Phase 3
Completed N=12
An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Primary Immunodeficiency Disease
Source: ClinicalTrials.gov NCT04842643 ↗
Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs — 12; 3; 12 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs |
12; 3; 12 | — |
| PRIMARY Number of Participants With Drug-related and Non-related TEAEs |
9; 12 | — |
| PRIMARY Number of Participants With Severe, Local and Systemic TEAEs |
3; 8; 12 | — |
| PRIMARY Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs |
0; 12 | — |
| SECONDARY Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% |
6.14; 3.52; NA; 0.305; 11.0 | — |
| SECONDARY Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% |
5.36; 3.42; NA; 0.250; 8.98 | — |
| SECONDARY Annual Rate of Validated Acute Serious Bacterial Infections (ASBI) |
0.00 | — |
| SECONDARY Annual Rate of All Infections |
1.42 | — |
| SECONDARY Number of Days Participants Not Able to Attend School or Work to Perform Normal Daily Activities Due to Illness/Infection |
1.91 | — |
| SECONDARY Number of Days Participants on Antibiotics |
2.55 | — |
| SECONDARY Number of Hospitalizations Due to Illness or Infection |
0.21 | — |
| SECONDARY Length of Hospital Stay Due to Illness or Infection |
0.00 | — |
| SECONDARY Number of Acute Physician Visits Due to Illness/Infection |
2.66 | — |
| SECONDARY Number of Participants With Their Response for Treatment Preference Questionnaire |
0; 0; 3; 8; 0; 4 | — |
| SECONDARY Number of Participants With Tolerability Events Related to the Infusion of Study Drug |
1; 4; 1 | — |
Eligibility 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).
- 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.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
- 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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04842643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.