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CompletedNCT05755035Updated Sep 30, 2026Results posted

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

A Phase 2/3 interventional study of TAK-881 and HYQVIA in Primary Immunodeficiency Diseases (PID), sponsored by Takeda. Completed at 32 sites in 8 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Takeda · Phase 2/3, Interventional, and Treatment

Updated Sep 30, 2026Results postedPrimary outcomes revisedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older.

The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to [>=]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than [\<]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.

Read the detailed description

The study consists of a screening epoch, a ramp-up epoch (if needed) and treatment epochs. Participants who have been receiving conventional subcutaneous intravenous immunoglobin G (cIGSC) or intravenous immunoglobulin G (IGIV) before the study, will enter a ramp-up epoch which will start 1, 2, 3 or 4 weeks after the last cIGSC or IGIV pre study dose before screening. Participants who have already been receiving HYQVIA treatment before the study, will directly enter the treatment epochs after screening. Participants aged greater than or equal to [>=]16 years will be randomized at a 1:1 ratio to one of the following treatment sequences: either TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881. Each participant aged >=16 years will complete both crossover epochs. Pediatric participants aged 2 to less than [\<]16 years will complete a single arm treatment with the study drug (TAK-881 only).

02

Conditions studied

  • Primary Immunodeficiency Diseases (PID)

Keywords

  • Immunoglobulin replacement therapy; facilitated subcutaneous
  • Immunoglobulin; primary immunodeficiency disease
03

In context

Primary Immunodeficiency Diseases

199 studies on the registry are indexed under Primary Immunodeficiency Diseases; 46 are open to participants now.

This study's enrollment of 65 is above the median of 37 across 121 interventional studies indexed under Primary Immunodeficiency Diseases.

Browse Primary Immunodeficiency Diseases studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee.
  • Participant is 2 years to \<16 years at the time of signing the informed consent form (ICF) for the single arm treatment part of the study OR 16 years or older at the time of signing the ICF for the crossover part of the study.
  • Participant has received a stable dose of regular treatment with any IGIV OR HYQVIA with a treatment interval of every 21 or 28 days OR any cIGSC with a treatment interval of every 7 or 14 days over a period of at least 12 weeks prior to screening at a minimum prestudy IgG dose equivalent to 0.3 grams per kilograms per body weight per 4 weeks (g/kg BW/4 weeks) and a maximum dose equivalent to 1 g/kg BW/4 weeks. Over that period, the participant should have been on the same product of IGIV, HYQVIA, or cIGSC. A stable dose is defined as one that deviates less than +-25 percentage (%) from the mean dose for all IgG infusions within this 12-week period prior to screening. Variations in the treatment interval of up to +-5 days for participant with a 28-day treatment interval and of up to +-3 days for participant with a 7, 14, or 21-day treatment interval are acceptable up to the first IP infusion.

  • Participant has a serum trough level of IgG greater than (>) 5 grams per liter (g/L) at the following time points:

    1. At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and
    2. Within 12 weeks prior to screening.
  • If female of childbearing potential, participant presents with a negative pregnancy test and agrees to employ highly effective form of contraception for the duration of the study.
  • Participant, or in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol, including PK blood sampling, for the duration of the study.

Informed Consent

  • The participant or, in the case of minors, legally designated representative(s) is/are willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
  • The participant or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated ICF and/or eConsent, if available), and any required privacy authorization prior to the initiation of any study procedures.

Exclusion criteria

Exclusion Criteria

  • Participant has a known history of a positive result or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening is eligible.

  • Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):

    1. Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5* the upper limit of normal (ULN) for the testing laboratory.
    2. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] less than and equal to (\<=) 500 per cubic millimeter (/mm\^3).
  • Known history of chronic kidney disease or estimated glomerular filtration rate (eGFR) of \<60 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
  • Participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator.
  • Participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or immune serum globulin infusions.
  • Participants with a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the Investigator's Brochure (IB)/package insert/Summary of Product Characteristics (SmPC).
  • Known substance or prescription drug abuse within 12 months of screening.
  • Participant has immunoglobulin A (IgA) deficiency (IgA less than 0.07 g/L) associated with known anti-IgA antibodies and a history of hypersensitivity.
  • Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20.
  • Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
  • Participant has a bleeding disorder, or a platelet count less than 20,000 per microliter (mcL), or in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of immune globulin subcutaneous (IGSC) therapy.
  • Treatment with immunosuppressants including chemotherapeutic agents, immunomodulators, and long-term systemic corticosteroid (defined as a daily dose of >1 mg of prednisone equivalent/kg/day for >30 days) within 12 weeks prior to screening. Short or intermittent courses (\<=10 days) of corticosteroids are allowed.
  • Live-attenuated viral vaccination within 12 weeks prior to screening.
  • History or current diagnosis of thrombotic episodes; venous thrombus that occurred in association with a medical device >2 years prior to screening are allowed.
  • Participant has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator.
  • Participant has a medical condition, laboratory finding, or physical examination finding that precludes participation, or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the study or place the participant at undue medical risk.
  • Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening.
  • Participant is scheduled to participate in another clinical study involving an IP (except for participants scheduled to enroll in a long-term follow-up study with TAK-881) or investigational device during the course of this study.
  • Participant is a family member or employee of the investigator or the investigator's site staff.
  • If female, participant is pregnant or lactating at the time of screening.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1)

    Participants aged \>=16 years will receive 6 or 8 infusions at full doses of TAK-881 followed by HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (applicable for participants pre-treated with HYQVIA).

    Biological: TAK-881 · Biological: HYQVIA

  • Experimental
    Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2)

    Participants aged \>=16 years will receive 6 or 8 infusions at full doses of HYQVIA followed by TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (applicable for participants pre-treated with HYQVIA).

    Biological: TAK-881 · Biological: HYQVIA

  • Experimental
    Single Arm Treatment Epoch: TAK-881

    Pediatric participants aged 2 to \<16 years will receive 6 or 8 infusions at full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their prestudy IgG treatment (applicable for participants pre-treated with HYQVIA).

    Biological: TAK-881

Interventions

  • BiologicalTAK-881

    Participants will receive SC infusion of TAK-881.

    Also known as: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).

  • BiologicalHYQVIA

    Participants will receive SC infusion of HYQVIA.

    Also known as: Immune Globulin Infusion (Human), 10% Solution with rHuPH20.

06

What researchers measure

Primary outcomes

  1. Area Under the Curve Over One Dosing Interval at Steady-State (AUC0-tau;ss) of Total IgG Levels With TAK-881 and HYQVIA Treatment in Participants >= 16 Years

    AUC0-tau;ss was defined as the area under the curve over one dosing interval at steady-state. The AUC0-tau;ss was calculated during the dosing interval after the last dose in each crossover epoch by the non-compartmental analysis (NCA) based on total IgG levels for TAK-881 and HYQVIA.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

Secondary outcomes

  1. Mean Annualized Rate of All Infections

    Mean annualized rates and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  2. Mean Annualized Rate of Acute Serious Bacterial Infections (ASBIs)

    Mean annualized rates of ASBIs and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  3. Mean Annualized Rate of Fever Episodes

    Mean annualized rates of fever episodes and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  4. Time to First ASBI

    The time to first ASBI was defined as the time between the first investigational product (IP) administration (referring to the first ramp-up dose, if ramp-up is applicable, or to the first full dose at Week 1, if ramp-up is not applicable) and the first occurrence of the ASBI. The median time to first ASBI was reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  5. Duration of Infections

    The median duration of infections was reported. Only participants with an infection are included here.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  6. Number of Days Not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or Their Treatment, or Other Illnesses

    The mean number of days with daily activity impairment per participant-year was reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  7. Number of Days on Antibiotics Due to Treatment of Infection

    Days on antibiotics were calculated as the total number of calendar days during which at least one respective antibiotic was administered due to treatment of infection. Data was collected for administration via oral or parenteral and all routes. The mean number of days on antibiotics per participant-year was reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  8. Number of Participants Hospitalized Due to Infection or Other Illnesses

    Number of participants hospitalized due to infection or other illnesses were reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  9. Number of Days of Hospitalization Due to Infections or Other Illnesses

    The number of days of hospitalization due to infection per participant-year was reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  10. Number of Participants With Acute Physician Visits Due to Infection or Other Illnesses

    Number of participants with acute physician visits due to infection or other illnesses was reported.

    Time frame: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks

  11. Maximum Concentration (Cmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    Cmax of total IgG with TAK-881 and HYQVIA at steady-state was reported.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  12. Time to Maximum Concentration (Tmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    Tmax of total IgG with TAK-881 and HYQVIA at steady-state was reported.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  13. Terminal Half-life (t1/2) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    t1/2 of total IgG with TAK-881 and HYQVIA at steady-state was reported. t1/2 was estimated by noncompartmental analysis from the terminal elimination-rate constant derived from the slope of the log-linear decline in total IgG concentrations during the terminal phase of the concentration-time profile. The estimated t1/2 may exceed the 21- or 28-day PK sampling interval. The PK assessment period did not extend beyond the protocol-defined 21-day or 28-day interval.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  14. Apparent Clearance (CL/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    CL/F of total IgG with TAK-881 and HYQVIA at steady-state was reported.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  15. Apparent Volume of Distribution (Vz/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    Vz/F of total IgG with TAK-881 and HYQVIA at steady-state was reported.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  16. AUC0-tau;ss Per Week (AUC0-tau;ss/Week) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

    AUC0-tau;ss/week of total IgG with TAK-881 and HYQVIA at steady-state was reported.

    Time frame: During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)

  17. Trough Level of Total IgG

    The trough level of total IgG was reported. Total IgG trough levels were analyzed using the last trough level per participants (at the end of the last dosing interval).

    Time frame: Single arm treatment: pre-infusion at Week 25 during the 4-week dosing; Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen

  18. Trough Level of IgG Subclasses

    The trough level of IgG subclasses was reported. Trough levels of IgG subclasses were analyzed using the last trough level per participants (at the end of the last dosing interval).

    Time frame: Single arm treatment: pre-infusion at Week 21 during the 4-week dosing; Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen

  19. Trough Level of Antigen Specific IgG Antibodies in Participants >=16 Years

    The trough level of antigen specific IgG antibodies (Clostridium tetani toxoid, Haemophilus influenzae, and hepatitis B) was reported. Antigen-specific IgG antibodies were analyzed using the last trough level per participant in each crossover epoch (at the end of the last dosing interval).

    Time frame: Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen

  20. Simulated AUC0-tau;ss of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. AUC0-tau;ss was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% predicted interval (PI) derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  21. Simulated Cmax of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Cmax was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  22. Simulated Tmax of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Tmax was estimated for the simulated PK profiles and summarized by age group. Median and full range derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  23. Simulated t1/2 of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. t1/2 was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  24. Simulated CL/F of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. CL/F was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  25. Simulated Vz/F of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Vz/F was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  26. Simulated AUC0-tau;ss/Week of TAK-881 at Steady-State

    Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. AUC0-tau;ss/week was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

    Time frame: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks

  27. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study subject, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

    Time frame: From the start of study drug administration, up to 27 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)

  28. Number of Participants With Infusion Withdrawals, Interruptions, or Infusion Rate Reductions Due to TAK-881-related TEAEs

    Number of participants with infusion withdrawals, interruptions, or infusion rate reductions due to TAK-881-related TEAEs were reported.

    Time frame: From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 48 weeks (Crossover treatment)

  29. Number of Participants With Positive Binding Antibodies (Titer Greater Than and Equal to [>=] 1:160) and Positive Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)

    Participants were considered "Positive" if corresponding titer is \>=1:160 and were considered "Negative" if no anti-drug antibodies (ADA) is quantified (negative assay result) or the corresponding titer is \<1:160.

    Time frame: From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)

  30. Number of Infusions Per Month at Full Dose With Both TAK-881 and HYQVIA

    Number of infusion per month at full dose was calculated as the total number of full dose infusions divided by the total time in months on treatment. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  31. Duration of Infusions Per Participant at Full Dose With Both TAK-881 and HYQVIA

    The sum of the following: 1) Stop time of rHuPH20 - start time of rHuPH20; 2) Sum of all individual IgG duration steps; 3) Start time of IgG - Stop time of rHuPH20, 4) Duration of all IgG interruptions independent of the reason for interruption. For each participant, the average infusion duration was calculated; participant-level averages were then summarized using median and full range.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  32. Monthly Infusion Time Per Participant at Full Dose With Both TAK-881 and HYQVIA

    Monthly infusion time per participant at full dose was calculated as the total duration of full dose infusions per treatment divided by the total time in months on the respective treatment. For each participant, the average monthly infusion time was calculated; participant-level averages were then summarized using median and full range.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  33. Number of Infusion Sites (Needle Sticks) Per Infusion at Full Dose With Both TAK-881 and HYQVIA

    Number of infusion sites per infusion at full dose was calculated as the total number of full dose infusion sites divided by the total number of full dose infusions with an available infusion site. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  34. Number of Infusion Sites (Needle Sticks) Per Month at Full Dose With Both TAK-881 and HYQVIA in All Participant

    Number of infusion sites per month at full dose was calculated as the total number of full dose infusion sites divided by the total time in months on treatment. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  35. Maximum Tolerated Infusion Rate Per Site at Full Dose With Both TAK-881 and HYQVIA

    The maximum tolerated infusion rate at full dose was reported for rHuPH20 and IgG.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

  36. Infusion Volume Per Site Per Participant at Full Dose With Both TAK-881 and HYQVIA

    Infusion volume per site at full dose was reported for rHuPH20 and IgG. Infusion volume was measured in milliliters (mL), and infusion volume per site was reported in terms of mL per site per participant. For each participant, the average infusion volume per site was calculated; participant-level averages were then summarized using median and full range.

    Time frame: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks

07

Results

Posted Sep 30, 2026

Participant flow

Participants with primary immunodeficiency diseases (PIDD) took part in the study across 26 investigative sites in Czech Republic, Denmark, Spain, Greece, Netherlands, Poland, Slovakia, and United States from 24 October 2023 to 20 January 2026. Participants previously treated with IGIV or HYQVIA maintained their prestudy 3- or 4-week dosing interval. For participants previously treated with conventional IGSC, the 3- or 4-week dosing interval was selected by the investigator at screening.

Treatment Period 1: Week 1 to Week 25
Participant flow — Treatment Period 1: Week 1 to Week 25
MilestoneSingle Arm Treatment: TAK-881 (2 to <16 Years)Sequence 1 (AB): TAK-881 Followed by HYQVIA (>=16 Years)Sequence 2 (BA): HYQVIA Followed by TAK-881 (>=16 Years)
Started222221
Completed221719
Not completed052
Withdrew: Withdrawal by subject012
Withdrew: Protocol violation030
Withdrew: Adverse event010
Treatment Period 2: Week 25 to Week 49
Participant flow — Treatment Period 2: Week 25 to Week 49
MilestoneSingle Arm Treatment: TAK-881 (2 to <16 Years)Sequence 1 (AB): TAK-881 Followed by HYQVIA (>=16 Years)Sequence 2 (BA): HYQVIA Followed by TAK-881 (>=16 Years)
Started01719
Completed01519
Not completed020
Withdrew: Adverse event010
Withdrew: Protocol violation010

Outcome measures

PrimaryArea Under the Curve Over One Dosing Interval at Steady-State (AUC0-tau;ss) of Total IgG Levels With TAK-881 and HYQVIA Treatment in Participants >= 16 Years

AUC0-tau;ss was defined as the area under the curve over one dosing interval at steady-state. The AUC0-tau;ss was calculated during the dosing interval after the last dose in each crossover epoch by the non-compartmental analysis (NCA) based on total IgG levels for TAK-881 and HYQVIA.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · days*gram per liter (day*g/L)
Area Under the Curve Over One Dosing Interval at Steady-State (AUC0-tau;ss) of Total IgG Levels With TAK-881 and HYQVIA Treatment in Participants >= 16 Years
days*gram per liter (day*g/L)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Area Under the Curve Over One Dosing Interval at Steady-State (AUC0-tau;ss) of Total IgG Levels With TAK-881 and HYQVIA Treatment in Participants >= 16 Years326 (296 to 359)327 (297 to 360)
Statistical analysis
  • Crossover Treatment: TAK-881 (>=16 Years) vs Crossover Treatment: HYQVIA (>= 16 Years) · Geometric mean ratio: 0.9967 · 90% CI 0.9510 to 1.0446
SecondaryMean Annualized Rate of All Infections

Mean annualized rates and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · infections per participant year
Mean Annualized Rate of All Infections
infections per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Mean Annualized Rate of All Infections5.37 (3.78 to 7.36)2.62 (1.75 to 3.76)2.73 (1.85 to 3.86)
SecondaryMean Annualized Rate of Acute Serious Bacterial Infections (ASBIs)

Mean annualized rates of ASBIs and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · ASBI per participant year
Mean Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
ASBI per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Mean Annualized Rate of Acute Serious Bacterial Infections (ASBIs)0.0926 (0.0259 to 0.227)0.0558 (0.0197 to 0.121)0 (0 to 0.214)
SecondaryMean Annualized Rate of Fever Episodes

Mean annualized rates of fever episodes and corresponding two-sided 95% CIs were reported for TAK-881 and HYQVIA and were analyzed using a generalized linear model. The response distribution was assumed to be Poisson with a logarithmic link function. The model included the natural logarithm of the length of the observational period in years as an offset to account for potential differences in lengths of the observational periods per participant. Results were back transformed from the logarithmic scale.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · fever episodes per participant year
Mean Annualized Rate of Fever Episodes
fever episodes per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Mean Annualized Rate of Fever Episodes1.76 (1.01 to 2.81)0.558 (0.287 to 0.964)0.232 (0.103 to 0.441)
SecondaryTime to First ASBI

The time to first ASBI was defined as the time between the first investigational product (IP) administration (referring to the first ramp-up dose, if ramp-up is applicable, or to the first full dose at Week 1, if ramp-up is not applicable) and the first occurrence of the ASBI. The median time to first ASBI was reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Median · days
Time to First ASBI
daysSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Time to First ASBI173.0 (173 to 173)56.0 (56 to 56)—
SecondaryDuration of Infections

The median duration of infections was reported. Only participants with an infection are included here.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Median · days
Duration of Infections
daysSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Duration of Infections9.0 (2 to 49)9.0 (1 to 56)9.0 (1 to 196)
SecondaryNumber of Days Not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or Their Treatment, or Other Illnesses

The mean number of days with daily activity impairment per participant-year was reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · days per participant year
Number of Days Not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or Their Treatment, or Other Illnesses
days per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Days Not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or Their Treatment, or Other Illnesses13.1 ± 25.5417.6 ± 58.5713.8 ± 34.49
SecondaryNumber of Days on Antibiotics Due to Treatment of Infection

Days on antibiotics were calculated as the total number of calendar days during which at least one respective antibiotic was administered due to treatment of infection. Data was collected for administration via oral or parenteral and all routes. The mean number of days on antibiotics per participant-year was reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · days per participant year
Number of Days on Antibiotics Due to Treatment of Infection
days per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Oral/ Parenteral Route13.8 ± 20.4019.7 ± 37.9116.3 ± 25.86
All Routes18.4 ± 25.6519.7 ± 37.9116.7 ± 26.83
SecondaryNumber of Participants Hospitalized Due to Infection or Other Illnesses

Number of participants hospitalized due to infection or other illnesses were reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Count of participants · Participants
Number of Participants Hospitalized Due to Infection or Other Illnesses
ParticipantsSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Participants Hospitalized Due to Infection or Other Illnesses311
SecondaryNumber of Days of Hospitalization Due to Infections or Other Illnesses

The number of days of hospitalization due to infection per participant-year was reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Mean · days per participant year
Number of Days of Hospitalization Due to Infections or Other Illnesses
days per participant yearSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Days of Hospitalization Due to Infections or Other Illnesses2.0 ± 6.641.8 ± 11.300.2 ± 1.05
SecondaryNumber of Participants With Acute Physician Visits Due to Infection or Other Illnesses

Number of participants with acute physician visits due to infection or other illnesses was reported.

Time frame:
Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Reported as:
Count of participants · Participants
Number of Participants With Acute Physician Visits Due to Infection or Other Illnesses
ParticipantsSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Participants With Acute Physician Visits Due to Infection or Other Illnesses161816
SecondaryMaximum Concentration (Cmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

Cmax of total IgG with TAK-881 and HYQVIA at steady-state was reported.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · gram per litre (g/L)
Maximum Concentration (Cmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
gram per litre (g/L)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Maximum Concentration (Cmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years15.9 (14.4 to 17.5)16.1 (14.6 to 17.8)
SecondaryTime to Maximum Concentration (Tmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

Tmax of total IgG with TAK-881 and HYQVIA at steady-state was reported.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Median · days
Time to Maximum Concentration (Tmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
daysCrossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Time to Maximum Concentration (Tmax) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years6.81 (0.91 to 13.90)3.07 (1.13 to 21.93)
SecondaryTerminal Half-life (t1/2) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

t1/2 of total IgG with TAK-881 and HYQVIA at steady-state was reported. t1/2 was estimated by noncompartmental analysis from the terminal elimination-rate constant derived from the slope of the log-linear decline in total IgG concentrations during the terminal phase of the concentration-time profile. The estimated t1/2 may exceed the 21- or 28-day PK sampling interval. The PK assessment period did not extend beyond the protocol-defined 21-day or 28-day interval.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · days
Terminal Half-life (t1/2) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
daysCrossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Terminal Half-life (t1/2) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years70.8 (43.3 to 116)58.5 (35.8 to 95.6)
SecondaryApparent Clearance (CL/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

CL/F of total IgG with TAK-881 and HYQVIA at steady-state was reported.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · milliliters per day (mL/day)
Apparent Clearance (CL/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
milliliters per day (mL/day)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Apparent Clearance (CL/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years123 (106 to 144)125 (108 to 146)
SecondaryApparent Volume of Distribution (Vz/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

Vz/F of total IgG with TAK-881 and HYQVIA at steady-state was reported.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · milliliters (mL)
Apparent Volume of Distribution (Vz/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
milliliters (mL)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Apparent Volume of Distribution (Vz/F) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years9340 (6000 to 14500)8070 (5180 to 12600)
SecondaryAUC0-tau;ss Per Week (AUC0-tau;ss/Week) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years

AUC0-tau;ss/week of total IgG with TAK-881 and HYQVIA at steady-state was reported.

Time frame:
During the dosing interval of 8th dose (3-week) or 6th dose (4-week): 3-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21 days (post-infusion); 4-week dosing - Day 1 (pre & post-infusion), 24,48,72 hours, 7,14,21,28 days (post-infusion)
Reported as:
Geometric mean · day*g/L/week
AUC0-tau;ss Per Week (AUC0-tau;ss/Week) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years
day*g/L/weekCrossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
AUC0-tau;ss Per Week (AUC0-tau;ss/Week) of Total IgG With TAK-881 and HYQVIA at Steady-State in Participants >=16 Years94.1 (85.4 to 104)94.4 (85.7 to 104)
SecondaryTrough Level of Total IgG

The trough level of total IgG was reported. Total IgG trough levels were analyzed using the last trough level per participants (at the end of the last dosing interval).

Time frame:
Single arm treatment: pre-infusion at Week 25 during the 4-week dosing; Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen
Reported as:
Geometric mean · g/L
Trough Level of Total IgG
g/LSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Trough Level of Total IgG9.25 (7.86 to 10.9)11.7 (10.4 to 13.1)11.9 (10.6 to 13.4)
SecondaryTrough Level of IgG Subclasses

The trough level of IgG subclasses was reported. Trough levels of IgG subclasses were analyzed using the last trough level per participants (at the end of the last dosing interval).

Time frame:
Single arm treatment: pre-infusion at Week 21 during the 4-week dosing; Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen
Reported as:
Geometric mean · g/L
Trough Level of IgG Subclasses
g/LSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
IgG15.07 (4.35 to 5.91)6.59 (5.91 to 7.34)6.62 (5.94 to 7.38)
IgG22.95 (2.65 to 3.29)3.71 (3.30 to 4.17)3.72 (3.31 to 4.17)
IgG30.198 (0.165 to 0.238)0.270 (0.230 to 0.317)0.274 (0.233 to 0.321)
IgG40.271 (0.197 to 0.372)0.373 (0.277 to 0.504)0.396 (0.294 to 0.535)
SecondaryTrough Level of Antigen Specific IgG Antibodies in Participants >=16 Years

The trough level of antigen specific IgG antibodies (Clostridium tetani toxoid, Haemophilus influenzae, and hepatitis B) was reported. Antigen-specific IgG antibodies were analyzed using the last trough level per participant in each crossover epoch (at the end of the last dosing interval).

Time frame:
Crossover treatment: pre-infusion at Weeks 25, 49, corresponding to 21 days after the last dose for 3-week dosing and 28 days after the last dose for 4-week regimen
Reported as:
Geometric mean · international units/ milliliter (IU/mL)
Trough Level of Antigen Specific IgG Antibodies in Participants >=16 Years
international units/ milliliter (IU/mL)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Antibodies to Clostridium Tetani Toxoid1.84 (1.51 to 2.24)1.65 (1.35 to 2.01)
Antibodies to Haemophilus Influenzae1.60 (1.23 to 2.07)1.73 (1.33 to 2.24)
SecondarySimulated AUC0-tau;ss of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. AUC0-tau;ss was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% predicted interval (PI) derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · g*day/L
Simulated AUC0-tau;ss of TAK-881 at Steady-State
g*day/LPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated AUC0-tau;ss of TAK-881 at Steady-State270 (210 to 386)306 (227 to 460)
SecondarySimulated Cmax of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Cmax was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · g/L
Simulated Cmax of TAK-881 at Steady-State
g/LPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated Cmax of TAK-881 at Steady-State11.2 (8.83 to 15.4)12.5 (9.48 to 18.1)
SecondarySimulated Tmax of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Tmax was estimated for the simulated PK profiles and summarized by age group. Median and full range derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Median · days
Simulated Tmax of TAK-881 at Steady-State
daysPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated Tmax of TAK-881 at Steady-State4.00 (2.00 to 5.00)4.00 (2.00 to 5.00)
SecondarySimulated t1/2 of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. t1/2 was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · days
Simulated t1/2 of TAK-881 at Steady-State
daysPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated t1/2 of TAK-881 at Steady-State81.3 (50.2 to 143)73.4 (47.3 to 127)
SecondarySimulated CL/F of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. CL/F was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · milliliter/ day/ kilogram (mL/day/kg)
Simulated CL/F of TAK-881 at Steady-State
milliliter/ day/ kilogram (mL/day/kg)Population PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated CL/F of TAK-881 at Steady-State1.84 (1.29 to 2.37)1.62 (1.08 to 2.18)
SecondarySimulated Vz/F of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. Vz/F was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · L/kg
Simulated Vz/F of TAK-881 at Steady-State
L/kgPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated Vz/F of TAK-881 at Steady-State0.0466 (0.0311 to 0.0667)0.0402 (0.0261 to 0.0581)
SecondarySimulated AUC0-tau;ss/Week of TAK-881 at Steady-State

Sparse PK sampling was conducted for participants aged 2 to \<16 years. A population PK model integrating PK data from participants aged 2 to \<16 years and participants aged \>=16 years was developed. Population PK simulations were performed using virtual pediatric and adult populations constructed from age- and sex-specific body weight distributions, ensuring that the simulations were representative of the target PIDD population. AUC0-tau;ss/week was estimated for the simulated PK profiles and summarized by age group. Geometric mean and 90% PI derived from the simulation (N = 3000 per age group) at the observed median of average body weight adjusted TAK-881 full-dose per participant for every-4-week dosing frequency were reported.

Time frame:
During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
Reported as:
Geometric mean · day*g/L/week
Simulated AUC0-tau;ss/Week of TAK-881 at Steady-State
day*g/L/weekPopulation PK: TAK-881 (2 to <16 Years)Population PK: TAK-881 (>=16 Years)
Simulated AUC0-tau;ss/Week of TAK-881 at Steady-State67.5 (52.4 to 96.5)76.4 (56.8 to 115)
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical study subject, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Time frame:
From the start of study drug administration, up to 27 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)223335
SecondaryNumber of Participants With Infusion Withdrawals, Interruptions, or Infusion Rate Reductions Due to TAK-881-related TEAEs

Number of participants with infusion withdrawals, interruptions, or infusion rate reductions due to TAK-881-related TEAEs were reported.

Time frame:
From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 48 weeks (Crossover treatment)
Reported as:
Count of participants · Participants
Number of Participants With Infusion Withdrawals, Interruptions, or Infusion Rate Reductions Due to TAK-881-related TEAEs
ParticipantsSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Infusion Rate Reduction711
Infusion Interruption631
Infusion Withdrawal000
SecondaryNumber of Participants With Positive Binding Antibodies (Titer Greater Than and Equal to [>=] 1:160) and Positive Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)

Participants were considered "Positive" if corresponding titer is \>=1:160 and were considered "Negative" if no anti-drug antibodies (ADA) is quantified (negative assay result) or the corresponding titer is \<1:160.

Time frame:
From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)
Reported as:
Count of participants · Participants
Number of Participants With Positive Binding Antibodies (Titer Greater Than and Equal to [>=] 1:160) and Positive Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
ParticipantsSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881/HYQVIA and HYQVIA/TAK-881 (>=16 Years)
Positive Binding Antibodies04
Positive Neutralizing Antibodies00
SecondaryNumber of Infusions Per Month at Full Dose With Both TAK-881 and HYQVIA

Number of infusion per month at full dose was calculated as the total number of full dose infusions divided by the total time in months on treatment. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Number · infusion per month
Number of Infusions Per Month at Full Dose With Both TAK-881 and HYQVIA
infusion per monthSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Infusions Per Month at Full Dose With Both TAK-881 and HYQVIA1.081.211.21
SecondaryDuration of Infusions Per Participant at Full Dose With Both TAK-881 and HYQVIA

The sum of the following: 1) Stop time of rHuPH20 - start time of rHuPH20; 2) Sum of all individual IgG duration steps; 3) Start time of IgG - Stop time of rHuPH20, 4) Duration of all IgG interruptions independent of the reason for interruption. For each participant, the average infusion duration was calculated; participant-level averages were then summarized using median and full range.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Median · minutes per participant
Duration of Infusions Per Participant at Full Dose With Both TAK-881 and HYQVIA
minutes per participantSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Duration of Infusions Per Participant at Full Dose With Both TAK-881 and HYQVIA66.8 (34.3 to 135)66.9 (30.7 to 121)95.1 (63.7 to 234)
SecondaryMonthly Infusion Time Per Participant at Full Dose With Both TAK-881 and HYQVIA

Monthly infusion time per participant at full dose was calculated as the total duration of full dose infusions per treatment divided by the total time in months on the respective treatment. For each participant, the average monthly infusion time was calculated; participant-level averages were then summarized using median and full range.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Median · minutes per month per participant
Monthly Infusion Time Per Participant at Full Dose With Both TAK-881 and HYQVIA
minutes per month per participantSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Monthly Infusion Time Per Participant at Full Dose With Both TAK-881 and HYQVIA72.4 (36.2 to 150)80.1 (32.9 to 492)115 (69.6 to 570)
SecondaryNumber of Infusion Sites (Needle Sticks) Per Infusion at Full Dose With Both TAK-881 and HYQVIA

Number of infusion sites per infusion at full dose was calculated as the total number of full dose infusion sites divided by the total number of full dose infusions with an available infusion site. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Number · number of sites per infusion
Number of Infusion Sites (Needle Sticks) Per Infusion at Full Dose With Both TAK-881 and HYQVIA
number of sites per infusionSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Infusion Sites (Needle Sticks) Per Infusion at Full Dose With Both TAK-881 and HYQVIA1.231.471.64
SecondaryNumber of Infusion Sites (Needle Sticks) Per Month at Full Dose With Both TAK-881 and HYQVIA in All Participant

Number of infusion sites per month at full dose was calculated as the total number of full dose infusion sites divided by the total time in months on treatment. A single aggregate value was therefore presented; a measure of dispersion was not applicable.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Number · number of sites per month
Number of Infusion Sites (Needle Sticks) Per Month at Full Dose With Both TAK-881 and HYQVIA in All Participant
number of sites per monthSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
Number of Infusion Sites (Needle Sticks) Per Month at Full Dose With Both TAK-881 and HYQVIA in All Participant1.331.771.98
SecondaryMaximum Tolerated Infusion Rate Per Site at Full Dose With Both TAK-881 and HYQVIA

The maximum tolerated infusion rate at full dose was reported for rHuPH20 and IgG.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Median · milliliter/ hour/ site (mL/hour/site)
Maximum Tolerated Infusion Rate Per Site at Full Dose With Both TAK-881 and HYQVIA
milliliter/ hour/ site (mL/hour/site)Single Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
rHuPH20120.0 (30 to 120)120.0 (30 to 300)120.0 (60 to 120)
IgG120.0 (40 to 300)300.0 (120 to 300)300.0 (5 to 300)
SecondaryInfusion Volume Per Site Per Participant at Full Dose With Both TAK-881 and HYQVIA

Infusion volume per site at full dose was reported for rHuPH20 and IgG. Infusion volume was measured in milliliters (mL), and infusion volume per site was reported in terms of mL per site per participant. For each participant, the average infusion volume per site was calculated; participant-level averages were then summarized using median and full range.

Time frame:
Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Reported as:
Median · mL per site per participant
Infusion Volume Per Site Per Participant at Full Dose With Both TAK-881 and HYQVIA
mL per site per participantSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>= 16 Years)
rHuPH206.25 (2.00 to 13.0)13.9 (7.50 to 30.3)12.5 (7.50 to 28.0)
IgG62.8 (19.3 to 125)138 (75.0 to 298)250 (88.1 to 550)

Adverse events

Collected over From the start of study drug administration, up to 27 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single Arm Treatment: TAK-881 (2 to <16 Years)0/22 (0%)3/22 (13.6%)21/22 (95.5%)
Crossover Treatment: TAK-881 (>=16 Years)0/41 (0%)1/41 (2.4%)31/41 (75.6%)
Crossover Treatment: HYQVIA (>=16 Years)0/38 (0%)3/38 (7.9%)31/38 (81.6%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>=16 Years)
Gastritis viralInfections and infestations1/220/410/38
InfluenzaInfections and infestations1/220/410/38
Pneumonia aspirationInfections and infestations1/220/410/38
AtaxiaNervous system disorders0/220/411/38
Chest discomfortGeneral disorders0/220/411/38
HeadacheNervous system disorders0/220/411/38
Postoperative wound infectionInfections and infestations0/220/411/38
SyncopeNervous system disorders0/220/411/38
Vision blurredEye disorders0/220/411/38
COVID-19Infections and infestations0/221/410/38
Most frequent other events
Showing 10 of 42
Most frequent other events
EventSingle Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881 (>=16 Years)Crossover Treatment: HYQVIA (>=16 Years)
Infusion site erythemaGeneral disorders13/2213/4110/38
HeadacheNervous system disorders10/2211/418/38
Infusion site painGeneral disorders9/228/416/38
Upper respiratory tract infectionInfections and infestations6/227/414/38
CoughRespiratory, thoracic and mediastinal disorders5/220/413/38
Infusion site extravasationGeneral disorders5/223/411/38
Infusion site pruritusGeneral disorders5/223/415/38
SinusitisInfections and infestations5/222/412/38
FatigueGeneral disorders2/226/418/38
COVID-19Infections and infestations2/222/417/38

Baseline characteristics

The safety analysis set (SAS) included all participants who received any amount of TAK-881 or HYQVIA. As pre-specified in the statistical analysis plan (SAP), baseline characteristics data were summarized by age group.

Age, Continuous
Age, Continuous(years)Single Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881/HYQVIA and HYQVIA/TAK-881 (>=16 Years)Total
Mean8.2 ± 4.2452.2 ± 18.2337.3 ± 25.76
Sex: Female, Male
Sex: Female, Male(Participants)Single Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881/HYQVIA and HYQVIA/TAK-881 (>=16 Years)Total
Female92433
Male131932
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Single Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881/HYQVIA and HYQVIA/TAK-881 (>=16 Years)Total
Hispanic or Latino112
Not Hispanic or Latino214263
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Single Arm Treatment: TAK-881 (2 to <16 Years)Crossover Treatment: TAK-881/HYQVIA and HYQVIA/TAK-881 (>=16 Years)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White224163
More than one race011
Unknown or Not Reported011
08

Study locations

32 sites
  • University of California Irvine Medical Center
    Irvine, California 92697, United States
  • Allergy and Asthma Clinical Research
    Walnut Creek, California 94598, United States
  • National Jewish Medical And Research Center
    Denver, Colorado 80206, United States
  • University of South Florida
    St. Petersburg, Florida 33701, United States
  • Central Georgia Infectious Disease Consultants
    Macon, Georgia 31201, United States
  • Rush University Medical Center - University Cardiovascular Surgeons
    Chicago, Illinois 60612-3852, United States
  • Sneeze, Wheeze, & Itch Associates, LLC
    Normal, Illinois 61761, United States
  • Louisiana State University Health Science Center-New Orleans
    New Orleans, Louisiana 70118, United States
  • Northwell Health
    Great Neck, New York 11021, United States
  • Montefiore Medical Center
    The Bronx, New York 10461, United States
  • Duke Asthma, Allergy and Airway Center
    Durham, North Carolina 27705, United States
  • Optimed Research, LTD
    Columbus, Ohio 43235, United States
  • Vital Prospects Clinical Research Institute, PC
    Tulsa, Oklahoma 74136, United States
  • Allergy Partners of North Texas
    Dallas, Texas 75230, United States
  • Tanner Clinic
    Murray, Utah 84107, United States
  • University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)
    Brno, 62500, Czechia
  • Fakultni nemocnice u sv. Anny v Brne - ICRC
    Brno, 656 91, Czechia
  • Fakultni Nemocnice v Motole
    Prague, 14300, Czechia
  • Aarhus Universitetshospital
    Aarhus, 8200, Denmark
  • Odense University Hospital
    Odense, 5000, Denmark
  • University Hospital Carl Gustav Carus
    Dresden, 01307, Germany
  • Universitaetsklinikum Tuebingen (UKT)
    Tübingen, 72076, Germany
  • Universitair Medisch Centrum Utrecht (UMC Utrecht)
    Utrecht, 3584 CX, Netherlands
  • Instytut Pomnik - Centrum Zdrowia Dziecka
    Warsaw, Masovian Voivodeship 00-999, Poland
  • Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
    Warsaw, Masovian Voivodeship 04-141, Poland
  • Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII
    Gdansk, Pomeranian Voivodeship 80-952, Poland
  • Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi
    Lodz, 90329, Poland
  • NUDCH (National Institute of Children's Diseases)
    Bratislava, 833 40, Slovakia
  • OKIA, s.r.o
    Košice, 040 01, Slovakia
  • Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin
    Martin, 036 01, Slovakia
  • Hospital Sant Joan de Deu Barcelona
    Esplugues de Llobregat, Barcelona 08950, Spain
  • University Hospital La Paz
    Madrid, 28046, Spain
09

References and documents

Study documents

  • Study protocol · Jul 29, 2024
  • Statistical analysis plan · Nov 19, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Sep 30, 2026
Also revised
primary outcomes
Show all 1 update
  1. Sep 30, 2026
    Results posted
    Primary outcomes Revised (2 changes)
    + 4 other changes: verification date, secondary outcomes, index terms and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05755035
Lead sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
Responsible party
Sponsor
First posted
Mar 6, 2023
Start date
Oct 24, 2023
Primary completion
Jan 20, 2026
Completion
Jan 20, 2026
Results posted
Sep 30, 2026
Last update
Sep 30, 2026

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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