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

Primary Immunodeficiency Disease Clinical Trial

Official title:

A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842643
• Other study ID #: TAK-664-3002
• Secondary ID: U1111-1265-9447j
• Status: Completed
• Phase: Phase 3
• Start date: April 27, 2021
• Est. completion date: April 25, 2024

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 25, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. 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.

3. 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.

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Disease
• Primary Immunodeficiency Diseases

Intervention

Biological:
• IGSC 20% infusion
IGSC 20% infusion, The dose of IGSC will be established in previous study (TAK-664-3001)

Locations

Country	Name	City	State
Japan	Kyushu University Hospital	Fukuoka
Japan	Gifu University Hospital	Gifu
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	National defense medical college Hospital	Tokorozawa	Saitama
Japan	Tokyo Medical Dental University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Treatment emergent adverse events are defined as AEs with onset after date/time of first dose of study drug in Study-TAK-664-3001, or medical conditions present prior to the start of study drug Study-TAK-664-3001 but increased in severity or relationship after date/time of first dose of study drug in Study-TAK-664-3001. An AE is defined as any untoward medical occurrence in a clinical investigation subject administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. Number of participants with TEAEs will be assessed.	Up to 3 years
Secondary	Serum Trough Levels of Immune Globulin G (IgG) Antibodies Following Weekly Administration of IGSC, 20%	Serum trough levels of IgG antibodies measured during treatment after Epoch 2 of the previous study will be assessed.	Baseline, Every 12 weeks after first dose up to 3 years
Secondary	Serum Trough Levels of IgG Subclasses Following Weekly Administration of IGSC, 20%	Serum trough levels of IgG subclasses measured during treatment after Epoch 2 of the previous study will be assessed.	Baseline, Every 12 weeks after first dose up to 3 years
Secondary	Serum Trough Levels of IgG Antibodies Following Biweekly Administration of IGSC, 20%	Serum trough levels of IgG antibodies measured during treatment after Epoch 3 of the previous study will be assessed.	Baseline, Every 12 weeks after first dose up to 3 years
Secondary	Serum Trough Levels of IgG Subclasses Following Biweekly Administration of IGSC, 20%	Serum trough levels of IgG subclasses measured during treatment after Epoch 3 of the previous study will be assessed.	Baseline, Every 12 weeks after first dose up to 3 years
Secondary	Annual Rate of Validated Acute Serious Bacterial Infections (ASBI)	The ASBI rate will be calculated as the mean number of ASBI per participants per year. Annual rate of validated ASBI per participant will be assessed.	Baseline, Up to 3 years
Secondary	Annual Rate of All Infections	Annual rate is the number of participants reporting any infection per year.	Baseline, Up to 3 years
Secondary	Number of Days Participants not Able to Attend School or Work to Perform Normal Daily Activities due to Illness/Infection	Number of days not able to attend school or work to perform normal daily activities due to illness/infection will be assessed.	Baseline, Up to 3 years
Secondary	Number of Days Participants on Antibiotics	Number of days participants on antibiotics will be assessed.	Baseline, Up to 3 years
Secondary	Number of Hospitalizations due to Illness or Infection	Number of hospitalizations due to illness or infection will be assessed.	Baseline, Up to 3 years
Secondary	Length of Hospital Stay due to Illness or Infection	Number of days due to illness or infection will be assessed.	Baseline, Up to 3 years
Secondary	Number of Acute Physician Visits due to Illness/Infection	Number of acute (urgent or unscheduled) physician visits due to illness/infection will be reported.	Baseline, Up to 3 years
Secondary	Treatment Preference	Treatment preference questionnaire is a self-administered questionnaire developed to assess participants' preference towards the administration of new IGSC therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment.	Baseline, End of study (3 years)

External Links

•   To obtain more information on the study, click here/on this link