Primary Immunodeficiency Diseases (PID)Phase 4NCT07794735
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
A Phase 4 study testing TAK-664 in people with Primary Immunodeficiency Diseases (PID), run by Takeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- TAK-664
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- The participant has a known or suspected intolerance or hypersensitivity to compounds closely related to TAK-664 or any of the stated ingredients.
- The participant has an active infection and is receiving systemic antibiotic therapy for the treatment of infection at the time of screening.
- The participant is required to take or has taken:
- Immunomodulatory/immunosuppressive agents that include but are not limited to specific complement inhibitors, rituximab, neonatal Fc receptor inhibitors (for example, efgartigimod), and chemotherapeutic drugs, within 12 months of screening or 5 times the half-life (t1/2) plus 6 months before screening, whichever is longer.
- Long-term systemic corticosteroids defined as a daily dose >1 mg/kg of prednisone-equivalent/day for >30 days within 3 months of screening. Note: Participants using short-pulse dose corticosteroid course and oral daily corticosteroids <=10 milligrams per day (mg/day) prednisone-equivalent are allowed.
- The participant has received a live-attenuated viral vaccination within 3 months of screening.
- The participant has known substance or prescription drug abuse within 12 months of screening.
- The participant is pregnant or breastfeeding at the time of screening or planning to become pregnant during participation in the trial.
- The participant has a current or relevant history of physical or psychiatric illness or any medical disorder that may require treatment or make the participant unlikely to fully complete the trial or any condition that presents undue risk from the trial intervention or procedures.
- The participant has participated or is scheduled to participate in another clinical trial involving a trial intervention or investigational device within 30 days before screening and during the trial.
- The participant is a trial site employee, an immediate family member (for example, spouse, parent, child, or sibling), or is in a dependent relationship with a trial site employee who is involved in the conduct of this trial or may consent under duress.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter, Prospective, Open-Label Trial to Evaluate PK, Safety, and Tolerability of TAK-664 in IG Treatment-Naïve Participants With Primary Immunodeficiency Diseases
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').
Read more
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)
- Being tested
- TAK-664
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-664Biological
Also called CUVITRU, Immune globulin subcutaneous (IGSC) 20 percent (%) Solution
Participants will receive TAK-664 infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TAK-664 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 15
Secondary outcomes (13)
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL on Day 8
Serum trough levels of total IgG will be determined by using validated assay methods.
Measured: At Day 8
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL at Weeks 4, 6, and 9
Serum trough levels of total IgG will be determined by using validated assay methods.
Measured: At Weeks 4, 6, and 9
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=700 mg/dL
Serum trough levels of total IgG will be determined by using validated assay methods.
Measured: At Weeks 6, and 9
Change in Total Serum IgG Trough Level of >=100 mg/dL From Baseline to Days 8 and 15
Serum trough levels of total IgG will be determined by using validated assay methods.
Measured: Baseline up to Days 8 and 15
Annualized Rate of All Infections
The annual rate of infections will be calculated as the mean number of infections per participant per year.
Measured: From first dose of study drug up to end of trial (EOT) (up to 10 weeks)
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
The ASBI rate will be calculated as the mean number of acute serious bacterial infections per participant per year.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Duration of Infections
The duration of an infection will be calculated as the number of days between the AE start date and the AE end date. Infections will be extracted from adverse events (AE) reporting.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Annualized Rate of Days on Oral or Parenteral Antibiotics for Prophylaxis or Treatment of Infections
Annualized rate of days on oral or parenteral antibiotics will be calculated as the total number of days participants received oral or parenteral antibiotics for prophylaxis or treatment of infections divided by the total participant-years of follow-up.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Number of Hospitalizations Due to Infections
Number of hospitalizations due to infections will be standardized to per year.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Total Number of Days of Hospital Stay Due to Infections
Total number of days of hospital stay due to infections will be standardized to per year.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to TAK-664
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAEs are defined as AEs that started at or after the initiation of the first administration of TAK-664. Serious TEAEs are the AEs that result in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or are otherwise considered medically important. Any TEAE that is recorded by the investigator as related to TAK-664 is considered as TEAE related to TAK-664.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With TEAEs Temporally Associated With TAK-664
Temporally associated TEAEs are defined as TEAEs which begin during or within 72 hours of the completion of TAK-664 infusion.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Number of Infusions of TAK-664 Without Infusion Rate Reduction, Interruption, or Infusion Withdrawals due to TAK-664-related TEAEs
Number of infusions of TAK-664 without infusion rate reduction, interruption, or infusion withdrawals due to TAK-664-related TEAEs will be reported.
Measured: From first dose of study drug up to EOT (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794735
- Sponsor's protocol ID
- TAK-664-4005
- Other IDs
- 2026-000263-39
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Open-Label Trial to Evaluate PK, Safety, and Tolerability of TAK-664 in IG Treatment-Naïve Participants With Primary Immunodeficiency Diseases
- ClinicalTrials.gov ID
- NCT07794735
- Acronym / sponsor ID
- TAK-664-4005
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-664, 150 mg/kg | Experimental | Biological: TAK-664Participants 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-664Also: CUVITRU, Immune globulin subcutaneous (IGSC) 20 percent (%) SolutionParticipants will receive TAK-664 infusion. | Biological | TAK-664, 150 mg/kg |
Primary outcome
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=500 mg/dL
Time frame: At Day 15
Serum trough levels of total IgG will be determined by using validated assay methods.
13 secondary outcomes
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL on Day 8
Time frame: At Day 8
Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL at Weeks 4, 6, and 9
Time frame: At Weeks 4, 6, and 9
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=700 mg/dL
Time frame: At Weeks 6, and 9
Change in Total Serum IgG Trough Level of >=100 mg/dL From Baseline to Days 8 and 15
Time frame: Baseline up to Days 8 and 15
Annualized Rate of All Infections
Time frame: From first dose of study drug up to end of trial (EOT) (up to 10 weeks)
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Duration of Infections
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Annualized Rate of Days on Oral or Parenteral Antibiotics for Prophylaxis or Treatment of Infections
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Hospitalizations Due to Infections
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Total Number of Days of Hospital Stay Due to Infections
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to TAK-664
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Participants With TEAEs Temporally Associated With TAK-664
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Number of Infusions of TAK-664 Without Infusion Rate Reduction, Interruption, or Infusion Withdrawals due to TAK-664-related TEAEs
Time frame: From first dose of study drug up to EOT (up to 10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAK-664 in people with Primary Immunodeficiency Diseases (PID), run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=500 mg/dL (time frame: At Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.