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

NCT05755035 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: TAK-881-30012022-502095-23-01
• Study Type: interventional
• Target: 65
• Locations: 8 countries
• Sites: 32

Brief 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.

Conditions

Primary Immunodeficiency Diseases (PID)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) of total IgG with TAK-881 and HYQVIA in Participants Aged >=16 Years with PIDD

  3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch

Secondary Outcomes (35)

• Annualized Rate of all Infections in Participants

  Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)

• Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants

  Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)

• Annualized Rate of Episodes of Fever in Participants

  Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)

• Time to First ASBI in Participants

  Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)

• Duration of Infections in Participants

  Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)

Study Arms (3)

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).

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).

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).

Biological: TAK-881

Interventions

TAK-881 BIOLOGICAL

Participants will receive SC infusion of TAK-881.

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

Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2); Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1); Single Arm Treatment Epoch: TAK-881

HYQVIA BIOLOGICAL

Participants will receive SC infusion of HYQVIA.

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

Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2); Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (32)

University of California Irvine Medical Center

Irvine, California, 92697, United States

Location

Allergy and Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

National Jewish Medical And Research Center

Denver, Colorado, 80206, United States

Location

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

Central Georgia Infectious Disease Consultants

Macon, Georgia, 31201, United States

Location

Rush University Medical Center - University Cardiovascular Surgeons

Chicago, Illinois, 60612-3852, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Louisiana State University Health Science Center-New Orleans

New Orleans, Louisiana, 70118, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Duke Asthma, Allergy and Airway Center

Durham, North Carolina, 27705, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Allergy Partners of North Texas

Dallas, Texas, 75230, United States

Location

Tanner Clinic

Murray, Utah, 84107, United States

Location

University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)

Brno, 62500, Czechia

Location

Fakultni nemocnice u sv. Anny v Brne - ICRC

Brno, 656 91, Czechia

Location

Fakultni Nemocnice v Motole

Prague, 14300, Czechia

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitaetsklinikum Tuebingen (UKT)

Tübingen, 72076, Germany

Location

Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, 3584 CX, Netherlands

Location

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, 00-999, Poland

Location

Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi

Lodz, 90329, Poland

Location

NUDCH (National Institute of Children's Diseases)

Bratislava, 833 40, Slovakia

Location

OKIA, s.r.o

Košice, 040 01, Slovakia

Location

Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin

Martin, 036 01, Slovakia

Location

Hospital Sant Joan de Deu Barcelona

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

University Hospital La Paz

Madrid, 28046, Spain

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins; Solutions

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consists of crossover randomized epoch (participants aged \>=16 years) and single arm epoch (participants aged 2 to \<16 years).

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 6, 2023
• Study Start: October 24, 2023
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

NL (1); ES (2); CZ (3); DE (2); DK (2); US (15); SL (3); PL (4)