For Healthcare Professionals

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease


About the study

This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study. They must have completed that study or be about to complete it before joining this study. Participants will continue treatment with IGCS, 20% in this study. The main aim of this study is to check for side effects from long-term treatment with IGSC, 20% . This medicine is not yet licensed in Japan, so participants will be treated with IGSC, 20% until it becomes commercially available.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001.

A participant is considered to have completed Study TAK-664-3001 successfully if they fulfill the following criterion: Completed Epoch 2, in which IGSC, 20% is administered weekly (completion of Epoch 3, in which IGSC, 20% is administered biweekly, is not mandatory for participation in TAK-664-3002 study).

  1. Written 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.
  2. 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 participation in Study TAK-664-3001 such that the Participant's safety or medical care would be impacted by participation in the extension study TAK-664-3002.
  2. Participant is scheduled to participate in another non-Takeda clinical study involving an Investigational Product or device-used-in-clinical-trial in the course of this study.
  3. If a female of childbearing potential, Participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Primary Immunodeficiency Disease

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Apr 30, 2024

Treatment type



Takeda identifier


Study number


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