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Study on Nipocalimab for Adults with Warm Autoimmune Hemolytic Anemia

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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 the effectiveness and safety of a treatment for a condition called warm autoimmune hemolytic anemia (wAIHA). This is a disease where the body's immune system mistakenly attacks and destroys its own red blood cells, leading to anemia. The treatment being tested is a medication known as nipocalimab, which is a type of protein called a monoclonal antibody. This medication is given as a solution through an infusion into a vein.

The purpose of the study is to evaluate how well nipocalimab works in treating adults with wAIHA. Participants in the study will receive either nipocalimab or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the initial phase. After this phase, there will be a long-term extension where all participants may receive nipocalimab.

Throughout the study, participants will have regular visits to monitor their health and the effects of the treatment. The study will assess whether the treatment can improve hemoglobin levels, which are important for carrying oxygen in the blood, without the need for additional rescue therapies. The study aims to provide valuable information on the potential benefits of nipocalimab for people living with wAIHA.

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, the participant will be informed about the trial's purpose, which is to evaluate the effectiveness of nipocalimab in treating warm autoimmune hemolytic anemia.

    The participant will receive detailed information about the study procedures and will be required to provide written consent to participate.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.

    A blood test will be conducted to measure hemoglobin levels and check for signs of hemolysis, such as elevated lactate dehydrogenase or low haptoglobin.

  3. Step 3

    Double-blind period

    During this phase, the participant will receive either nipocalimab or a placebo through an intravenous infusion. The specific product used is JNJ-80202135.

    The infusion will be administered as a solution for infusion, and the participant will not know whether they are receiving the active drug or placebo.

    The participant will attend regular visits to monitor hemoglobin levels and overall health, with the goal of achieving a durable response in hemoglobin improvement.

  4. Step 4

    Monitoring and evaluation

    Throughout the double-blind period, the participant's hemoglobin levels will be checked at multiple visits to assess the treatment's effectiveness.

    The primary goal is to achieve a hemoglobin concentration of at least 10 g/dL and an increase of at least 2 g/dL from baseline at three consecutive visits.

  5. Step 5

    Open-label extension

    Participants who complete the double-blind period or require rescue therapy may enter the open-label extension phase.

    In this phase, all participants will receive nipocalimab to further evaluate its long-term safety and effectiveness.

  6. Step 6

    Completion of the study

    The study is expected to conclude by September 30, 2024.

    Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

15 criteria

  • Participants must be **18 years or older**.
  • Women who can become pregnant must have a **negative pregnancy test** before starting the study and at the beginning of the study.
  • Women who can become pregnant must agree to **avoid pregnancy** by not having sexual intercourse or using a reliable method of birth control during the study and for 30 days after the last dose of the study drug.
  • Men must use a **condom** during any activity that could result in pregnancy during the study and for at least 90 days after the last dose of the study drug. If their partner can become pregnant, they should encourage her to use effective birth control.
  • Participants can use **herbal, naturopathic, traditional Chinese remedies, ayurvedic and nutritional supplements, or medical marijuana** if approved by the study doctor and if they have been using them at a stable dose for at least 2 months before the study.
  • Participants must be able to **understand and sign a consent form** to join the study and follow all study procedures.
  • Participants must have received **vaccinations** according to local guidelines, including for COVID-19, before the study.
  • Participants must have been diagnosed with **warm autoimmune hemolytic anemia (wAIHA)** for at least 3 months and have received treatment for it. New patients who have not been treated are not eligible.
  • Participants must have a **hemoglobin (Hgb) level less than 10 g/dL** and show signs of **hemolysis** (breakdown of red blood cells), such as high levels of lactate dehydrogenase (LDH), low haptoglobin, or high indirect bilirubin. They must also have a positive **Direct Antiglobulin Test (DAT)** for certain antibodies.
  • If taking **corticosteroids**, participants must have been on a stable dose for at least 4 weeks before the study or for at least 14 days before randomization.
  • If taking **immunosuppressants** (drugs that lower the immune system), participants must have been on a stable dose for at least 12 weeks before the study. If they stopped taking them, it must have been at least 8 weeks before the study.
  • Participants must have a **platelet count** of at least 30 x 109/L.
  • Participants who have had their **spleen removed** must be at least 3 months post-surgery and vaccinated according to the recommended schedule for adults.
  • Participants with other **autoimmune diseases** or **lymphoproliferative disorders** (conditions where lymphocytes are produced in excessive quantities) may be eligible if their condition is stable and unlikely to need new treatment during the study.
  • Participants must have **sufficient venous access** for drug administration and blood sampling as required by the study protocol.

Who cannot join the trial?

5 criteria

  • Individuals who do not have **warm autoimmune hemolytic anemia**. This is a condition where the body's immune system mistakenly attacks and destroys its own red blood cells.
  • Participants who are not within the specified age range for the study.
  • Individuals who are not part of the specified clinical trial groups.
  • Participants who are not male or female, as both genders are included in the study.
  • Individuals who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Nipocalimab is a medication being studied for its effectiveness in treating warm autoimmune hemolytic anemia (wAIHA). This condition occurs when the immune system mistakenly attacks and destroys red blood cells, leading to anemia. Nipocalimab is designed to help reduce this immune system attack, potentially improving symptoms and increasing red blood cell counts in patients with wAIHA.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating warm autoimmune hemolytic anemia, a condition where the immune system mistakenly attacks and destroys red blood cells. The medication works by blocking a specific receptor involved in the immune response, which helps reduce the destruction of red blood cells. Nipocalimab is classified as an immunomodulatory agent, which means it helps regulate or normalize the immune system's activity.

Investigated diseases

Warm Autoimmune Hemolytic Anemia – This is a condition where the immune system mistakenly attacks and destroys the body's own red blood cells, leading to anemia. The destruction of red blood cells occurs at a faster rate than the body can produce them, causing a shortage. Symptoms may include fatigue, shortness of breath, and a pale or yellowish skin tone. The disease progresses as the immune system continues to target red blood cells, which can lead to a decrease in hemoglobin levels. Over time, this can result in increased fatigue and other symptoms related to anemia. The condition is considered rare and can vary in severity among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505321-14-00Protocol codeMOM-M281-006Estimated enrolment111 patientsSponsorJanssen Cilag International

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