2025-522854-37-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infections in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy ("PROTECT")
Octapharma Pharmazeutika Produktionsgesellschaft mbH22 个研究点 分布在 8 个国家目标入组 215 人开始时间: 2026年5月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 22
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
- •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 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.
排除标准
- •Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
- •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)
- •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.
- •Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).
- •Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study
- •Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration
- •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.
- •If female, are pregnant or lactating
- •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
- •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 (DVT), pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
- •Have a known IgA deficiency with antibodies to IgA
- •Have a known blood hyperviscosity or other hypercoagulable states
- •Have been diagnosed with primary immunodeficiency
- •Have a severe liver disease, with signs of ascites or hepatic encephalopathy
- •Have a severe kidney disease (as defined by eGFR <30 mL/min/1.73 m2)
- •Have body weight >140 kg
研究组 & 干预措施
Panzyga 100 mg/ml Infusionslösung
Test
干预措施: Panzyga 100 mg/ml Infusionslösung (Drug)
Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
Placebo
干预措施: Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung (Drug)
研究者
Global Clinical Project Manager
Scientific
Octapharma Pharmazeutika Produktionsgesellschaft mbH
研究点 (22)
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