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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- 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.
Locations
United States
Arizona
Research Solutions of AZ
RECRUITING
Litchfield Park
Medical Research of Arizona
RECRUITING
Scottsdale
Colorado
Immunoe Health Centers
RECRUITING
Centennial
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Minnesota
Midwest Immunology
RECRUITING
Plymouth
Missouri
Washington University
RECRUITING
St Louis
Oklahoma
Allergy, Asthma and Clinical Research Center
RECRUITING
Oklahoma City
Pennsylvania
Allergy & Clinical Immunology
RECRUITING
Pittsburgh
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+1 610-878-4697
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2026-05-04
Participants
Target number of participants: 8
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: CSL Behring