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Primary Immunodeficiency Diseases (PID)Phase 3NCT06076642

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

A Phase 3 study testing TAK-881 and Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) in people with Primary Immunodeficiency Diseases (PID), run by Takeda at 25 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Primary Immunodeficiency Diseases (PID)
What is being tested?
TAK-881 and Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
25 sitesin 7 countries
Study dates
4 Nov 2024to 16 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:-
Show all 9Show fewer
  • Participant has a positive pregnancy test.
  • 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.

Trial locations and contacts

25 sites in 7 countries.

25 sites in 7 countries

United States13 sites

  • Rush University Medical Center-Allergy/ Immunology Center

    Chicago, Illinois, 60612-3852

  • Allergy Partners of North Texas

    Dallas, Texas, 75230

  • National Jewish Medical And Research Center

    Denver, Colorado, 80206-2761

  • Duke Asthma, Allergy and Airway Center

    Durham, North Carolina, 27705

  • North Shore-Long Island Jewish Health Systems

    Great Neck, New York, 11021

  • University of California, Irvine Medical Sciences I

    Irvine, California, 92697

  • Central Georgia Infectious Disease Consultants

    Macon, Georgia, 31201

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70118

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois, 61761

  • University of South Florida

    St. Petersburg, Florida, 33701

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Allergy, Asthma and Immunology Center

    Tulsa, Oklahoma, 74136

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-952

  • Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie

    Lodz, 90329

  • Wojskowy Instytut Medyczny Panstwowy Instytut

    Warsaw, 04-141

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04-730

Other trials in Poland

Slovakia3 sites

  • NUDCH (National Institute of Childrens Diseases)

    Bratislava, 833 40

  • OKIA s.r.o

    Košice, 040 01

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

    Martin, 036 01

Other trials in Slovakia

Czechia2 sites

  • University Hospital Brno

    Brno, 62500

  • Fakultni nemocnice Motol a Homolka Ustav imunologie

    Prague, 150 06

Other trials in Czechia

Denmark1 site

  • Aarhus Universitetshospital

    Aarhus, 8200

Other trials in Denmark

Greece1 site

  • General Hospital of Thessaloniki

    Thessaloniki, 56429

Other trials in Greece

Spain1 site

  • Hospital Sant Joan de Deu Barcelona

    Barcelona, 08950

Other trials in Spain

About this study

Official title: Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)

The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).

The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.

Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.

Read the detailed description

The study consists of two Epochs: Epoch 1 and Epoch 2. In Epoch 1 eligible participants will have the opportunity to receive TAK-881 for a minimum of 6 months. After 6 months in study TAK-881-3002, the results of the anti-rHuPH20 binding antibody assay from either study TAK-881-3001 (NCT05755035) or study TAK-881-3002 (Epoch 1) will be used to determine the next steps in the study:

  • Epoch 1: Participants with an anti-rHuPH20 antibody titer less than [<] 1:160 will complete the EOS visit on the day of the first non-investigational product (IP) infusion following Study Visit Week 25.
  • Epoch 2: Participants with an anti-rHuPH20 antibody titer greater than or equal to [>=] 1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or study TAK-881-3002 (Epoch 1), will continue with an additional two years of TAK-881 treatment and undergo safety follow-up and will complete the EOS visit on the day of the first non-IP infusion following study Visit Week 121.
Being tested
TAK-881, Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)
Medical subject headings
Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-881Biological

    Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).

    Participants will receive SC infusion of TAK-881.

  • Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)Device

    The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Study groups in NCT06076642
Study groupRoleWhat they receive
TAK-881ExperimentalEpoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer >=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.
Receives: Biological: TAK-881; Device: Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to Week 121

  2. Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs

    Measured: Up to Week 121

Secondary outcomes (28)

  1. Annualized Rate of all Infections

    Measured: Up to Week 121

  2. Annualized Rate of Acute Serious Bacterial Infections (ASBIs)

    Measured: Up to Week 121

  3. Annualized Rate of Episodes of Fever

    Measured: Up to Week 121

  4. Time to First ASBI

    Measured: Up to Week 121

  5. Duration of Infections

    Measured: Up to Week 121

  6. Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20

    Measured: Up to Week 121

  7. Trough Level of Total IgG

    Measured: Up to Week 121

  8. Doses of TAK-881

    Measured: Up to Week 121

  9. Treatment Interval of TAK-881

    Measured: Up to Week 121

  10. Number of Infusions Per Month With TAK-881

    Measured: Up to Week 121

  11. Number of Infusions Sites (Needle Sticks) per Month With TAK-881

    Measured: Up to Week 121

  12. Number of Infusions Sites (Needle Sticks) per infusion With TAK-881

    Measured: Up to Week 121

  13. Duration of Infusions (minutes) With TAK-881

    Measured: Up to Week 121

  14. Monthly Infusion Time (minutes/month) With TAK-881

    Measured: Up to Week 121

  15. Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With TAK-881

    Measured: Up to Week 121

  16. Infusion Volume per Site (milliliter/site) With TAK-881

    Measured: Up to Week 121

  17. Number of Participants who have Infusions of TAK-881 at Physical Location

    Physical location includes site/infusion center or home.

    Measured: Up to Week 121

  18. Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881

    Measured: Up to Week 121

  19. Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years

    TSQM-9 is a 9-item, validated, self-administered instrument to assess participants satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The item scores of each of the 3 domains are summed and transformed to create a total score of 0 (extremely dissatisfied) to 100 (extremely satisfied). Higher score indicates greater satisfaction in that domain.

    Measured: From Week 13 up to Week 121

  20. Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years

    The EQ-5D-5L is a validated, self-administered assessment of overall health designed by the EuroQol Group. The instrument consists of two components: the EQ-5D descriptive system and the standard vertical EQ visual analogue scale (EQ-VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has five response categories: no problems, slight problems, some or moderate problems, severe problems, or extreme problems. Participants will be asked to describe their health state that day by choosing one of 5 responses that reflect the levels of severity for each of the 5 dimensions. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. Higher score indicates best health status.

    Measured: From Baseline up to Week 121

  21. Treatment Preference Measured by a Disease-specific Questionnaire for TAK-881 in Participants Aged >=12 Years

    The disease-specific treatment preference questionnaire is a self-administered, non-validated scale to assess participant preference for various attributes of IgG therapy and accompanying devices, such as ease of use of administration of TAK-881 complexity of administration, and convenience. The questionnaire consists of two components. The first component asks participants to indicate the extent to which they like or dislike aspects of TAK-881, including treatment frequency, time, ease, convenience, and complexity. Each item has five response categories: like very much, like, no preference, dislike, and dislike very much. The second component is a single question asking whether they would choose to continue receiving treatment after the trial ends.

    Measured: At Weeks 25 and 73

  22. Number of Days not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or their Treatment or Other Illnesses

    Measured: Up to Week 121

  23. Number of Days on Antibiotics

    Measured: Up to Week 121

  24. Number of Hospitalizations With Indications (Infection or other Illnesses)

    Measured: Up to Week 121

  25. Number of Days of Hospitalization

    Measured: Up to Week 121

  26. Number of Acute Physician Visits Due to Infection or Other Illnesses

    Measured: Up to Week 121

  27. Infusion Preparation Time For TAK-881 by HCP

    Measured: Up to Week 121

  28. Infusion Preparation Time For TAK-881 by Participants/Caregiver

    Measured: Up to Week 121

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start4 Nov 2024
  3. Primary completion16 May 2028 (estimated)
  4. Study completion16 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06076642
Sponsor's protocol ID
TAK-881-3002
Other IDs
2023-505946-24-00, 2023
Status last verified
Apr 2026
First submitted
4 Oct 2023
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-881 and Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) in people with Primary Immunodeficiency Diseases (PID), run by Takeda at 25 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Poland, Slovakia, Czechia, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Week 121). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06076642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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