BridgeMD
Multicenter, Prospective, Open-label, Randomized, Crossover Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of TAK-881 in Primary Immunodeficiency Diseases (PIDD)
EU CTIS ID: 2022-502095-23-01
What this study is testing
To demonstrate PK comparability of TAK-881 and HYQVIA at steady-state after subcutaneous (SC) administration in subjects aged ≥16 years with PIDD.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject 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 (Bousfiha et al., 2020, Tangye et al., 2021).
- Subject is 2 years to <16 years at the time of signing the 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.
- Subject 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 g/kg BW/4 weeks and a maximum dose equivalent to 1 g/kg BW/4 weeks. Over that period, the subject should have been on the same product of IGIV, HYQVIA, or cIGSC. A stable dose is defined as one that deviates less than ±25% 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 subjects with a 28-day treatment interval and of up to ±3 days for subjects with a 7, 14, or 21-day treatment interval are acceptable up to the first IP infusion.
- Subject has a serum trough level of IgG >5 g/L at the following time points: a. At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and b. Within 12 weeks prior to screening.
- If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ a highly effective form of contraception for the duration of the study.
- Subject 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.
You likely can't join if
- Subject 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 subjects with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
- Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
- Subject has a bleeding disorder or a platelet count less than 20,000/µL, or, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of 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.
See the full eligibility criteria
Who can join
- Subject 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 (Bousfiha et al., 2020, Tangye et al., 2021).
- Subject is 2 years to <16 years at the time of signing the 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.
- Subject 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 g/kg BW/4 weeks and a maximum dose equivalent to 1 g/kg BW/4 weeks. Over that period, the subject should have been on the same product of IGIV, HYQVIA, or cIGSC. A stable dose is defined as one that deviates less than ±25% 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 subjects with a 28-day treatment interval and of up to ±3 days for subjects with a 7, 14, or 21-day treatment interval are acceptable up to the first IP infusion.
- Subject has a serum trough level of IgG >5 g/L at the following time points: a. At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and b. Within 12 weeks prior to screening.
- If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ a highly effective form of contraception for the duration of the study.
- Subject 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.
- The subject 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 subject 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.
What rules you out
- Subject 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 subjects with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
- Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
- Subject has a bleeding disorder or a platelet count less than 20,000/µL, or, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of 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.
- Subject has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator.
- Subject 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 subject at undue medical risk.
- Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening.
- Subject is scheduled to participate in another clinical study involving an IP (except for subjects scheduled to enroll in a long-term follow-up study with TAK-881) or investigational device during the course of this study.
- Subject is a family member or employee of the investigator or the investigator’s site staff.
- Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): a. Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5× the upper limit of normal (ULN) for the testing laboratory. b. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm3).
- If female, subject is pregnant or lactating at the time of screening.
- Known history of chronic kidney disease, or estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening.
- Subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator.
- Subject 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.
- Subjects with a known systemic hypersensitivity to any of the excipients of TAK 881/HYQVIA in accordance with the IB/package insert/Summary of Product Characteristics (SmPC).
- Known substance or prescription drug abuse within 12 months of screening.
- Subject has immunoglobulin A (IgA) deficiency (IgA less than 0.07 g/L) associated with known anti-IgA antibodies and a history of hypersensitivity.
- Subject has a known systemic hypersensitivity to hyaluronidase or rHuPH20.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.