average dose during this period.
  • The patient must have a certain level of **IgG** (a type of antibody) in their blood, measured at specific times before the study.
  • If the patient is a female who can become pregnant, she must have a negative pregnancy test and agree to use a highly effective form of birth control during the study.
  • The patient or their legal representative must be willing and able to follow the study's requirements, including blood sampling, for the entire duration of the study.
  • The patient or their legal representative must understand and agree to follow all study procedures and requirements, as determined by the study investigator.
  • The patient or their legal representative must provide written consent to participate in the study before any study procedures begin.

Who cannot join the trial?

3 criteria

  • Individuals who do not have Primary Immunodeficiency Diseases cannot participate. This refers to a group of disorders where part of the body's immune system is missing or does not function properly.
  • Participants must be at least 16 years old. Those younger than 16 are not eligible.
  • Both males and females can participate, but certain vulnerable populations may be excluded for safety reasons.
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Investigated drugs

  • TAK-881

    is a medication being studied for its effects on people with primary immunodeficiency diseases (PIDD). The trial aims to understand how the body processes this medication, as well as its safety and how well it is tolerated when given under the skin.

  • HYQVIA

    is another medication used in the study for comparison purposes. It is already used to treat primary immunodeficiency diseases and is administered under the skin. The trial compares how the body processes HYQVIA with TAK-881 to see if they are similar in their effects.

What is already known about the treatment

TAK-881 – TAK-881 is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating Primary Immunodeficiency Diseases (PIDD). The medication is designed to help boost the immune system in individuals with these conditions. At the molecular level, TAK-881 works by providing antibodies that the body needs to fight infections. It is classified as an immunoglobulin therapy, which is a type of treatment that uses antibodies to help the immune system function properly.

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. Individuals with these diseases are more susceptible to infections, which can be frequent, severe, and difficult to treat. The diseases can affect various parts of the immune system, including antibodies, white blood cells, and other immune components. Symptoms often include recurrent infections, fatigue, and in some cases, autoimmune disorders. The progression of these diseases can vary widely, with some individuals experiencing mild symptoms and others facing more severe health challenges. Early diagnosis and management are crucial to help reduce the risk of infections and improve quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-502095-23-01Protocol codeTAK-881-3001Estimated enrolment50 patientsSponsorTakeda Development Center Americas Inc.

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