New shot option for immune deficiency shows promise in early trial

NCT ID NCT05755035

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new medicine called TAK-881, a concentrated antibody solution given under the skin, in 65 people with primary immunodeficiency diseases (PIDD). The goal was to see how well the body absorbs it and if it is safe compared to an existing treatment (HYQVIA). Participants received either TAK-881 or HYQVIA for up to 51 weeks, with regular clinic visits every 3-4 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TAK-881 (immune globulin with hyaluronidase)
What this could lead to: If successful, TAK-881 could offer a new option for people with primary immunodeficiency to receive antibody replacement therapy under the skin.
What could go wrong: This is a mid-stage trial with only 65 participants, so results may not apply to everyone. As with any immunoglobulin product, there is a risk of allergic reactions or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

65 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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.

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Conditions

The condition(s) this trial relates to.

inborn error of immunity Primary Immunodeficiency Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immunodeficiency diseases (PID)

Contacts and locations

Locations

Aarhus Universitetshospital

Aarhus, 8200, Denmark
Allergy Partners of North Texas

Dallas, Texas, 75230, United States
Allergy and Asthma Clinical Research

Walnut Creek, California, 94598, United States
Central Georgia Infectious Disease Consultants

Macon, Georgia, 31201, United States
Duke Asthma, Allergy and Airway Center

Durham, North Carolina, 27705, United States
Fakultni Nemocnice v Motole

Prague, 14300, Czechia
Fakultni nemocnice u sv. Anny v Brne - ICRC

Brno, 656 91, Czechia
Hospital Sant Joan de Deu Barcelona

Esplugues de Llobregat, Barcelona, 08950, Spain
Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, 00-999, Poland
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin

Martin, 036 01, Slovakia
Louisiana State University Health Science Center-New Orleans

New Orleans, Louisiana, 70118, United States
Montefiore Medical Center

The Bronx, New York, 10461, United States
NUDCH (National Institute of Children's Diseases)

Bratislava, 833 40, Slovakia
National Jewish Medical And Research Center

Denver, Colorado, 80206, United States
Northwell Health

Great Neck, New York, 11021, United States
OKIA, s.r.o

Košice, 040 01, Slovakia
Odense University Hospital

Odense, 5000, Denmark
Optimed Research, LTD

Columbus, Ohio, 43235, United States
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi

Lodz, 90329, Poland
Rush University Medical Center - University Cardiovascular Surgeons

Chicago, Illinois, 60612-3852, United States
Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States
Tanner Clinic

Murray, Utah, 84107, United States
Universitaetsklinikum Tuebingen (UKT)

Tübingen, 72076, Germany
Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, 3584 CX, Netherlands
University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)

Brno, 62500, Czechia
University Hospital Carl Gustav Carus

Dresden, 01307, Germany
University Hospital La Paz

Madrid, 28046, Spain
University of California Irvine Medical Center

Irvine, California, 92697, United States
University of South Florida

St. Petersburg, Florida, 33701, United States
Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII

Gdansk, Pomeranian Voivodeship, 80-952, Poland
Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

Warsaw, Masovian Voivodeship, 04-141, Poland

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