Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Personalized Maintenance Therapy with Rituximab and Corticosteroids for Patients with Pemphigus

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying pemphigus, a group of rare skin diseases that cause blisters and sores on the skin and mucous membranes. The study will explore a new approach to maintaining treatment for pemphigus by comparing it with the standard treatment. The standard treatment involves the use of rituximab, a medication given through an infusion into the vein, along with corticosteroids, which are drugs that help reduce inflammation.

The purpose of the study is to see if a personalized treatment plan can better prevent the return of pemphigus symptoms over four years compared to the current standard treatment. This personalized approach will use specific markers in the blood, known as anti-desmoglein antibodies, to identify patients who are at a higher risk of their disease returning. These patients will receive maintenance infusions of rituximab based on their risk level.

Participants in the study will receive either the personalized treatment or the standard treatment. The study will monitor the participants over a period to observe the effectiveness of the treatments in reducing the relapse rate of pemphigus. The study aims to provide insights into whether tailoring treatment based on individual risk factors can offer better outcomes for patients with pemphigus.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, social security affiliation, and a confirmed diagnosis of pemphigus vulgaris or pemphigus foliaceus.

    The assessment involves a skin or mucosal biopsy to check for specific histological features and the presence of certain antibodies using direct immunofluorescence.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of rituximab and corticosteroids. Rituximab is given as an intravenous infusion, specifically using a product called MabThera 500 mg concentrate for solution for infusion.

    Corticosteroids, such as prednisone, are taken orally at a dosage of 1 mg per kilogram of body weight per day.

  3. Step 3

    Personalized maintenance therapy

    The study aims to personalize maintenance therapy based on the evolution of specific antibodies related to pemphigus activity. This involves monitoring the levels of anti-desmoglein antibodies.

    Patients identified with a high risk of relapse, based on initial disease severity and antibody levels, may receive additional maintenance infusions of rituximab.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess disease activity and response to treatment. This includes evaluating the Pemphigus Disease Area Index (PDAI) score and antibody levels.

    Follow-up visits are scheduled to ensure the treatment's effectiveness and to adjust the therapy as needed.

  5. Step 5

    End of study

    The study is designed to last until March 2032, with the primary goal of reducing the 4-year relapse rate compared to standard treatment guidelines.

    Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

10 criteria

  • Must be between 18 and 80 years old.
  • Must be part of a social security or national health insurance plan.
  • Must have signed an Informed Consent Form, or a family member must sign if the patient is unable to do so.
  • Must have a confirmed new diagnosis of **Pemphigus Vulgaris (PV)** or **Pemphigus Foliaceus (PF)**. This is based on specific findings from a skin or mucosal biopsy and tests showing certain proteins on the skin or mucosa.
  • Must have a **moderate-to-severely active disease**, which means a score greater than 15 on a specific disease activity scale called the **PDAI score**.
  • Must be able to receive standard treatment, which includes **corticosteroids** (a type of medication) and **rituximab** (a specific drug).
  • Must be vaccinated against **Covid-19** before joining the study. It is also recommended to be vaccinated against **influenza** and **pneumococcus** and to have received the first injection of **Prevenar 13** before starting the study.
  • For women who are not postmenopausal or not sterile: Must agree to remain abstinent or use two reliable methods of birth control during the treatment and for at least 12 months after the last dose. A blood test must show no pregnancy within one week before starting the study. Abstinence is only acceptable if it is the patient's usual lifestyle. Certain methods like calendar or withdrawal are not acceptable.
  • For men: Must be surgically sterile or agree to remain abstinent or use a condom during the treatment and for at least 12 months after the last dose. Must also agree not to donate sperm during this time. Abstinence is only acceptable if it is the patient's usual lifestyle. Certain methods like calendar or withdrawal are not acceptable.
  • Must be able to follow the study rules, as judged by the study doctor.

Who cannot join the trial?

6 criteria

  • Patients who are not diagnosed with **Pemphigus diseases**, which include **Pemphigus Vulgaris (PV)** and **Pemphigus Foliaceus (PF)**, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified in the provided data.
  • Patients who are not identified as having a high risk of relapse based on the initial severity of their disease cannot participate. This is assessed using a score called the **PDAI score**.
  • Patients whose disease activity is not monitored using specific blood tests for **antidesmoglein (Dsg) antibodies** cannot participate. These antibodies are used as markers to check how active the disease is.
  • Patients who do not meet the criteria for the personalized treatment strategy being tested in the study cannot participate.
  • Patients who are not part of the vulnerable population selected for the study cannot participate. This typically includes groups like children, pregnant women, or those with certain disabilities, but specific details are not provided.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Rituximab is a medication used in this trial as part of the standard treatment for pemphigus. It works by targeting specific cells in the immune system that are involved in the disease process, helping to reduce inflammation and prevent further damage to the skin and mucous membranes. Corticosteroids are also part of the standard treatment in this trial. They are used to reduce inflammation and suppress the immune system, which can help control the symptoms of pemphigus and prevent flare-ups. The trial also involves a personalized maintenance therapy approach. This strategy uses the levels of specific antibodies in the blood, known as anti-desmoglein antibodies, to determine the risk of disease relapse. Patients identified as having a high risk of relapse may receive additional infusions of rituximab to help maintain disease control.

What is already known about the treatment

Rituximab – This medication is administered through an intravenous infusion, typically in a hospital or clinical setting. It is currently well-established in medical literature and is used in the treatment of various autoimmune diseases, including pemphigus vulgaris and pemphigus foliaceus. Rituximab works by targeting and depleting B-cells, which are a type of white blood cell involved in the immune response, thereby reducing the production of antibodies that attack the body's own tissues. It is classified as a monoclonal antibody and is often used in combination with corticosteroids to manage symptoms and prevent relapses in patients with pemphigus.

Investigated diseases

  • Pemphigus Vulgaris

    Pemphigus Vulgaris is an autoimmune disease characterized by the formation of blisters and erosions on the skin and mucous membranes. It occurs when the immune system mistakenly attacks proteins in the skin, leading to the separation of skin cells. This results in painful, fluid-filled blisters that can rupture easily. The disease often begins in the mouth and can spread to other areas of the body. Over time, the blisters may become widespread, causing significant discomfort and potential complications if not managed properly.

  • Pemphigus Foliaceus

    Pemphigus Foliaceus is a less severe form of pemphigus that primarily affects the skin, causing superficial blisters and crusty sores. Unlike Pemphigus Vulgaris, it does not typically involve the mucous membranes. The blisters in Pemphigus Foliaceus are more superficial and tend to rupture easily, leading to crusting and scaling. The disease often starts on the face and scalp and can spread to other parts of the body. It progresses with periods of flare-ups and remissions, and the severity can vary among individuals.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514886-21-00Protocol code2020/0424/HPEstimated enrolment133 patientsSponsorCentre Hospitalier Universitaire Rouen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.