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New drug shows promise for long-term immune deficiency treatment

NCT ID NCT05513586

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked the long-term safety of TAK-771 in 15 Japanese patients with primary immunodeficiency disease (PID). Participants received TAK-771 injections for up to 3 years. The main goal was to monitor side effects and immune reactions. The study is now complete.

What this could mean

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

Active substance
TAK-771 (immune globulin with hyaluronidase)
What this could lead to
If successful, this could confirm that TAK-771 is safe for long-term use in managing primary immunodeficiency diseases.
What could go wrong
This is a small, open-label extension study with only 15 participants, so results may not apply to all patients. Side effects are still possible.

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

15 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

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

2 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: 1. Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340). 2. Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is \<18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate. 3. Participant is willing and able to comply with the requirements of the protocol. Exclusion Criteria: 1. Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study. 2. Participant is willing to participate in other clinical trials. 3. Women of childbearing potential who meet any one of the following criteria: 1. Participant presents with a positive pregnancy test. 2. Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom \[for male partner\], or birth-control pills) throughout the course of the study.

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Conditions

The condition(s) this trial relates to.

inborn error of immunity Primary Immunodeficiency Diseases

As listed by the trial registrant

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

Primary immunodeficiency diseases (PID)

Contacts and locations

Locations

  • Gifu University Hospital

    Gifu, Japan

  • Hiroshima University Hospital

    Hiroshima, Japan

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, Japan

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • Saitama Prefectual Children's Medical Center

    Saitama, Japan

  • Shizuoka Childrens Hospital

    Shizuoka, Japan

  • Tokyo Medical Dental University Hospital

    Bunkyo-ku, Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.