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OpenTrials
Completed

NCT Number: NCT07076446

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Solutions of AZ, Litchfield Park, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IgPro

Biological

IgPro20 is a solution for infusion for subcutaneous administration.

Other names: Immune globulin subcutaneous (Human) 20% liquid

Primary outcomes

  1. Trough concentration (Ctrough) Levels of IgPro20

    Time frame: Up to Week 13

  2. Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs

    Time frame: Up to Day 85

  3. Number of TEAEs and Serious TEAEs Events

    Time frame: Up to Day 85

  4. TEAEs and Serious TEAEs Event Rates Per Days with Infusion

    Time frame: Up to Day 85

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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