New shot option for immune deficiency shows promise in early trial

NCT ID NCT05755035

Completed 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.

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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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