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Primary ImmunodeficiencyPhase 4NCT07076446

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 testing IgPro in people with Primary Immunodeficiency, run by CSL Behring at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Immunodeficiency
What is being tested?
IgPro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
8 sitesUnited States
Study dates
15 Jul 2025to 30 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Immunoe Health Centers

    Centennial, Colorado, 80112

  • Research Solutions of AZ

    Litchfield Park, Arizona, 85340

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Allergy & Clinical Immunology

    Pittsburgh, Pennsylvania, 15241

  • Midwest Immunology

    Plymouth, Minnesota, 55446

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251

  • Washington University

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: 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

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.

Being tested
IgPro
Keywords
Immunoglobulin replacement therapy
Medical subject headings
Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IgProBiological

    Also called Immune globulin subcutaneous (Human) 20% liquid

    IgPro20 is a solution for infusion for subcutaneous administration.

Study groups in NCT07076446
Study groupRoleWhat they receive
IgPro20ExperimentalAll 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).
Receives: Biological: IgPro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough concentration (Ctrough) Levels of IgPro20

    Measured: Up to Week 13

  2. Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs

    Measured: Up to Day 85

  3. Number of TEAEs and Serious TEAEs Events

    Measured: Up to Day 85

  4. TEAEs and Serious TEAEs Event Rates Per Days with Infusion

    Measured: Up to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start15 Jul 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076446
Sponsor's protocol ID
IgPro20_4007
Status last verified
Jul 2026
First submitted
15 Jul 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IgPro in people with Primary Immunodeficiency, run by CSL Behring at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough concentration (Ctrough) Levels of IgPro20 (time frame: Up to Week 13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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