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Study of Belimumab versus Placebo for Treatment of Non-infectious Active Cryoglobulinemia Vasculitis in Adult Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on cryoglobulinemia vasculitis, which is a condition where abnormal proteins in the blood cause inflammation of blood vessels. The study will evaluate a medication called belimumab, given as an injection under the skin, compared to a placebo. The purpose is to determine if belimumab is effective in treating people with non-infectious active cryoglobulinemia vasculitis.

The treatment involves receiving rituximab therapy first, followed by either belimumab injections or placebo. Belimumab is given as a 200 mg injection under the skin. The total duration of treatment is 24 weeks. During the study, doctors will monitor how well the treatment works in controlling the symptoms of blood vessel inflammation.

Participants will have regular check-ups to monitor their health and any changes in their condition. The study will look at how well the treatment works in clearing the abnormal proteins from the blood and improving inflammation. Doctors will also track any side effects that may occur during the treatment period.

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

    Initial treatment phase

    You will receive rituximab as initial therapy (1 to 4 infusions) within 6 weeks before starting the main study treatment

    The exact dose will be determined by your doctor

  2. Step 2

    Study medication assignment

    You will be randomly assigned to receive either Benlysta (belimumab) 200 mg or a placebo

    The medication will be given as an injection under the skin (subcutaneous injection)

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Treatment period with corticosteroids

    You will receive oral corticosteroids (prednisone or prednisolone) along with the study medication

    The corticosteroid treatment will continue until week 12

  4. Step 4

    Corticosteroid withdrawal

    At week 12, the corticosteroid treatment will be stopped completely

  5. Step 5

    First evaluation period

    Your response to treatment will be evaluated at week 25

    The doctors will assess if your vasculitis symptoms have improved

  6. Step 6

    Extended follow-up

    You will continue to be monitored until week 48

    Regular assessments will check your clinical response and any side effects

    Blood tests will monitor levels of cryoglobulinemia, rheumatoid factor, and complement

  7. Step 7

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or adverse reactions

    Monthly pregnancy tests will be required for women who can become pregnant

    If you have certain hepatitis B markers, you will need regular liver monitoring throughout the study and for 12 months after treatment ends

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Must provide written informed consent to participate in the study
  • Must have active mixed cryoglobulinemia vasculitis with at least one of these conditions: - Skin, joint, kidney, nerve, brain, digestive, lung, or heart involvement - History of positive blood tests showing specific antibodies and protein markers - Tissue sample showing blood vessel inflammation
  • Must have received Rituximab treatment (a type of medication) within the past 6 weeks
  • Must have a neutrophil count (type of white blood cells) above 1x109/L
  • Must be HIV negative
  • Must have negative hepatitis B tests (HBs Ag and HBc Ab) or meet specific hepatitis monitoring requirements
  • Must have either negative hepatitis C test or show no active virus if previously positive
  • Women who can become pregnant must: - Have a negative pregnancy test at the start - Agree to monthly pregnancy testing - Use effective birth control during the study and for 92 days after
  • Men who can father children must: - Use effective birth control during the study - Continue birth control for 92 days after the last dose

Who cannot join the trial?

14 criteria

  • Previous treatment with belimumab or any other biologic therapy within 6 months before the study
  • Active or chronic infection with hepatitis B or C virus
  • History of severe allergic reactions to biological medications
  • Active tuberculosis or other serious infections requiring treatment
  • Presence of any other severe medical condition that could interfere with study participation
  • Pregnancy or breastfeeding
  • Any form of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Severe kidney disease requiring dialysis
  • History of drug or alcohol abuse within the past year
  • Mental health conditions that could affect ability to comply with study procedures
  • Treatment with another investigational drug within 30 days before the study
  • History of blood clotting disorders or recent major surgery
  • Unstable heart disease or recent heart attack within past 6 months
  • Participation in another clinical trial
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Investigated drugs

  • Belimumab

    is a medication that works by targeting and reducing specific immune system cells that can cause inflammation and damage to blood vessels. It belongs to a class of drugs called monoclonal antibodies. This medication is being studied for treating cryoglobulinemia vasculitis, a condition where abnormal proteins in the blood cause inflammation of blood vessels. Belimumab is already used to treat lupus and may help control the immune system's overactive response in vasculitis.

  • Rituximab

    is mentioned as a previous treatment in the study title. It is also a monoclonal antibody that works by reducing certain types of B cells (immune cells) in the body. While not actively compared in this trial, it's important to note that patients have received this medication before starting either belimumab or placebo.

What is already known about the treatment

Belimumab - A biological medication administered through intravenous infusion or subcutaneous injection that belongs to the class of monoclonal antibodies. It works by targeting and inhibiting B-lymphocyte stimulator (BLyS), a protein that plays a crucial role in the development of abnormal B cells that produce autoantibodies. This medication is primarily used in the treatment of autoimmune conditions, including systemic lupus erythematosus (SLE) and, as being studied in clinical trials, cryoglobulinemia vasculitis. Belimumab helps reduce inflammation and autoimmune activity by decreasing the survival of B cells that contribute to the disease process, potentially leading to improvement in symptoms and disease control.

Investigated diseases

Cryoglobulinemia vasculitis - A rare condition where abnormal proteins called cryoglobulins are present in the blood, causing inflammation of blood vessels. These proteins can clump together when exposed to cold temperatures, leading to reduced blood flow to various parts of the body. The condition affects small and medium-sized blood vessels throughout the body, potentially impacting multiple organs. Common manifestations include skin lesions, joint pain, and weakness. The disease can develop gradually over time, with symptoms varying in intensity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516237-12-00Protocol codeAPHP180351Estimated enrolment52 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).