An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)

Launched by CSL BEHRING · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called IgPro20, given as a shot under the skin, to see how it works and how safe it is for adults with primary immunodeficiency (PID) who have never received immunoglobulin (IG) treatment before. PID is a condition where the immune system doesn’t work properly, making it harder to fight infections. The study aims to understand how the body processes this medicine and to check if it is well-tolerated without causing serious side effects.

Adults aged 18 and older with a confirmed diagnosis of PID and low levels of a certain immune protein (IgG) may be eligible to join. However, people who have certain other health issues, take specific medications that affect the immune system, or have had recent serious blood clots or cancer are not allowed to participate. If you join the study, you can expect regular health check-ups to monitor how the medicine is working and to make sure it’s safe for you. This study is not yet recruiting participants but is planned to take place at several locations in the United States.

Gender

ALL

Eligibility criteria

• 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.