Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOctapharma
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Have a known IgA deficiency with antibodies to IgA
Trial design
Design model
Parallel
Treatments tested in this trial
Panzyga, 10% Intravenous Solution
DrugPanzyga is a 10% Ig formulation for intravenous (IV) administration
Placebo
Other intervention4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Panzyga 10%Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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/or 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.
Time frame
48 weeksSecondary outcomes
1
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.
Time frame
48 weeks2
Number of Participants Experiencing AEs
Incidents of AEs during the treatment period
Time frame
48 weeks3
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/m²), and individual laboratory values (e.g., hemoglobin \[g/dL\], serum creatinine \[mg/dL\]). 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.
Time frame
48 Weeks Source ClinicalTrials.gov