New immune boost for rare immune disorder? small trial underway
NCT ID NCT07076446
First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This study tests a drug called IgPro20, a type of immune globulin given under the skin, in adults with primary immunodeficiency who have never received such treatment. The goal is to see how the drug moves through the body and whether it is safe. Only 8 participants are enrolled, making this a very early look at the therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IgPro20 (immune globulin subcutaneous, 20% liquid)
- What this could lead to
- If successful, this could provide a new treatment option for people with primary immunodeficiency who have not previously received immune globulin therapy.
- What could go wrong
- This is a very small, early-phase study with only 8 participants, so results may not apply to everyone. Side effects like infusion reactions or infections are possible.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
8 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Jun 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
-
18 years and older
- Sex
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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 Hide 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: * Participants must be aged \>=18 years. * Participants must have a confirmed and documented diagnosis of PID, must be IG treatment-naïve and have an IgG level less than or equal to (\<=) 400 milligrams per deciliter(mg/dL) at Screening. Exclusion Criteria: * Participants with hyperprolinemia. * Participants who are receiving the following medications: * Systemic corticosteroids (prednisone or equivalent; average daily dose of greater than \[\>\] 15 mg) from 4 weeks before Screening. * Any dose of systemic immunosuppressants within 9 months or 5 times the half-life (t½) plus 6 months before Screening, whichever is longer. * Any dose of biologic therapies with influence on the immune system (eg, tumor necrosis factor inhibitors, interleukin inhibitors, B-cell inhibitors), including investigational agents, within 12 months or 5 times the t½ plus 6 months before Screening, whichever is longer. * Participants who are currently receiving anti-coagulation therapy. * Participants with hypoalbuminemia, protein-losing enteropathies, and kidney diseases with proteinuria. * Participants with a documented history or a current diagnosis of a thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident, transient ischemic attack) or coagulopathy within 12 months before Screening. * Participants with severe dehydration and known blood disorders affecting viscosity. * Participants with aspartate aminotransferase and alanine aminotransferase concentration \> 3 times the upper limit of normal (ULN; central laboratory) at Screening. * Participants with creatinine concentration \> 1.5 times the ULN (central laboratory) at Screening. * Participants with new onset or worsening or severe cardiac, pulmonary, kidney disease, and liver disease. * Participants with malignancies of lymphoid cells such as chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Allergy & Clinical Immunology
Pittsburgh, Pennsylvania, 15241, United States
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Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
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Immunoe Health Centers
Centennial, Colorado, 80112, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Medical Research of Arizona
Scottsdale, Arizona, 85251, United States
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Midwest Immunology
Plymouth, Minnesota, 55446, United States
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Research Solutions of AZ
Litchfield Park, Arizona, 85340, United States
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Washington University
St Louis, Missouri, 63141, United States
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