RecruitingPhase 4NCT07076446

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)

An Open-label, Multicenter Study to Assess the Pharmacokinetics, Safety, and Tolerability of Immune Globulin Subcutaneous (Human) IgPro20 in IG Treatment-naïve Subjects With Primary Immunodeficiency

Sponsor

CSL Behring

Enrollment

8 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Immunodeficiency

Summary

This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (\>=) 18 years.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

\- 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 Criteria13

\- 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.