Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech Republic

July 14, 2026 updated by: Takeda

Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD); Specific Therapeutic Program for Czech Republic: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 [NCT06076642], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.

All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.

Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.) and Czech Republic (the device is approved), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
  2. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
  3. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of this program and can provide written informed consent/assent (if applicable).
  4. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
  5. Participant does not have a known hypersensitivity to TAK-881 or its components.

Exclusion Criteria:

  1. Participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program.
  2. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-881 EAP
  • TAK-881-3002 PIDD EAP (Other Identifier: Takeda)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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