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Supporting weak immune system during autoimmune therapy: testing Panzyga to prevent infections
EU CTIS ID: 2025-522854-37-00
What this study is testing
Demonstrate the benefit of Panzyga versus placebo for the prevention of major infections in patients with hypogammaglobulinemia and autoimmune or rheumatic conditions receiving treatment with a BCDT.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during trial participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, Sjogren’s syndrome, idiopathic inflammatory myopathy, mixed connective tissue disease, undifferentiated connective tissue disease, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder. Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.
- 2. Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory).
- 3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements
- 4. Are willing and able to comply with an acceptable effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of child-bearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You likely can't join if
- 1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
- 10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV-1/2 antigen/antibody immunoassay followed by positive HIV-1 /HIV-2 antibody differentiation immunoassay)
- 11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.
- 12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).
- 13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study
- 14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration
See the full eligibility criteria
Who can join
- 1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during trial participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, Sjogren’s syndrome, idiopathic inflammatory myopathy, mixed connective tissue disease, undifferentiated connective tissue disease, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder. Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.
- 2. Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory).
- 3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements
- 4. Are willing and able to comply with an acceptable effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of child-bearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
What rules you out
- 1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
- 10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV-1/2 antigen/antibody immunoassay followed by positive HIV-1 /HIV-2 antibody differentiation immunoassay)
- 11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.
- 12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).
- 13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study
- 14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration
- 15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product (IMP) within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.
- 16. If female, are pregnant or lactating
- 17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator
- 2. Have a current major infection at Screening or had >1 major infection within 6 months prior to Baseline
- 3. Have a history of thromboembolic events such as deep vein thrombosis (DVT), pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
- 4. Have a known IgA deficiency with antibodies to IgA
- 5. Have a known blood hyperviscosity or other hypercoagulable states
- 6. Have been diagnosed with primary immunodeficiency
- 7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy
- 8. Have a severe kidney disease (as defined by eGFR <30 mL/min/1.73 m2)
- 9. Have body weight >140 kg
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.