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NCT07076446 · ClinicalTrials.gov registry record · 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)

A Phase 4 study of Primary Immunodeficiency, sponsored by CSL Behring.

Recruiting
Registry status
Phase 4
Development phase
8
Enrollment target
8
Study locations

NCT07076446 is a Phase 4 study of Primary Immunodeficiency that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 8 participants, below the 5,838-participant average among 4 other Primary Immunodeficiency trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT07076446, a Phase 4 study of Primary Immunodeficiency, is actively recruiting participants, sponsored by CSL Behring.

RECRUITING
Registry status
Phase 4
Development phase
8 participants
Enrollment target
8
Study locations

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

Primary Immunodeficiency

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

71 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, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,838-participant average among 4 other Primary Immunodeficiency trials with a reported enrollment target (100% lower). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

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.

NCT07076446 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Arizona, Colorado, Maryland.

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.

What interventions are being tested in trial NCT07076446?

The interventions under investigation include: IgPro (BIOLOGICAL).

Who is sponsoring clinical trial NCT07076446?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.