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New shot could help Immune-Compromised patients fight infections

NCT ID NCT04640142

Ongoing Disease control Sponsor: Octapharma Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 6 times

Summary

This phase 3 trial is testing a new medicine called Newnorm, a concentrated antibody solution given as a shot under the skin, in 50 people with primary immunodeficiency (a condition where the immune system doesn't work properly). The goal is to see if Newnorm can prevent serious bacterial infections and maintain protective antibody levels. Participants receive regular injections over the study period, and researchers track infection rates and side effects.

What this could mean

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

Active substance
Newnorm (a 20% human immunoglobulin solution injected under the skin)
What this could lead to
If successful, this could provide a new, convenient option for people with primary immunodeficiency to receive regular antibody replacement therapy at home, reducing infection risk.
What could go wrong
This is a single-arm, open-label study with only 50 participants, so results may not apply broadly. Side effects like local reactions or allergic responses are possible.

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 IMMUNE DEFICIENCY

Contacts and locations

Locations

  • Octapharma Research Site

    Irvine, California, 92697, United States

  • Octapharma Research Site

    Centennial, Colorado, 80112, United States

  • Octapharma Research Site

    Port Saint Lucie, Florida, 34986, United States

  • Octapharma Research Site

    St. Petersburg, Florida, 33701, United States

  • Octapharma Research Site

    Chicago, Illinois, 60612, United States

  • Octapharma Research Site

    Overland Park, Kansas, 66211, United States

  • Octapharma Research Site

    Louisville, Kentucky, 40217, United States

  • Octapharma Research Site

    White Marsh, Maryland, 21162, United States

  • Octapharma Research Site

    Kansas City, Missouri, 64111, United States

  • Octapharma Research Site

    Omaha, Nebraska, 68046, United States

  • Octapharma Research Site

    Leipzig, 04129, Germany

  • Octapharma Research Site

    Munich, 80337, Germany

  • Octapharma Research Site

    Budapest, 1097, Hungary

  • Octapharma Research Site

    Debrecen, 4032, Hungary

  • Octapharma Research Site

    Naples, 80131, Italy

  • Octapharma Research Site

    Roma, 00161, Italy

  • Octapharma Research Site

    Roma, 133, Italy

  • Octapharma Research Site

    Treviso, 31100, Italy

  • Octapharma Research Site

    Krakow, 30-663, Poland

  • Octapharma Research Site

    Bratislava, 833 40, Slovakia

  • Octapharma Research Site

    Kyiv, 04209, Ukraine

  • Octapharma Research Site

    Lviv, 79010, Ukraine

  • Octapharma Research Site

    Lviv, 79035, Ukraine

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