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)
- Conditions
- Primary Immunodeficiency
- Interventions
- Biological: IgPro
- Registration Number
- NCT07076446
- Lead Sponsor
- CSL Behring
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8
- 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.
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Participants with hyperprolinemia.
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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.
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Participants with hypoalbuminemia, protein-losing enteropathies, and kidney diseases with proteinuria.
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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.
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Participants with severe dehydration and known blood disorders affecting viscosity.
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Participants with aspartate aminotransferase and alanine aminotransferase concentration > 3 times the upper limit of normal (ULN; central laboratory) at Screening.
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Participants with creatinine concentration > 1.5 times the ULN (central laboratory) at Screening.
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Participants with new onset or worsening or severe cardiac, pulmonary, kidney disease, and liver disease.
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Participants with malignancies of lymphoid cells such as chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IgPro20 IgPro 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).
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
84000890 - Research Solutions of AZ
🇺🇸Litchfield Park, Arizona, United States
84000910 - Immunoe Health Centers
🇺🇸Centennial, Colorado, United States
84000918 - Midwest Immunology
🇺🇸Plymouth, Minnesota, United States
84000885 - Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
84000884 - Allergy & Clinical Immunology
🇺🇸Pittsburgh, Pennsylvania, United States
84000890 - Research Solutions of AZ🇺🇸Litchfield Park, Arizona, United StatesTrial Information ContactContact