A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins

NCT07794735 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: TAK-664-40052026-000263-39
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary immunodeficiency disease (or PIDD) is a group of conditions in which the immune system does not work properly. Some people with PIDD do not make enough antibodies. Antibodies are proteins that help to either protect the body from infections or fight infections. The main type of antibodies that helps protect the body from infection is IgG. People who do not make enough IgG often need medical treatment that gives the body those antibodies. This treatment is called IgG replacement therapy. It can be given through a vein (intravenous or IV) or under the skin (subcutaneous SC). TAK-664 is approved worldwide for SC IG replacement therapy. The study wants to learn more about TAK-664 given to people with PIDD who have not yet been treated with IG (called 'treatment-naïve'). The main aim of the study is to check if giving TAK-664 daily for 5 days, and then once more 3 days later (Day 8), can raise IgG to the target level and keep IgG there. Another aim of the study is to learn if TAK-664 given once a week can keep the IgG at the target levels during the study. The study also wants to find out how much the IgG levels raise and learn how many infections occur and how they are treated.

Conditions

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=500 mg/dL

  Serum trough levels of total IgG will be determined by using validated assay methods.

  At Day 15

Secondary Outcomes (13)

• Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL on Day 8

  At Day 8

• Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL at Weeks 4, 6, and 9

  At Weeks 4, 6, and 9

• Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=700 mg/dL

  At Weeks 6, and 9

• Change in Total Serum IgG Trough Level of >=100 mg/dL From Baseline to Days 8 and 15

  Baseline up to Days 8 and 15

• Annualized Rate of All Infections

  From first dose of study drug up to end of trial (EOT) (up to 10 weeks)

Study Arms (1)

TAK-664, 150 mg/kg

EXPERIMENTAL

Participants will receive a loading regimen of TAK-664 infusions consisting of 5 consecutive daily doses of 150 milligrams per kilogram (mg/kg) from Days 1 to 5 during the loading period, followed by maintenance period with the same dose of weekly infusion from Week 1 to Week 8.

Biological: TAK-664

Interventions

TAK-664 BIOLOGICAL

Participants will receive TAK-664 infusion.

Also known as: CUVITRU, Immune globulin subcutaneous (IGSC) 20 percent (%) Solution

TAK-664, 150 mg/kg

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant or the participant's legally authorized representative is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator.
• The participant or the participant's legally authorized representative has provided informed consent or assent, if applicable (that is, in writing, documented via a signed and dated informed consent form \[ICF\]), and any required privacy authorization before the initiation of any trial procedures.
• The participant is at least 6 years of age at the time of signing the ICF or assent, if applicable.
• The participant has a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring IG replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee (Human Inborn Errors of Immunity: 2024 update on the phenotypic classification from the IUIS Expert Committee).
• The participant has never received immunoglobulin (IG) replacement treatment (that is, no prior IG replacement therapy).
• The participant must have an immunoglobulin G (IgG) level of less than or equal to (\<=) 400 milligrams per deciliter (mg/dL) at screening.
• If a participant has the potential to become pregnant, they must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the trial and for at least 30 days after the last administration of TAK-664.

You may not qualify if:

• The participant has significant proteinuria (greater than or equal to \[\>=\] 3 and/or known urinary protein loss greater than \[\>\]1 gram per 24 \[g/24\] hours or nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal impairment on screening laboratory testing (blood urea nitrogen \[BUN\] or creatinine \>2.5 × upper limit of the normal range \[ULN\]).
• The participant has immunoglobulin A (IgA) deficiency (IgA less than \[\<\] 0.07 grams per liter \[g/L\]) associated with known anti-IgA antibodies and a history of hypersensitivity.
• The participant has a condition(s) that could alter protein catabolism and/or IgG use (for example, protein-losing enteropathies or nephrotic syndrome).
• The participant has a known history of a positive result or is positive at screening for one or more of the following: hepatitis B virus surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), or PCR for human immunodeficiency virus (HIV) Type 1 and Type 2. Note: Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
• The participant has a known history or current diagnosis of thromboembolic episodes, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease, within 6 months before screening.
• The participant has a history of malignancy with less than 2 years of complete remission before screening or active malignancy requiring chemotherapy and/or radiotherapy.
• Note: Participants with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stable prostate cancer not requiring treatment are eligible.
• The participant has congestive heart failure (New York Heart Association class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure \>100 millimeters of mercury (mm Hg) and/or systolic blood pressure \>160 mm Hg during the screening period confirmed on 2 measures \>30 minutes apart).
• The participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, or primary antiphospholipid antibody syndrome.
• The participant has malignancies of lymphoid cells, such as chronic lymphocytic leukemia and non-Hodgkin's lymphoma, which may lead to secondary hypogammaglobulinemia.
• The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the trial or place the participant at undue medical risk.
• The participant has abnormal laboratory values at screening that meet any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
• Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 × ULN for the testing laboratory.
• Persistent severe neutropenia (defined as an absolute neutrophil count (ANC) \<=500 per cubic millimeters \[/mm\^3\]).
• The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator.

Sponsors & Collaborators

• Takeda: lead

Related Links

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MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Hizentra; gamma-Globulins; Solutions

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.