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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Immunodeficiency
• Intervention / Treatment: Biological: IgPro

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of AZ
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Immunoe Health Centers
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Midwest Immunology
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Washington University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IgPro20; All participants will receive a loading dose of IgPro20 daily from Day 1 to 5 in Week 1, followed by weekly administration of the maintenance dose of IgPro20 from Day 8 (Week 2) to Day 78 (Week 12).	Biological: IgPro; IgPro20 is a solution for infusion for subcutaneous administration.; Other Names: Immune globulin subcutaneous (Human) 20% liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trough concentration (Ctrough) Levels of IgPro20	Up to Week 13
Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs	Up to Day 85
Number of TEAEs and Serious TEAEs Events	Up to Day 85
TEAEs and Serious TEAEs Event Rates Per Days with Infusion	Up to Day 85

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Study Director, CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 15, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immunoglobulin replacement therapy
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Immunologic Deficiency Syndromes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Drug Therapy; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; gamma-Globulins; Fluid Therapy
• Other Study ID Numbers: IgPro20_4007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
• IPD Sharing Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No