PemphigusPhase 4RITUX4NCT05898308

Comparison of a Personalized Maintenance Therapy With the Standard Treatment in Pemphigus

A Phase 4 study testing RiTUXimab Injection in people with Pemphigus and Dermatologic Disease, run by University Hospital, Rouen at 34 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pemphigus, Dermatologic Disease
What is being tested?: RiTUXimab Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 34 sitesin 2 countries
Study dates: 4 Dec 2024to 1 May 2032
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

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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)

Trial locations and contacts

34 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Florian VALLIN contact

+33232888265

florian.vallin@chu-rouen.fr

Country

City, postcode or hospital

Sites recruiting now only

34 sites in 2 countries

France33 sites, 33 recruiting

Chu Amiens
Amiens, 80054
Guillaume Chaby, 03 22 45 56 69, Chaby.Guillaume@chu-amiens.fr
Guillaume Chaby
Recruiting
Chu Angers
Angers, 49100
Clémence Berthin, 02 41 35 34 19, Clemence.berthin@chu-angers.fr
Clémence Berthin
Recruiting
Ch Argenteuil
Argenteuil, 51000
Emmanuel Mahe, 01 34 23 28 80, Emmanuel.mahe@ch-argenteuil.fr
Emmanuel Mahe
Recruiting
Ap-Hp Hopital Avicennes
Bobigny, 93000
Frédéric Caux, 01 48 95 51 89, frederic.caux@aphp.fr
Frédéric Caux
Not yet recruiting
Chu Bordeaux
Bordeaux, 33076
Anne Pham-Ledard, 05 57 65 64 32, anne.pham-ledard@chu-bordeaux.fr
Anne Pham-Ledard
Recruiting
Chu Brest
Brest, 29200
Claire Abasq, 02.98.22.33.15, claire.abasq@chu-brest.fr
Claire Abasq
Recruiting
CHU CAEN
Caen, 14033
Cécile Morice, 02 31 27 25 10, morice-c@chu-caen.fr
Cécile Morice
Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63100
Michel D'Incan, 04 73 75 05 50, mdincan@chu-clermontferrand.Fr
Michel D'Incan
Recruiting
Ap-Hp Henri Mondor
Créteil, 94010
Saskia Oro, 01 49 81 25 01, saskia.oro@aphp.fr
Saskia Oro
Not yet recruiting
Chu Dijon
Dijon, 21000
Christophe Bedane, 05 55 05 64 30, christophe.bedane87@orange.fr
Christophe Bedane
Recruiting
Ch Dunkerque
Dunkirk, 59385
Sophie Duvert-Lehembre, 03 28 28 51 74, Sophie.duvert-Lehembre@ch-dunkerque.fr
Sophie Duvert-Lehembre
Recruiting
Gh Le Havre
Le Havre, 76290
Noémie Litrowski, 02 32 73 33 28, Noemie.litrowski@ch-havre.fr
Noémie Litrowski
Recruiting
Ch Le Mans
Le Mans, 72037
Hervé Maillard, 02 43 43 43 58, hmaillard@ch-lemans.fr
Hervé Maillard
Recruiting
Chu Lille
Lille, 59037
Sophie Duvert-Lehembre, 03 20 44 48 68, Sophie.duvert-Lehembre@ch-dunkerque.fr
Sophie Duvert-Lehembre
Recruiting
Chu Limoges
Limoges, 87000
Salomé Fourmond, 07 60 36 14 66, Salome.FOURMOND@chu-limoges.fr
Salomé Fourmond
Recruiting
Hcl Edouard Herriot
Lyon, 69003
Denis Julien, 04 72 11 72 11, denis.jullien@chu-lyon.fr
Denis Julien
Not yet recruiting
Ap-Hm La Timone
Marseille, 13385
Marie-Aleth Richard, 04 91 74 47 08, marie-aleth.richard@ap-hm.fr
Marie-Aleth Richard
Not yet recruiting
Ap-Hm Hopital Nord
Marseille, 13915
Emmanuel Delaporte, 04 91 96 43 09, Emmanuel.delaporte@ap-hm.fr
Emmanuel Delaporte
Not yet recruiting
Chu Montpellier
Montpellier, 34295
Olivier Dereure, 04 67 33 69 06, o-dereure@chu-montpellier.fr
Olivier Dereure
Recruiting
Chu Nantes
Nantes, 44000
Gaelle Querreux, 02 40 08 31 16, gaelle.quereux@chu-nantes.fr
Gaelle Querreux
Recruiting
CH NIORT
Niort, 79000
Ingrid Kupfer, 05 49 78 23 91, Ingrid.kupfer@ch-niort.fr
Ingrid Kupfer
Recruiting
Chr Orleans
Orléans, 45067
Raphaelle Binois, 02 38 74 48 53, Raphaelle.binois@chr-orleans.fr
Raphaelle Binois
Recruiting
Ap-Hp Saint Louis
Paris, 75010
Jean-David Bouaziz, 01 42 49 99 61, jean-david.bouaziz@aphp.fr
Jean-David Bouaziz
Not yet recruiting
Ap-Hp Pitie Salpetriere
Paris, 75013
Stéphane Barete, 01 56 01 79 00
Stéphane Barete
Not yet recruiting
Ap-Hp Hopital Cochin
Paris, 75014
Nicolas Dupin, 01 58 41 42 43, nicolas.dupin@cch.aphp.fr
Nicolas Dupin
Not yet recruiting
Ap-Hp Bichat
Paris, 75018
Catherine Picard-Dahan, 01 40 25 82 40, catherine.picard-dahan@aphp.fr
Catherine Picard-Dahan
Not yet recruiting
Hcl Lyon Sud
Pierre-Bénite, 69310
Sébastien Debarbieux, 04 78 86 33 33, sebastien.debarbieux@chu-lyon.fr
Sébastien Debarbieux
Not yet recruiting
Chu Reims
Reims, 51092
Manuelle-Anne Viguier, 03 10 73 66 76
Manuelle-Anne Viguier
Not yet recruiting
Chu Rennes
Rennes, 35000
Clémence Saillard, 02 99 28 43 49, clemence.saillard@chu-rennes.fr
Clémence Saillard
Recruiting
Chu Rouen
Rouen, 76031
Pascal Joly, 02 32 88 30 57, pascal.joly@chu-rouen.fr
Pascal Joly
Recruiting
Chu Saint-Etienne
Saint-Etienne, 42270
Jean-Luc Perrot, 04 77 82 85 08, j.luc.perrot@chu-st-etienne.fr
Jean-Luc Perrot
Recruiting
Chu Toulouse
Toulouse, 31059
Marion Marcaillou, 05.65.77.81.07, Marcaillou.m@chu-toulouse.fr
Marion Marcaillou
Recruiting
Chu Tours
Tours, 37000
Emmanuelle Lebidre, 02 47 47 87 73, e.lebidre@chu-tours.fr
Emmanuelle Lebidre
Recruiting

Other trials in France

Guadeloupe1 site, 1 recruiting

Chu Guadeloupe
Pointe-à-Pitre, 97159
Nadège Cordel, 590 590 8914 86, nadege.cordel@chu-guadeloupe.fr
Nadège Cordel
Recruiting

Other trials in Guadeloupe

About this study

Official title: Comparison of a Personalized Maintenance Therapy Based on the Evolution of Anti-desmoglein Antibodies as Biomarkers of Pemphigus Subclinical Activity, With the Standard Treatment (Rituximab + Corticosteroids) in Pemphigus

Pemphigus diseases are life-threatening chronic autoimmune blistering diseases characterized by split formation within the epidermis and surface-close epithelia accompanied by acantholysis. Autoantibodies (Abs) are mainly directed against two structural proteins of the epidermal/epithelial desmosome, desmoglein (Dsg) 1 and Dsg3. Two main pemphigus variants can be differentiated, pemphigus vulgaris (PV), and pemphigus foliaceus (PF). Diagnosis of PV and PF is based on the combination of the clinical picture, histological picture of acantholysis, direct immunofluorescence microscopy (DIF) of a perilesional biopsy and serology.

The present "Ritux 4" trial is the fourth academic study with the French study group on auto immune bullous skin diseases (Groupe Bulle) to assess the use of rituximab in auto immune bullous skin diseases, in particular pemphigus. The 3 previous trials have been published in outstanding Journals (N Engl J Med 2007, Science Transl Med 2013, The Lancet 2017 and 2020), and have led to the approval of rituximab in pemphigus by the FDA in 2018 and EMA in 2019. In addition, an industry-sponsored trial testing rituximab versus mycophenolate mofetil in pemphigus, that the investigators have largely contributed to design has been very recently accepted for publication in the N Engl J Med (2021).

The investigator hypothesize that a maintenance therapy using an infusion of 1g of rituximab at Month 6 in patients whose anti-Dsg Abs have not sufficiently decreased at Month 3 after the initial cycle of rituximab (persistence of anti-Dsg1 Abs> 20 UI/ml and/or anti-Dsg3 Abs> 130 UI/ml), and or had an initial PDAI score >45 ( first year of follow-up), and the re-treatment with 1g of rituximab of patients whose anti Dsg Abs re-increase during the evolution of pemphigus after the initial cycle of rituximab (anti-Dsg1 Abs> 20 IU/ml, anti-Dsg3 Abs> 50 UI/ml), could be effective in preventing the occurrence of relapses, thus avoiding to restart a CS treatment, and would provide benefit as compared with the current treatment strategy of retreating patients with 2 g of rituximab (1g at Day0 and Day14) combined with oral CS patients, once a clinical relapse occurs.

Conditions: Pemphigus, Dermatologic Disease
Being tested: RiTUXimab Injection
Keywords: Pemphigus, Rituximab, Biomarkers, Personalized medicine
Medical subject headings: Pemphigus, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RiTUXimab InjectionDrug
Patients assigned to the "personalized maintenance treatment" will be treated by additional RITUXIMAB injection depending on anti-Dsg Abs levels.

Study groups in NCT05898308
Study group	Role	What they receive
"standard-of-care" arm	No intervention	Patients will be initially treated according to the French guidelines (PNDS) based on the Ritux-3 regimen: 1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months. The prednisone dose could be increased up to 1.5 mg/kg/day in patients who do not achieve disease control with the initial 1 mg/kg/day dose.
"personalized maintenance treatment" arm	Experimental	Patients will be treated with the same regimen (1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months), which will then be adapted according to the evolution of anti-Dsg Abs: During the initial phase of treatment: patients i) whose serum anti-Dsg Abs have not sufficiently decreased ii) and/or those who initially had a severe pemphigus (at the inclusion visit) defined by a PDAI score > 45) will receive 1 g of rituximab at Month 6 ; Beyond the second year from Month 22 (4 months after the Month 18 infusion of 500 mg of rituximab) until the end of the study: patients whose anti-Dsg3 Abs re-increase >50 UI/ml and/or anti-Dsg1Abs re-increase>20 UI/ml) will receive 1 g of rituximab. A maximum of 2 additional maintenance infusions of rituximab per year will be allowed during the study. Receives: Drug: RiTUXimab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of relapses/ flares by patient-year, defined according to the pemphigus consensus statement
by the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a patient who has achieved disease control.
Unit : /patient/year
Measured: 7.5 years

Secondary outcomes (9)

Number of patients-years of additional rituximab infusions to avoid one relapse by year (Number needed to treat, NNT).
Unit: none (ratio of variables with the same dimension)
Measured: 7.5 years
Time to disease flare/ relapse
Unit : years
Measured: 7.5 years
Cumulative duration of complete remission during the study
Unit : % of the time
Measured: 7.5 years
Number of maintenance infusions of 2 g of rituximab per patient-year
Unit: /patient/year
Measured: 7.5 years
Cumulative dose of rituximab by patient-year
Unit : g/patient/year
Measured: 7.5 years
blood leukocytes (measured at D15, M1, then every 3 month from M3 to M48)
Unit : count/mL
Measured: 7.5 years
anti-Dsg1 IgG measured by ELISA (measured at D15, M1, M2, then every 3 month from M3 to M48)
Unit : UI/mL
Measured: 7.5 years
anti-Dsg3 IgG measured by ELISA (measured at D15, M1, M2, then every 3 month from M3 to M48
Unit : UI/mL
Measured: 7.5 years
Quality of life, using the French version of bullous specific QOL questionnaire
Measured at M1, M2, every 3 months from M3 to M48, averaged on all follow-up visits (area under curve) Unit : ABQOL/TABQOL points
Measured: 7.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 20241 May 2032

First posted12 Jun 2023
Study start4 Dec 2024
Primary completion1 May 2032 (estimated)
Study completion1 May 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PemphigusStudies of the same condition, open and under way.
More trials run by University Hospital, RouenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In both arms, patients will be initially treated according to the French guidelines (PNDS) based on the Ritux-3 regimen: 1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months. "standard-of-care" arm will be treated as mentioned above. "personalized maintenance treatment" arm will be treated with the same regimen, adapted according to the evolution of anti-Dsg Abs: During the initial phase of treatment: patients i) whose serum anti-Dsg Abs have not sufficiently decreased ii) and/or those who initially had a severe pemphigus (at the inclusion visit) defined by a PDAI score \> 45) will receive 1 g of rituximab at Month 6 ; the second year from Month 22 (4 months after the Month 18 infusion of 500 mg of rituximab) until the end of the study: patients whose anti-Dsg3 Abs re-increase \>50 UI/ml and/or anti-Dsg1Abs re-increase\>20 UI/ml) will receive 1 g of rituximab.
Masking: None (open label)
Enrolment: 133 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05898308
Sponsor's protocol ID: 2020/0424/HP
Acronym: RITUX4
Status last verified: Feb 2026
First submitted: 26 May 2023
Last updated: 20 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Florian VALLIN

+33232888265

florian.vallin@chu-rouen.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Pemphigus Vulgaris
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Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents
Disasters, Disaster Preparedness
Not yet recruitingEarly Phase 1
Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris
Pemphigus Vulgaris, Rituximab (RTx)
RecruitingEarly Phase 1
A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease
Hailey Hailey Disease, Skin Diseases
Active, not recruitingPhase 3
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Pemphigus, Steroid-resistant Pemphigus

All Pemphigus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Personalized Maintenance Therapy Based on the Evolution of Anti-desmoglein Antibodies as Biomarkers of Pemphigus Subclinical Activity, With the Standard Treatment (Rituximab + Corticosteroids) in Pemphigus
ClinicalTrials.gov ID: NCT05898308
Acronym / sponsor ID: RITUX4 / 2020/0424/HP
Conditions: Pemphigus, Dermatologic Disease
Keywords: Pemphigus, Rituximab, Biomarkers, Personalized medicine
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 133 participants (estimated)
Lead sponsor: University Hospital, RouenUniversity, hospital or other
Study start: 4 Dec 2024 (actual)
Primary completion: 1 May 2032 (estimated)
Study completion: 1 May 2032 (estimated)
First posted: 12 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: In both arms, patients will be initially treated according to the French guidelines (PNDS) based on the Ritux-3 regimen: 1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months. "standard-of-care" arm will be treated as mentioned above. "personalized maintenance treatment" arm will be treated with the same regimen, adapted according to the evolution of anti-Dsg Abs: During the initial phase of treatment: patients i) whose serum anti-Dsg Abs have not sufficiently decreased ii) and/or those who initially had a severe pemphigus (at the inclusion visit) defined by a PDAI score > 45) will receive 1 g of rituximab at Month 6 ; the second year from Month 22 (4 months after the Month 18 infusion of 500 mg of rituximab) until the end of the study: patients whose anti-Dsg3 Abs re-increase >50 UI/ml and/or anti-Dsg1Abs re-increase>20 UI/ml) will receive 1 g of rituximab.

Arm	Type	Receives
"standard-of-care" arm	No intervention	–Patients will be initially treated according to the French guidelines (PNDS) based on the Ritux-3 regimen: 1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months. The prednisone dose could be increased up to 1.5 mg/kg/day in patients who do not achieve disease control with the initial 1 mg/kg/day dose.
"personalized maintenance treatment" arm	Experimental	Drug: RiTUXimab InjectionPatients will be treated with the same regimen (1000 mg of rituximab on Day1-Day14, and 500 mg at Month 12 and Month 18, plus oral prednisone 1 mg/kg/day initially, with the aim to stop prednisone after 6 months), which will then be adapted according to the evolution of anti-Dsg Abs: During the initial phase of treatment: patients i) whose serum anti-Dsg Abs have not sufficiently decreased ii) and/or those who initially had a severe pemphigus (at the inclusion visit) defined by a PDAI score > 45) will receive 1 g of rituximab at Month 6 ; Beyond the second year from Month 22 (4 months after the Month 18 infusion of 500 mg of rituximab) until the end of the study: patients whose anti-Dsg3 Abs re-increase >50 UI/ml and/or anti-Dsg1Abs re-increase>20 UI/ml) will receive 1 g of rituximab. A maximum of 2 additional maintenance infusions of rituximab per year will be allowed during the study.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RiTUXimab InjectionPatients assigned to the "personalized maintenance treatment" will be treated by additional RITUXIMAB injection depending on anti-Dsg Abs levels.	Drug	"personalized maintenance treatment" arm

Primary outcome

Number of relapses/ flares by patient-year, defined according to the pemphigus consensus statement
Time frame: 7.5 years
by the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a patient who has achieved disease control. Unit : /patient/year

9 secondary outcomes

Number of patients-years of additional rituximab infusions to avoid one relapse by year (Number needed to treat, NNT).
Time frame: 7.5 years
Time to disease flare/ relapse
Time frame: 7.5 years
Cumulative duration of complete remission during the study
Time frame: 7.5 years
Number of maintenance infusions of 2 g of rituximab per patient-year
Time frame: 7.5 years
Cumulative dose of rituximab by patient-year
Time frame: 7.5 years
blood leukocytes (measured at D15, M1, then every 3 month from M3 to M48)
Time frame: 7.5 years
anti-Dsg1 IgG measured by ELISA (measured at D15, M1, M2, then every 3 month from M3 to M48)
Time frame: 7.5 years
anti-Dsg3 IgG measured by ELISA (measured at D15, M1, M2, then every 3 month from M3 to M48
Time frame: 7.5 years
Quality of life, using the French version of bullous specific QOL questionnaire
Time frame: 7.5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Florian VALLIN contact

+33232888265

florian.vallin@chu-rouen.fr

Pascal JOLY principal investigator

University Hospital, Rouen

34 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RiTUXimab Injection in people with Pemphigus and Dermatologic Disease, run by University Hospital, Rouen at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florian VALLIN (+33232888265, florian.vallin@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of relapses/ flares by patient-year, defined according to the pemphigus consensus statement (time frame: 7.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.