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Pemphigus clinical trials

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NCT ID: NCT03790293 Not yet recruiting - Autoimmune Diseases Clinical Trials

Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial

LTFURITUX3
Start date: December 2019
Phase: Phase 3
Study type: Interventional

Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by the production of IgG4 isotype autoantibodies (AC) directed mainly against two proteins involved in interkeratinocyte adhesion: desmoglein 1 (Dsg1 ) and desmoglein 3 (Dsg3) (1-3). The binding of auto-AC on these proteins disrupts their adhesion function, resulting in inter-keratinocyte dysjunction called "acantholysis" responsible for the formation of intraepidermal bubbles. Treatment of pemphigus is typically based on systemic corticosteroids. High doses are usually necessary because of the frequent cortico-resistance of the disease. In recent years, several studies have focused on the treatment of pemphigus with anti-CD20: rituximab. The "Ritux 3" study (NCT00784589), a randomized, multicentre, randomized, non-blind clinical trial involving 90 patients, found that the use of rituximab as first-line therapy in combination with short corticosteroid therapy was extremely effective and that cortisone sparing was thus obtained limited the occurrence of side effects of treatment. On the other hand, this study showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the maintenance of a high rate of complete remission up to the 3rd year of follow-up. Questions remain to explain the long-term action of rituximab, in particular that of the evolution of these auto-reactive B cells (specific DSG) away from lymphocyte reconstitution B, as well as the evolution of auto-AC. anti-DSG and total IgG CAs, so as to ensure that the disappearance of the auto-reactive compartment is not accompanied by a long-term overall immunosuppression (and therefore a possible risk of infection). The immunological changes induced in the long term as well as the precise mechanism of action of these treatments and particularly rituximab which allows a complete remission 5 years after treatment in many patients remain little known.

NCT ID: NCT03780166 Withdrawn - Pemphigus Vulgaris Clinical Trials

A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris

Start date: March 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.

NCT ID: NCT03762265 Terminated - Pemphigus Clinical Trials

A Study of PRN1008 in Patients With Pemphigus

Start date: January 8, 2019
Phase: Phase 3
Study type: Interventional

This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.

NCT ID: NCT03334058 Completed - Pemphigus Vulgaris Clinical Trials

A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus

Start date: October 18, 2017
Phase: Phase 2
Study type: Interventional

The proposed study is an open-label, non-controlled, adaptive-design Phase II study to evaluate the safety, pharmacodynamics, pharmacokinetics, efficacy, and conditions of use (dosage, frequency of administration at maintenance) of ARGX-113 in patients with mild to moderate Pemphigus (Vulgaris or Foliaceus), either newly diagnosed or relapsing. The total study duration for each patient is less than 6 months. It consists of a Screening period, an Induction, a maintenance treatment period followed by a treatment-free Follow-up (FU) period.

NCT ID: NCT03239470 Terminated - Pemphigus Vulgaris Clinical Trials

Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus

Start date: October 10, 2017
Phase: Phase 1
Study type: Interventional

T cells, a type of white blood cell called a lymphocyte, play an important role in the immune system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may provide protection against the development of autoimmune disease. The hope is that these naturally occurring Treg cells can be utilized for the treatment of autoimmune disease and potentially replace the use of chronic immunosuppressive therapies that are associated with multiple side effects. There has been a small study showing safe administration of Tregs with decreased disease activity in patients with insulin-dependent diabetes. Tregs are being studied in lupus, cancer and organ transplantation. This phase I trial will be conducted as an open-label, dose-escalation, multicenter trial in adult participants with active pemphigus.The purpose of this study is to test the safety and effect of Treg therapy in participants who have skin (cutaneous) involvement due to pemphigus.

NCT ID: NCT03177213 Not yet recruiting - Pemphigus Vulgaris Clinical Trials

Serum IL-21 Levels in Patients With Pemphigus Vulgaris

Start date: June 2017
Phase: N/A
Study type: Observational

Pemphigus is severe antigen derived autoimmune bullous skin disorder, the word pemphigus is derived from the Greek word" pemphix " which means blister . Two main clinical variants are known pemphigus vulgaris (PV), and pemphigu foliaceus (PF). (Zenzo .et al., 2015).

NCT ID: NCT03075904 Terminated - Pemphigus Vulgaris Clinical Trials

A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

Start date: July 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

NCT ID: NCT02993133 Completed - Clinical trials for Autoimmune Bullous Dermatose

Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

PEMPA
Start date: December 2016
Phase: Phase 3
Study type: Interventional

The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.

NCT ID: NCT02828163 Completed - Clinical trials for Oral Pemphigus Vulgaris

Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.

NCT ID: NCT02753777 Recruiting - Bullous Pemphigoid Clinical Trials

Autoimmune Blistering Diseases Study

AIBD
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.