Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections (NCT07220915) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
360 participantsStarted 2026-06
Plain-language summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, 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.
. Have hypogammaglobulinemia (IgG levels \<5 g/L as confirmed by the central laboratory).
. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..
. Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
. Have a current major infection at Screening or had \>1 major infection within 6 months prior to Baseline
. Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing Panzyga to prevent serious infections in people with weakened immune systems caused by autoimmune or rheumatic disease treatments — given that I'm on or considering similar treatments, is this the kind of immune weakening my doctor would be watching for in me?
2Since this is a Phase 3 trial, what do we already know about Panzyga's safety and effectiveness from earlier studies, and how does that compare to other options already available for managing low antibody levels?
3The trial isn't recruiting yet — if it opens and my doctor thinks I might be a candidate, how would getting Panzyga through this trial differ from getting intravenous immunoglobulin therapy through standard care right now?
4The main thing this trial is measuring is whether serious infections happen less often — what counts as a 'major infection' in this context, and how often would those realistically be a risk for someone in my situation?
5What would need to be true about my current antibody levels, infection history, or type of autoimmune treatment for my doctor to consider this trial worth discussing as an option for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.