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Study on the Effects of Subcutaneous Human Immunoglobulin (Newnorm) for Patients with Primary Immunodeficiency Diseases

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What is this trial about?

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

This clinical trial is focused on studying a group of diseases known as primary immunodeficiency diseases (PID). These are conditions where the immune system does not function properly, making it difficult for the body to fight off infections. The treatment being tested in this study is called Newnorm, which is a form of human normal immunoglobulin. This is a solution that is given through an infusion under the skin, known as subcutaneous administration. The purpose of the study is to evaluate how well Newnorm works in preventing serious bacterial infections in patients with PID.

Participants in the study will receive Newnorm once a week. The study aims to ensure that this weekly treatment maintains levels of a protein called immunoglobulin G (IgG) in the blood, which helps protect against infections, at levels similar to those achieved with less frequent treatments. The study will last for about a year, during which the safety and effectiveness of Newnorm will be closely monitored. Researchers will look at how often serious infections occur, how quickly infections resolve, and other factors like the use of antibiotics and hospital visits due to infections.

Throughout the study, participants will be asked to provide information about their health and any infections they experience. This will help researchers understand the impact of Newnorm on their quality of life, including time lost from work or school due to illness. The study is designed to gather important information that could lead to better treatment options for people with primary immunodeficiency diseases.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and a documented diagnosis of primary immunodeficiency diseases (PID).

    Consent is required from adult patients or from the parent/legal guardian of pediatric patients.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of Newnorm, a solution for infusion containing human normal immunoglobulin.

    The medication is administered subcutaneously, which means it is injected under the skin.

  3. Step 3

    Dosage and frequency

    The dosage is adjusted by a dose conversion factor of 1.37 for patients previously treated with an intravenous immunoglobulin product.

    The treatment is administered weekly to maintain average total immunoglobulin G (IgG) levels.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the efficacy of Newnorm in preventing serious bacterial infections.

    Blood samples are taken periodically to measure IgG levels and ensure they remain stable.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the rate of serious bacterial infections per person-year on treatment.

    Secondary outcomes include the rate of all infections, use of antibiotics, hospitalizations due to infection, and quality of life assessments.

  6. Step 6

    Study duration

    The study is conducted over a 52-week period to evaluate the long-term efficacy and safety of the treatment.

    The estimated end date for the study is September 23, 2025.

Who can join the trial?

6 criteria

  • Age between 2 and 75 years old.
  • Have a confirmed diagnosis of **PID**. PID stands for **Primary Immunodeficiency Disease**, which is a condition where the immune system doesn't work properly. This diagnosis must be confirmed by specific medical groups and require treatment with **immunoglobulin replacement therapy** due to low levels of antibodies, known as **hypogammaglobulinemia** or **agammaglobulinemia**.
  • Have been receiving regular treatment for at least 12 weeks before the study starts. This treatment should be with a stable dose of **IVIG** (intravenous immunoglobulin), **SCIG** (subcutaneous immunoglobulin), or **fSCIG** (facilitated subcutaneous immunoglobulin), with a dose between 200 and 800 mg/kg/month. A stable dose means it doesn't change more than 25% from the average dose during this period.
  • Have a **trough level** of **IgG** (immunoglobulin G) of at least 5 g/L at the start of the study and have had this level at least once in the previous 12 weeks. A trough level is the lowest concentration of a drug in the bloodstream before the next dose is given.
  • Provide written informed consent if an adult, or if a child or adolescent, have written consent from a parent or legal guardian and give their own written agreement to participate, following the rules that apply.
  • Be willing to follow all parts of the study plan, including giving blood samples, for the entire duration of the study.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or severe reaction to **immunoglobulin** products. Immunoglobulin is a protein in the blood that helps fight infections.
  • Patients with a history of severe **thrombosis**. Thrombosis is when a blood clot forms in a blood vessel and can block blood flow.
  • Patients with a condition called **IgA deficiency** with antibodies against IgA. IgA is a type of immunoglobulin, and having antibodies against it can cause reactions.
  • Patients with a history of severe **anaphylactic reactions** to blood products. Anaphylactic reactions are severe allergic reactions that can be life-threatening.
  • Patients who are currently receiving another investigational drug. Investigational drugs are those that are still being tested and are not yet approved for general use.
  • Patients with a history of **chronic kidney disease**. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should.
  • Patients with a history of **liver disease**. Liver disease affects the liver's ability to function properly.
  • Patients who are pregnant or breastfeeding. Pregnancy and breastfeeding can affect how the body responds to treatments.
  • Patients with a history of **heart disease**. Heart disease affects the heart's ability to pump blood effectively.
  • Patients with a history of **stroke**. A stroke occurs when blood flow to a part of the brain is interrupted, causing brain cells to die.
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Investigated drugs

Newnorm is a subcutaneous human immunoglobulin used in this clinical trial. It is designed to help patients with primary immunodeficiency diseases by providing them with the necessary antibodies to fight infections. The study aims to evaluate how well Newnorm works in preventing serious bacterial infections and to ensure it is safe and well-tolerated by patients. The trial also examines how the body processes Newnorm when given weekly, compared to the traditional intravenous immunoglobulin treatments that are administered every 3 to 4 weeks.

What is already known about the treatment

Newnorm – Newnorm is administered as a subcutaneous injection, designed for patients with primary immunodeficiency diseases. It is currently being evaluated in a Phase 3 clinical trial to determine its effectiveness and safety. The main therapeutic use of Newnorm is to prevent serious bacterial infections in individuals with compromised immune systems. At the molecular level, it works by providing human immunoglobulin G (IgG), which helps enhance the body's immune response. Pharmacologically, it is classified as a human normal immunoglobulin.

Investigated diseases

Human Normal Immunoglobulin – Human Normal Immunoglobulin is a preparation of antibodies derived from the plasma of healthy donors. It is used to provide passive immunity to individuals who are unable to produce sufficient antibodies on their own. This condition can occur due to various immune deficiencies, where the body lacks the ability to fight off infections effectively. The immunoglobulin is administered to help prevent serious bacterial infections such as bacterial pneumonia, meningitis, and sepsis. It works by supplementing the immune system with antibodies that can recognize and neutralize pathogens. The treatment is typically given through intravenous or subcutaneous routes, depending on the specific needs of the patient.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511231-94-00Protocol codeNORM-01Estimated enrolment72 patientsSponsorOctapharma Pharmazeutika Produktionsgesellschaft mbH

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