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New antibody therapy tested for long-term safety in immune-deficient patients

NCT ID NCT06076642

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests the long-term safety of TAK-881, a subcutaneous immunoglobulin treatment, in 53 adults and children with primary immunodeficiency diseases (PIDD) who completed a prior study. Participants receive regular infusions every 2-4 weeks and are monitored for side effects and infection rates. The goal is to see if this treatment remains safe and well-tolerated over time.

What this could mean

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

Active substance
TAK-881 (immune globulin with hyaluronidase)
What this could lead to
If successful, this could confirm a safe, convenient long-term treatment option to help people with PIDD fight infections.
What could go wrong
This is an extension study with no placebo group, so results are limited. Side effects like infusion reactions or infections may still occur.

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

53 people

The number who actually took part.

Started

Nov 2024

Expected to finish

May 2028

An estimate. End dates often move.

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 Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * Participant or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol. * Participant or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device (in US sites only), prior to the initiation of any study procedures. Exclusion Criteria * Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study. * New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study. * Participant was enrolled in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 \[NCT05755035\]). * Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. * Participant is a family member or employee of the investigator or the investigator's site staff. * Participants with potential to become pregnant who meet any one of the following criteria:- 1. Participant has a positive pregnancy test. 2. Participant does not agree to employ a highly effective form of contraception for the duration of the study. * If participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during 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

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598, United States

  • Allergy Partners of North Texas

    Dallas, Texas, 75230, United States

  • Allergy, Asthma and Immunology Center

    Tulsa, Oklahoma, 74136, United States

  • Central Georgia Infectious Disease Consultants

    Macon, Georgia, 31201, United States

  • Duke Asthma, Allergy and Airway Center

    Durham, North Carolina, 27705, United States

  • Fakultni nemocnice Motol a Homolka Ustav imunologie

    Prague, 150 06, Czechia

  • General Hospital of Thessaloniki

    Thessaloniki, 56429, Greece

  • Hospital Sant Joan de Deu Barcelona

    Barcelona, 08950, Spain

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK

    Martin, 036 01, Slovakia

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70118, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • NUDCH (National Institute of Childrens Diseases)

    Bratislava, 833 40, Slovakia

  • National Jewish Medical And Research Center

    Denver, Colorado, 80206-2761, United States

  • North Shore-Long Island Jewish Health Systems

    Great Neck, New York, 11021, United States

  • OKIA s.r.o

    Košice, 040 01, Slovakia

  • Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie

    Lodz, 90329, Poland

  • Rush University Medical Center-Allergy/ Immunology Center

    Chicago, Illinois, 60612-3852, United States

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois, 61761, United States

  • University Hospital Brno

    Brno, 62500, Czechia

  • University of California, Irvine Medical Sciences I

    Irvine, California, 92697, United States

  • University of South Florida

    St. Petersburg, Florida, 33701, United States

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-952, Poland

  • Wojskowy Instytut Medyczny Panstwowy Instytut

    Warsaw, 04-141, Poland

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