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    Summary
    EudraCT Number:2026-000263-39
    Sponsor's Protocol Code Number:TAK-664-4005
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-08-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2026-000263-39
    A.3Full title of the trial
    Multicenter, Prospective, Open-Label Trial to Evaluate PK, Safety, and Tolerability of TAK-664 in IG Treatment-Naïve Participants With Primary Immunodeficiency Diseases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
    A.4.1Sponsor's protocol code numberTAK-664-4005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address500 Kendall Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877-825-3327
    B.5.6E-mailTrialDisclosures@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CUVITRU
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCUVITRU
    D.3.2Product code TAK-664
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman normal immunoglobulin
    D.3.9.3Other descriptive nameHuman normal immunoglobulin
    D.3.9.4EV Substance CodeSUB14196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary immunodeficiency diseases (PID)
    E.1.1.1Medical condition in easily understood language
    Primary immunodeficiency diseases (PID)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether a loading dose of TAK-664 consisting of 5 consecutive daily doses (Day 1 to Day 5) of 150 mg/kg/day, followed by the first maintenance dose (Day 8) of TAK-664 of 150 mg/kg achieves total serum IgG trough level >=500 mg/dL, as measured on Day 15.
    E.2.2Secondary objectives of the trial
    1. To evaluate whether a loading dose of TAK-664 consisting of 5 consecutive daily doses (Day 1 to Day 5) of 150 mg/kg/day achieves total serum IgG trough levels >=500 mg/dL, as measured on Day 8.
    2. To evaluate whether a weekly dose of TAK-664 of 150 mg/kg starting from Week 1 through Week 8 maintains total serum IgG trough level >=500 mg/dL at various time points during the maintenance phase of the trial.
    3. To evaluate whether a weekly dose of TAK-664 of 150 mg/kg starting from Week 1 through Week 8 maintains total serum IgG trough level >=700 mg/dL at various time points during the maintenance phase of the trial.
    4. To evaluate the increase in total serum IgG trough levels during the loading period and through Day 15.
    5. To assess infections.
    6. To assess health care resource utilization (HRU) (antibiotics and hospitalizations).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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.
    2. 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.
    3. The participant is at least 6 years of age at the time of signing the ICF or assent, if applicable.
    4. 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).
    5. The participant has never received immunoglobulin (IG) replacement treatment (that is, no prior IG replacement therapy).
    6. The participant must have an immunoglobulin G (IgG) level of less than or equal to (<=) 400 milligrams per deciliter (mg/dL) at screening.
    7. 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.
    E.4Principal exclusion criteria
    1. 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]).
    2. 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.
    3. Participant has a condition(s) that could alter protein catabolism and/or IgG use (for example, protein-losing enteropathies or nephrotic syndrome).
    4. 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.
    5. 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.
    6. Participant has a history of malignancy with less than 2 years of complete remission before screening or active malignancy requiring chemotherapy and/or radiotherapy.
    7. 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).
    8. Participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, or primary antiphospholipid antibody syndrome.
    9. The participant has malignancies of lymphoid cells, such as chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, which may lead to secondary hypogammaglobulinemia.
    10. 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.
    11. 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]).
    12. Participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator.
    13. Participant has a known or suspected intolerance or hypersensitivity to compounds closely related to TAK-664 or any of the stated ingredients.
    14. Participant has an active infection and is receiving systemic antibiotic therapy for the treatment of infection at the time of screening.
    15. Participant is required to take or has taken:
    a. 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.
    b. Long-term systemic corticosteroids defined as a daily dose >1 mg/kg of prednisone-equivalent/day for >30 days within 3 months of screening.
    16. Participant has received a live-attenuated viral vaccination within 3 months of screening.
    17. Participant has known substance or prescription drug abuse within 12 months of screening.
    18. Participant is pregnant or breastfeeding at the time of screening or planning to become pregnant during participation in the trial.
    19. 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.
    20. 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.
    21. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=500 mg/dL
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 15
    E.5.2Secondary end point(s)
    1. Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL on Day 8
    2. Percentage of Participants who Achieve a Total Serum IgG Trough level of >=500 mg/dL at Weeks 4, 6, and 9
    3. Percentage of Participants who Achieve a Total Serum IgG Trough Level of >=700 mg/dL
    4. Change in Total Serum IgG Trough Level of >=100 mg/dL From Baseline to Days 8 and 15
    5. Annualized Rate of All Infections
    6. Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
    7. Duration of Infections
    8. Annualized Rate of Days on Oral or Parenteral Antibiotics for Prophylaxis or Treatment of Infections
    9. Number of Hospitalizations Due to Infections
    10. Total Number of Days of Hospital Stay Due to Infections
    11. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to TAK-664
    12. Number of Participants With TEAEs Temporally Associated With TAK-664
    13. Number of Infusions of TAK-664 Without Infusion Rate Reduction, Interruption, or Infusion Withdrawals due to TAK-664-related TEAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Day 8
    2. At Weeks 4, 6, and 9
    3. At Weeks 4, 6, and 9
    4. Baseline up to Days 8 and 15
    5. From first dose of study drug up to end of trial (EOT) (up to 10 weeks)
    6. From first dose of study drug up to EOT (up to 10 weeks)
    7. From first dose of study drug up to EOT (up to 10 weeks)
    8. From first dose of study drug up to EOT (up to 10 weeks)
    9. From first dose of study drug up to EOT (up to 10 weeks)
    10. From first dose of study drug up to EOT (up to 10 weeks)
    11. From first dose of study drug up to EOT (up to 10 weeks)
    12. From first dose of study drug up to EOT (up to 10 weeks)
    13. From first dose of study drug up to EOT (up to 10 weeks)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Being pediatric age group, subjects were not able to give consent, thus needed parent/caregiver to sign consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 9
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Takeda
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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