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Smart antibody monitoring could prevent pemphigus Flare-Ups

NCT ID NCT05898308

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a personalized approach to treating pemphigus, a rare blistering skin disease. Instead of waiting for a relapse, doctors will use blood tests to measure specific antibodies and give extra rituximab infusions only when those levels rise. The goal is to prevent flare-ups and reduce the need for steroids. About 133 adults with newly diagnosed moderate-to-severe pemphigus will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 133 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 and ≤ 80 years * Signed Informed Consent Form (or from the family in case of impossibility of patient's consent). * Confirmed newly diagnosed PV or PF, based on the presence of the following: histological features of acantholysis on skin or mucosal biopsy, and deposition of IgG, complement component 3, or both on the keratinocyte membrane detected by direct immunofluorescence on affected skin or mucosa * Presence of moderate-to-severely active disease, defined by an overall PDAI score\> 1554 * Patient able to receive the standard-of-care consisting of corticosteroids (prednisone 1 mg/kg/day PO) and rituximab * Patients must be vaccinated against Covid-19 before study entry. It is recommended that patients are vaccinated against influenza and Streptococcus pneumoniae and have their first injection (Prevenar 13) before study entry. * For women who are not postmenopausal (menopausal: ≥ 12 months of non-therapy-induced amenorrhoea) or surgically sterile (absence of ovaries and/or uterus + bilateral salphingectomy) and who do not plan on having children anymore: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year, during the treatment period and for at least 12 months after the last dose of study treatment. They must have a negative result from a blood beta-HCG test within 1 week prior to randomization Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide. • For men: Surgical sterility or agreement to remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of study treatment and agreement to refrain from donating sperm during this same period. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. * Able to comply with the study protocol, in the investigator's judgment * Patient affiliated with, or beneficiary of a social security (national health insurance) plan Exclusion Criteria: * Non-consenting patient or patient who cannot be followed regularly. * Diagnosis of paraneoplastic pemphigus or evidence of other non-PV or PF autoimmune blistering disease * Contraindication to rituximab marketed as 500 mg concentrate for solution for infusion * Contraindication to prednisone marketed as 20 mg, scored tablet pharmaceutical form * Contraindication to methylprednisolone marketed as 120 mg powder for injectable solution pharmaceutical form * Contraindication to paracetamol marketed as 10 mg/mL solution for infusion pharmaceutical form * Contraindication to dexchlorpheniramine maleate marketed as 5 mg/1mL injectable solution pharmaceutical form * Lack of peripheral venous access * Pregnant or lactating * Significant cardiovascular or pulmonary disease (including obstructive pulmonary disease) * Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude patient participation, including but not limited to nervous system, renal, hepatic, endocrine, malignant, or gastrointestinal disorders * Any concomitant condition that required treatment with oral or systemic corticosteroids within 12 weeks prior to randomization- excluding transitory treatments (such as a corticosteroid therapy prescribed for a few days for an acute infection), and chronic corticosteroid treatments with a prednisone / prednisolone dose ≤20 mg/day, (these latter patients remain eligible for study entry) * Treatment with IV Ig, plasmapheresis, or other similar procedure within 8 weeks prior to randomization * Patients having received immunosuppressive treatment (such as cyclosporine, mycophenolate mofetil, azathioprine given at an effective dose for any other condition than Pemphigus, or any other treatment that might potentially be active on Pemphigus lesions (anti-TNF) within 4 weeks prior to baseline * Treatment with cyclophosphamide within 12 weeks prior to randomization * Patients with positive blood test for HIV * Inherited or acquired severe immune deficiency * Known active infection of any kind (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization. Entry into this study may be reconsidered once the infection has fully resolved. * Patients with a currently treated cancer, including solid tumors, hematologic malignancies, and carcinoma (except basal cell of the skin and squamous cell carcinoma of the skin which can be easily cured with a standard excision ) * Patients with a past history ( \< 5 years) of cancer, including solid tumors, hematologic malignancies, and carcinoma (except complete excision of basal cell of the skin and squamous cell carcinoma of the skin that have been excised and cured) NB: Patients whose cancer is cured and do not have anti-cancer treatment anymore must be referred to an oncologist before entry in the study * Currently active alcohol or drug abuse, or history of alcohol or drug abuse within 24 weeks prior to screening * Major surgery within 4 weeks prior to randomization, excluding diagnostic surgery * Treatment with rituximab or a B cell-targeted therapy (e.g., anti-CD20, anti-CD22, or anti-BLyS) within 12 months prior to randomization * Treatment with a live or attenuated vaccine within 28 days prior to randomization. It is recommended that a patient's vaccination record and the need for immunization prior to study entry be carefully investigated. * Major biological abnormality which in the investigator's judgment, would preclude patient participation, * Positive test results for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) serology at screening * Participation in another interventional clinical trial within 28 days prior to randomization and during the study * Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

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Conditions

The condition(s) this trial relates to.

pemphigus pemphigus foliaceus pemphigus vulgaris skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatologic disease Pemphigus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ap-Hm Hopital Nord

    NOT_YET_RECRUITING

    Marseille, 13915, France

  • Ap-Hm La Timone

    NOT_YET_RECRUITING

    Marseille, 13385, France

  • Ap-Hp Bichat

    NOT_YET_RECRUITING

    Paris, 75018, France

  • Ap-Hp Henri Mondor

    NOT_YET_RECRUITING

    Créteil, 94010, France

  • Ap-Hp Hopital Avicennes

    NOT_YET_RECRUITING

    Bobigny, 93000, France

  • Ap-Hp Hopital Cochin

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Ap-Hp Pitie Salpetriere

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Ap-Hp Saint Louis

    NOT_YET_RECRUITING

    Paris, 75010, France

  • CH NIORT

    RECRUITING

    Niort, 79000, France

  • CHU CAEN

    RECRUITING

    Caen, 14033, France

  • Ch Argenteuil

    RECRUITING

    Argenteuil, 51000, France

  • Ch Dunkerque

    RECRUITING

    Dunkirk, 59385, France

  • Ch Le Mans

    RECRUITING

    Le Mans, 72037, France

  • Chr Orleans

    RECRUITING

    Orléans, 45067, France

  • Chu Amiens

    RECRUITING

    Amiens, 80054, France

  • Chu Angers

    RECRUITING

    Angers, 49100, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, 33076, France

  • Chu Brest

    RECRUITING

    Brest, 29200, France

  • Chu Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63100, France

  • Chu Dijon

    RECRUITING

    Dijon, 21000, France

  • Chu Guadeloupe

    RECRUITING

    Pointe-à-Pitre, 97159, Guadeloupe

  • Chu Lille

    RECRUITING

    Lille, 59037, France

  • Chu Limoges

    RECRUITING

    Limoges, 87000, France

  • Chu Montpellier

    RECRUITING

    Montpellier, 34295, France

  • Chu Nantes

    RECRUITING

    Nantes, 44000, France

  • Chu Reims

    NOT_YET_RECRUITING

    Reims, 51092, France

  • Chu Rennes

    RECRUITING

    Rennes, 35000, France

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

  • Chu Saint-Etienne

    RECRUITING

    Saint-Etienne, 42270, France

  • Chu Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Chu Tours

    RECRUITING

    Tours, 37000, France

  • Gh Le Havre

    RECRUITING

    Le Havre, 76290, France

  • Hcl Edouard Herriot

    NOT_YET_RECRUITING

    Lyon, 69003, France

  • Hcl Lyon Sud

    NOT_YET_RECRUITING

    Pierre-Bénite, 69310, France

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