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)

NCT07076446 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: IgPro20_4007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Primary Immunodeficiency

Keywords

Immunoglobulin replacement therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

IgPro20

EXPERIMENTAL

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

Interventions

IgPro BIOLOGICAL

IgPro20 is a solution for infusion for subcutaneous administration.

Also known as: Immune globulin subcutaneous (Human) 20% liquid

IgPro20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (8)

Research Solutions of AZ

Litchfield Park, Arizona, 85340, United States

Location

Medical Research of Arizona

Scottsdale, Arizona, 85251, United States

Location

Immunoe Health Centers

Centennial, Colorado, 80112, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Midwest Immunology

Plymouth, Minnesota, 55446, United States

Location

Washington University

St Louis, Missouri, 63141, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy & Clinical Immunology

Pittsburgh, Pennsylvania, 15241, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins; Fluid Therapy

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Therapy; Therapeutics

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 22, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (8)