Primary Immunodeficiency Diseases (PID)Phase 2/3NCT05755035
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
A Phase 2/3 study testing TAK-881 and HYQVIA in people with Primary Immunodeficiency Diseases (PID), run by Takeda at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- TAK-881 and HYQVIA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 24 Oct 2023to 20 Jan 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and
- Within 12 weeks prior to screening.
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- 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.
Who cannot join
- 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):
- Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5* the upper limit of normal (ULN) for the testing laboratory.
- 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.
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- 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.
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States15 sites
Rush University Medical Center - University Cardiovascular Surgeons
Chicago, Illinois, 60612-3852
Optimed Research, LTD
Columbus, Ohio, 43235
Allergy Partners of North Texas
Dallas, Texas, 75230
National Jewish Medical And Research Center
Denver, Colorado, 80206
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, 27705
Northwell Health
Great Neck, New York, 11021
University of California Irvine Medical Center
Irvine, California, 92697
Central Georgia Infectious Disease Consultants
Macon, Georgia, 31201
Tanner Clinic
Murray, Utah, 84107
Louisiana State University Health Science Center-New Orleans
New Orleans, Louisiana, 70118
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
University of South Florida
St. Petersburg, Florida, 33701
Montefiore Medical Center
The Bronx, New York, 10461
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
Allergy and Asthma Clinical Research
Walnut Creek, California, 94598
Poland4 sites
Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII
Gdansk, Pomeranian Voivodeship, 80-952
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi
Lodz, 90329
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, 00-999
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
Warsaw, Masovian Voivodeship, 04-141
Czechia3 sites
University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)
Brno, 62500
Fakultni nemocnice u sv. Anny v Brne - ICRC
Brno, 656 91
Fakultni Nemocnice v Motole
Prague, 14300
Slovakia3 sites
NUDCH (National Institute of Children's Diseases)
Bratislava, 833 40
OKIA, s.r.o
Košice, 040 01
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin
Martin, 036 01
Denmark2 sites
Aarhus Universitetshospital
Aarhus, 8200
Odense University Hospital
Odense, 5000
Germany2 sites
University Hospital Carl Gustav Carus
Dresden, 01307
Universitaetsklinikum Tuebingen (UKT)
Tübingen, 72076
Spain2 sites
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Barcelona, 08950
University Hospital La Paz
Madrid, 28046
Netherlands1 site
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
About this study
Official title: Multicenter, Prospective, Open-label, Randomized, Crossover Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of TAK-881 in Primary Immunodeficiency Diseases (PIDD)
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).
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- TAK-881, HYQVIA
- Keywords
- Immunoglobulin replacement therapy; facilitated subcutaneous, Immunoglobulin; primary immunodeficiency disease
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-881Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).
Participants will receive SC infusion of TAK-881.
HYQVIABiological
Also called Immune Globulin Infusion (Human), 10% Solution with rHuPH20.
Participants will receive SC infusion of HYQVIA.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1) | Experimental | 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). Receives: Biological: TAK-881; Biological: HYQVIA |
| Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2) | Experimental | 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). Receives: Biological: TAK-881; Biological: HYQVIA |
| Single Arm Treatment Epoch: TAK-881 | Experimental | 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). Receives: Biological: TAK-881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (36)
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Duration of Infections
The median duration of infections was reported. Only participants with an infection are included here.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
Number of Participants Hospitalized Due to Infection or Other Illnesses
Number of participants hospitalized due to infection or other illnesses were reported.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: Single arm treatment: Up to 27 weeks; Crossover treatment: Up to 51 weeks
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: During the dosing interval of 6th dose (4-week): From Day 1 (pre and post infusion) every day up to 4 weeks
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.
Measured: From the start of study drug administration, up to 27 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)
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.
Measured: From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 48 weeks (Crossover treatment)
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.
Measured: From the start of study drug administration, up to 23 weeks (Single arm treatment) and up to 51 weeks (Crossover treatment)
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
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.
Measured: Single arm treatment: Up to 20 weeks; Crossover treatment: Up to 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start24 Oct 2023
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study consists of crossover randomized epoch (participants aged \>=16 years) and single arm epoch (participants aged 2 to \<16 years).
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755035
- Sponsor's protocol ID
- TAK-881-3001
- Other IDs
- 2022-502095-23-01
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2023
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.