RECRUITING

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)

Description

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.

Conditions

Primary Immunodeficiency
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Related Conditions:

Primary Immunodeficiency

Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Primary Immunodeficiency
Intervention / Treatment

-

Contacts and Locations

Litchfield Park

84000890 - Research Solutions of AZ, Litchfield Park, Arizona, United States, 85340

Centennial

84000910 - Immunoe Health Centers, Centennial, Colorado, United States, 80112

Plymouth

84000918 - Midwest Immunology, Plymouth, Minnesota, United States, 55446

Oklahoma City

84000885 - Allergy, Asthma and Clinical Research Center, Oklahoma City, Oklahoma, United States, 73120

Pittsburgh

84000884 - Allergy & Clinical Immunology, Pittsburgh, Pennsylvania, United States, 15241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

2026-05-04