IgPro20 for Primary Immunodeficiency

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: CSL Behring

Must not be taking: Corticosteroids, Immunosuppressants, Biologics, Anticoagulants

Disqualifiers: Hyperprolinemia, Thromboembolic events, Kidney diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests IgPro20, a treatment for individuals with primary immunodeficiency (PID), a condition where the immune system malfunctions. The goal is to understand how the body processes the treatment and to assess its safety for those who have never received immune globulin (IG) treatment. Suitable candidates have a confirmed PID diagnosis and low levels of specific antibodies. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. Specifically, you cannot be on high doses of systemic corticosteroids, systemic immunosuppressants, biologic therapies affecting the immune system, or anti-coagulation therapy. If you're on any of these, you might need to stop them before participating.

What is the safety track record for IgPro20?

Research has shown that IgPro20 is generally safe and well-tolerated. Studies have found that people with primary immunodeficiency (PID) who used IgPro20 experienced few side effects. In Japanese patients with PID, IgPro20 proved effective and well-tolerated. Additionally, a review of reports over ten years confirmed that IgPro20 is consistently safe. While some people might experience minor side effects, these are usually easy to manage. This treatment maintains a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

IgPro20 is unique because it offers a more frequent yet potentially effective dosing schedule for managing primary immunodeficiency. Unlike traditional treatments, which often require less frequent infusions or injections, IgPro20 begins with a loading dose administered daily for the first five days, followed by weekly maintenance doses. This approach could lead to more stable immunoglobulin levels in the body, potentially reducing breakthrough infections and improving overall quality of life. Researchers are excited about its potential to offer a more consistent and manageable treatment routine for patients.

What is the effectiveness track record for IgPro20 in treating primary immunodeficiency?

Research shows that IgPro20 effectively treats primary immunodeficiency (PID). Studies have found that it helps protect patients from infections by maintaining strong levels of IgG, an important antibody, in the blood without causing unexpected side effects. Patients generally tolerate the treatment well. Overall, strong evidence supports its use for PID. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

CSL Behring

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who have never been treated with immunoglobulin and are diagnosed with Primary Immunodeficiency (PID). Specific eligibility details aren't provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

I am 18 years old or older.

I have PID, haven't had IG treatments, and my IgG level is ≤ 400 mg/dL.

Exclusion Criteria

Participants with aspartate aminotransferase and alanine aminotransferase concentration greater than 3 times the upper limit of normal (ULN) at Screening.

Participants with creatinine concentration greater than 1.5 times the ULN at Screening.

I have high levels of proline in my blood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a loading dose of IgPro20 daily from Day 1 to 5 in Week 1, followed by weekly administration of the maintenance dose from Day 8 (Week 2) to Day 78 (Week 12)

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IgPro20

Trial Overview The study is testing IgPro20, a medication given under the skin to treat PID. It's an open-label, multicenter phase 4 trial in the US focusing on how the body processes the drug and its safety and tolerability in new patients.

How Is the Trial Designed?

Group I: IgPro20 Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Recruited

1,207,000+

Dr. Paul McKenzie

CSL Behring

Chief Executive Officer since 2023

PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3937544/

Efficacy and Safety of IgPro20, a Subcutaneous ... Conclusion. IgPro20 was effective and well tolerated in Japanese patients with PID. Keywords: Primary immunodeficiency, PID, primary antibody ...

2. jacionline.org jacionline.org/article/S0091-6749(09)02346-X/fulltext

Efficacy and Safety of a New 20% Immunoglobulin ... CONCLUSIONS: IgPro20 effectively protects PID patients against infections. The 20% concentration sustains serum IgG levels without causing unexpected AEs. High ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01461018

NCT01461018 | Multicenter Study of Long-Term Clinical ... The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an ...

4. ajmc.com ajmc.com/view/igpro20-well-tolerated-by-most-patients-with-pid-according-to-phase-4-study-data

IgPro20 Well Tolerated by Most Patients With PID ... IgPro20 were well tolerated by patients with primary immunodeficiency disorder (PID), according to a recent abstract prepared for the American Academy of ...

5. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.753

Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 ... This PK analysis demonstrated similar systemic IgG exposure after weekly and biweekly IgPro20 dosing with an equivalent monthly dose in patients with PID.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03033745

Study Details | NCT03033745 | Safety and Tolerability of ... This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate safety and tolerability of higher infusion parameters of IgPro20 in ...

7. jacionline.org jacionline.org/article/S0091-6749(24)01518-5/fulltext

IgPro20 Real World Use: Decade of Consistent Safety We investigated spontaneous reports of adverse events in patients having received IgPro20. Methods. The CSL Behring safety database was used to retrieve all ...

8. medicalaffairs.cslbehring.com medicalaffairs.cslbehring.com/diseases-and-conditions/allergy-and-immunology/pid/key-publications

Key Publications (PID) - CSL Behring Medical Affairs Safety Profile of High IgPro20 Infusion Parameters in Patients With Primary Immunodeficiency (PID): Results From the Forced Upward Titration HILO Study.

9. education.aaaai.org education.aaaai.org/sites/default/files/097%20Rojavin_0.pdf

Safety Profile of High IgPro20 Infusion Parameters in ... Each infusion parameter level was tested for 4 weeks, after which responders were switched to the next level. The weekly dose remained unchanged during the ...