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RECRUITING Phase 4

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • BIOLOGICAL IgPro

Study Locations (8)

Arizona

  • Research Solutions of AZ — Litchfield Park
  • Medical Research of Arizona — Scottsdale

Colorado

  • Immunoe Health Centers — Centennial

Maryland

  • Johns Hopkins Bayview Medical Center — Baltimore

Minnesota

  • Midwest Immunology — Plymouth

Missouri

  • Washington University — St Louis

Oklahoma

  • Allergy, Asthma and Clinical Research Center — Oklahoma City

Pennsylvania

  • Allergy & Clinical Immunology — Pittsburgh

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2025-07-15
Est. Completion 2026-05-04
Phase Phase 4

Sponsor

CSL Behring

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07076446

The ClinicalTrials.gov registry entry for NCT07076446 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Primary Immunodeficiency appearing as the primary indexed condition, and to 1 intervention — of which IgPro is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07076446 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Arizona, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07076446 about?

NCT07076446 is a clinical study titled "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 tolerabilit...

What is the current status of trial NCT07076446?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2025-07-15. Estimated completion is 2026-05-04.

What conditions does trial NCT07076446 study?

This clinical trial studies the following conditions: Primary Immunodeficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07076446?

The interventions under investigation include: IgPro (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07076446?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07076446 being conducted?

This trial has 8 study locations across Arizona, Colorado, Maryland, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial