[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220915":3,"trial-entities:NCT07220915":87,"trial-summary:NCT07220915":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":84,"references":85,"see_also_links":86},"NCT07220915","NGAM-16","Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections","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 (\"PROTECT\")","RECRUITING","2029-12","2026-07","2026-07-22","2026-06-10","Octapharma","INDUSTRY",false,"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",null,[19,20,21,22],"Hypogammaglobulinemia","Autoimmune Conditions","Rheumatic Conditions","Infections",[],"INTERVENTIONAL","PREVENTION",[27],"PHASE3",{"count":29,"type":30},360,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Panzyga, 10% Intravenous Solution","Panzyga is a 10% Ig formulation for intravenous (IV) administration",[37],"Panzyga 10%",{"type":39,"name":40,"description":41,"armGroupLabels":42},"OTHER","Placebo","4 mL\u002Fkg 0.9% w\u002Fv sodium chloride solution per single IV infusion",[40],[44],{"measure":45,"description":46,"timeFrame":47},"Occurrence of Major Infections in Participants","Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and\u002For viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.","48 weeks",[49,52,55],{"measure":50,"description":51,"timeFrame":47},"Time to Major Infections in Participants","Time to first major infection (as assessed by the IAC) during the treatment period or death. The secondary safety endpoints of this study include the incidence of adverse events and changes from baseline in physical examinations and clinical laboratory parameters.",{"measure":53,"description":54,"timeFrame":47},"Number of Participants Experiencing AEs","Incidents of AEs during the treatment period",{"measure":56,"description":57,"timeFrame":58},"Participants Experiencing Changes from Baseline in Physical Examinations, and Clinical Laboratory Parameters","Changes from baseline in physical examination findings and clinical laboratory parameters will be assessed during the treatment period. Each parameter will be reported separately according to its unit of measure, such as body weight (kg), height (cm), body mass index (kg\u002Fm²), and individual laboratory values (e.g., hemoglobin \\[g\u002FdL\\], serum creatinine \\[mg\u002FdL\\]). Where applicable, related measurements (e.g., weight and height) will be combined to derive a single parameter, such as body mass index, to ensure consistent and interpretable results.","48 Weeks","ALL","18 Years",{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. 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\u002Fmyositis, 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.\n2. Have hypogammaglobulinemia (IgG levels \\\u003C5 g\u002FL as confirmed by the central laboratory).\n3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..\n4. 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.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component\n2. Have a current major infection at Screening or had \\>1 major infection within 6 months prior to Baseline\n3. 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\n4. Have a known IgA deficiency with antibodies to IgA\n5. Have a known blood hyperviscosity or other hypercoagulable states\n6. Have been diagnosed with primary immunodeficiency.\n7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy\n8. Have a severe kidney disease (as defined by eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n9. Have a body weight \\>140 kg\n10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1\u002F2 antigen\u002Fantibody immunoassay followed by positive HIV-1\u002FHIV-2 antibody differentiation immunoassay)\n11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and\u002For 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.\n12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).\n13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study\n14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration\n15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product 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.\n16. If female, are pregnant or lactating\n17. 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",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Perseverance Research Center, Phoenix Neurological Associates","Scottsdale","Arizona","85253","United States",{"lat":76,"lon":77},33.50921,-111.89903,[79],{"name":80,"role":81,"phone":82,"email":83},"Patrick Murphy","CONTACT","413-821-0022","p.murphy@crmg-usa.com",[],[],[],{"nct_id":4,"conditions":88,"biomarkers":104},[89,90,91,19,92,93,94,95,96,97,98,99,100,101,102,103],"Autoimmune Disease","Autoimmune Encephalitis","Chronic Inflammatory Demyelinating Polyneuropathy","Idiopathic Inflammatory Myopathy","Mixed Connective Tissue Disease","Multiple Sclerosis","Myasthenia Gravis","Myositis","Neuromyelitis Optica","Rheumatism","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Undifferentiated Connective Tissue Disease","Vasculitis",[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is a Phase 3, randomized, double-blind, placebo-controlled study involving 360 participants across multiple locations.","completed","Panzyga for Preventing Infections in Autoimmune Conditions","This study is testing if Panzyga, an intravenous (IV) solution, can help prevent serious infections in people with autoimmune or rheumatic conditions (like rheumatoid arthritis or lupus) who also have hypogammaglobulinemia (a weak immune system). Participants will receive either Panzyga or a placebo (a salt water solution) through an IV. The main goal is to see how many major infections occur in each group over 48 weeks. You may be able to join if you are at least 18 years old, have an autoimmune or rheumatic condition, and are receiving B-cell depletion therapy. The study is currently recruiting 360 participants.","Participants will be followed for the occurrence of major infections for 48 weeks.",100,"Not specified in the trial record.","Not stated in the trial record.",[40],"v2"]