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New immune boost for rare immune disorder? small trial underway

NCT ID NCT07076446

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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: * 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.

inborn error of immunity Primary Immunodeficiency Diseases

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

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120, United States

  • Immunoe Health Centers

    Centennial, Colorado, 80112, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251, United States

  • Midwest Immunology

    Plymouth, Minnesota, 55446, United States

  • Research Solutions of AZ

    Litchfield Park, Arizona, 85340, United States

  • Washington University

    St Louis, Missouri, 63141, United States

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