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NCT Number: NCT06076642

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Brno, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:-
  • 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.

Treatment and study plan

TAK-881

Biological

Participants will receive SC infusion of TAK-881.

Other names: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).

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.

Primary outcomes

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

Secondary outcomes

  1. Annualized Rate of all Infections

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

  3. Annualized Rate of Episodes of Fever

    Time frame: Up to Week 121

  4. Time to First ASBI

    Time frame: Up to Week 121

  5. Duration of Infections

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

  7. Trough Level of Total IgG

    Time frame: Up to Week 121

  8. Doses of TAK-881

    Time frame: Up to Week 121

  9. Treatment Interval of TAK-881

    Time frame: Up to Week 121

  10. Number of Infusions Per Month With TAK-881

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

    Physical location includes site/infusion center or home.

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

    Time frame: Up to Week 121

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

    Time frame: From Week 13 up to Week 121

    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.

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

    Time frame: From Baseline up to Week 121

    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.

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

    Time frame: At Weeks 25 and 73

    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.

  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

    Time frame: Up to Week 121

  23. Number of Days on Antibiotics

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

  25. Number of Days of Hospitalization

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

  27. Infusion Preparation Time For TAK-881 by HCP

    Time frame: Up to Week 121

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

    Time frame: Up to Week 121

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Baxalta Innovations GmbH, now part of Takeda
  • Takeda Development Center Americas, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 11, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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