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Study of human normal immunoglobulin to prevent major infections in patients with hypogammaglobulinemia and autoimmune/rheumatic disease on B‑cell depletion therapy

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial looks at people who have low levels of antibodies (called hypogammaglobulinemia) and who also have conditions where the immune system attacks the body, such as autoimmune or rheumatic conditions. These patients often receive medicines that remove B cells (B-cell depletion therapy), which can further weaken the immune system and increase the risk of serious infections. The study tests an intravenous solution of Panzyga, which contains human normal immunoglobulin, compared with a simple salt solution (sodium chloride) used as a placebo.

The aim is to see if adding Panzyga can lower the chance of a major infection or death in this vulnerable group. Participants will receive the assigned infusion once every few weeks for several months, and they will be checked regularly by doctors for any signs of infection, side effects, or changes in health. The study is set up so that neither the participants nor the doctors know which infusion is being given, to keep the comparison fair.

Throughout the trial, any infection that occurs will be recorded, and an independent group of experts will decide whether it meets the definition of a major infection. Safety will also be monitored by looking at reported side effects and routine lab tests. The information gathered will help determine whether the treatment is safe and effective for preventing serious infections in people with weak immune systems due to their underlying disease and therapy.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization (double‑blind assignment)

    After you join the study, you are randomly assigned to receive either the active medication or a placebo. the assignment is double‑blind, meaning neither you nor the study staff know which one you receive.

    The active medication is panzyga 100 mg/ml infusion solution. the placebo is isotone saline solution.

  2. Step 2

    Baseline assessments

    Before the first infusion, a series of checks are performed, including physical examination, laboratory tests, and confirmation of your medical condition (low antibody levels, known as hypogammaglobulinemia, and treatment with b‑cell depletion therapy).

    The results create a reference point for later safety and effectiveness evaluations.

  3. Step 3

    First infusion

    You receive an intravenous infusion of the assigned product. the dose is 4 ml per kilogram of body weight, delivered through a vein.

    The infusion is performed in a clinical setting where vital signs are monitored before, during, and after the procedure.

  4. Step 4

    Scheduled follow‑up infusions

    Additional infusions of the same product are given at each scheduled visit according to the study protocol. each infusion uses the same dose of 4 ml per kilogram and follows the same safety monitoring procedures.

    The exact timing of these visits is defined by the study schedule, which continues for the duration of the trial.

  5. Step 5

    Regular monitoring visits

    At each visit you undergo physical examinations and laboratory tests to check for any side effects or changes in health.

    Any new symptoms, especially signs of infection, are recorded and evaluated by an independent committee.

  6. Step 6

    Infection surveillance

    Throughout the study you are asked to report any illness that could be a major infection. a major infection is defined as a serious infection that may require hospitalization or lead to death.

    Each reported infection is reviewed to determine its type, severity, and the time it takes to resolve.

  7. Step 7

    Final assessment

    At the end of the study period, a final set of examinations and laboratory tests is performed.

    The data collected from all visits are used to evaluate the benefit of the active medication compared with the placebo for preventing major infections.

Who can join the trial?

4 criteria

  • You are 18 years or older, have been diagnosed with a rheumatic or autoimmune condition (such as multiple sclerosis, rheumatoid arthritis, lupus, or similar diseases), received your last dose of B‑cell depletion therapy within the past 3 months, and plan to continue this therapy while in the study.
  • You have hypogammaglobulinemia, meaning a low level of the antibody protein IgG (less than 5 g/L) confirmed by a laboratory test.
  • You are willing and able to sign a voluntary written informed consent and follow all study requirements.
  • You agree to use an acceptable and effective method of birth control (effective contraception) during the treatment period and for 30 days after the last dose; this applies to anyone who could become pregnant (child‑bearing potential), following local rules.

Who cannot join the trial?

17 criteria

  • Have had a severe allergic reaction called anaphylaxis to immunoglobulin, blood, plasma‑derived products, or any part of Panzyga (a serious whole‑body allergy).
  • Have a major infection right now, or have had more than one major infection in the six months before the study starts.
  • Have a recent history (within six months) of blood clot problems such as deep vein thrombosis (clot in a leg vein), pulmonary embolism (clot in the lungs), heart attack, stroke, mini‑stroke (transient ischemic attack), or very severe peripheral artery disease.
  • Have a known deficiency of IgA antibodies together with antibodies that react against IgA (which can cause dangerous reactions).
  • Have a condition that makes the blood too thick (blood hyperviscosity) or a tendency to clot too easily (hypercoagulable state).
  • Have been diagnosed with a primary immunodeficiency (a lifelong problem with the immune system).
  • Have severe liver disease with signs of fluid buildup in the abdomen (ascites) or brain confusion caused by liver failure (hepatic encephalopathy).
  • Have severe kidney disease, defined as an estimated filtration rate (eGFR) less than 30 mL/min/1.73 m².
  • Weigh more than 140 kg (about 308 lb).
  • Test positive for HIV at screening (positive HIV NAT test or positive HIV‑1/2 antigen/antibody test confirmed by a differentiation test).
  • Are a chronic carrier of hepatitis B virus (positive surface antigen, core antibodies, or low virus levels) without receiving antiviral therapy, or have active hepatitis B with high virus levels.
  • Have uncontrolled hepatitis C infection at screening (positive HCV PCR test).
  • Have received IgG treatment within the past six months or plan to receive IgG therapy (other than the study drug) during the study.
  • Are receiving or plan to receive other immunosuppressive medicines (drugs that lower the immune system) that are not part of the required treatment for the underlying condition.
  • Are taking part in, or plan to take part in, another blinded or investigational drug study within three months before the start or during this study (open‑label studies with approved products may be allowed after review).
  • If you are a woman, you are pregnant or breastfeeding.
  • You are likely to be non‑compliant, unable to cooperate because of language problems, or have poor mental development, as judged by the investigator.
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Investigated drugs

Panzyga is a solution that contains normal human antibodies (immunoglobulins) and is given through an IV. In this study it is used to replace the missing antibodies that can occur in patients whose immune system is weakened by B‑cell depletion therapy. By providing these antibodies, Panzyga helps the body fight off germs and aims to lower the chance of serious infections in people with low levels of immunoglobulin and autoimmune or rheumatic diseases.

What is already known about the treatment

  • Panzyga

    Panzyga is given by intravenous infusion, usually 4 ml per kilogram of body weight, as a clear solution that is pumped into a vein. It is a human normal immunoglobulin product that is already approved and widely described in medical literature for treating immune deficiencies. The drug is used to help prevent serious infections in people whose antibody levels are low because of B‑cell‑depleting therapy for autoimmune or rheumatic diseases. It works by adding pooled IgG antibodies that can bind to many germs, supporting the body’s natural defense, and it belongs to the class of human immunoglobulin (normal) preparations.

  • Normal Saline

    Normal Saline is administered intravenously as an isotonic 0.9 % sodium chloride solution, typically 4 ml per kilogram, and is infused directly into a vein. It is a universally accepted electrolyte solution that is well established in clinical practice and medical references. The solution is used to replace lost fluids and maintain salt balance, and in clinical trials it serves as a placebo control. It works by providing sodium and chloride ions that match the concentration of blood plasma, helping to keep fluid balance, and it is classified as an electrolyte (electrolytes) solution.

Investigated diseases

  • Hypogammaglobulinemia

    A condition where the blood contains unusually low levels of immunoglobulins, the proteins that help fight infections. It results from reduced production of antibodies by B cells. Over time, the reduced antibody supply can make a person more prone to repeated infections. The low immunoglobulin levels may persist or gradually worsen if the underlying cause is not resolved. Some individuals may experience a slow decline in immune function as they age.

  • Autoimmune disease

    A group of disorders in which the immune system mistakenly attacks the body’s own tissues. The mistaken attack can cause inflammation and damage in various organs. The condition often begins subtly and may progress to more widespread tissue involvement. Symptoms can increase in frequency or intensity as the immune response escalates. The disease course can vary, with periods of increased activity followed by quieter phases.

  • Rheumatic disease

    A collection of disorders that affect joints, muscles, and connective tissues, causing pain and stiffness. Inflammation in the affected areas can lead to gradual loss of mobility. The condition may start in a few joints and spread to others over time. Ongoing inflammation can cause structural changes in joints if the disease continues unchecked. The progression often follows a pattern of flare-ups and partial relief.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522854-37-00Protocol codeNGAM-16Estimated enrolment410 patientsSponsorOctapharma Pharmazeutika Produktionsgesellschaft mbH

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