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Granulomatosis With Polyangiitis clinical trials

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NCT ID: NCT06350110 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

BAH242
Start date: November 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

NCT ID: NCT06298448 Recruiting - Clinical trials for EGPA - Eosinophilic Granulomatosis With Polyangiitis

eGPA and Local Inflammation Within the Ear, Nose and Throat Area

Start date: February 14, 2024
Phase:
Study type: Observational

Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.

NCT ID: NCT06294236 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

Start date: April 2024
Phase: Phase 1
Study type: Interventional

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

NCT ID: NCT06231498 Not yet recruiting - Clinical trials for Eosinophilic Granulomatosis With Polyangiitis

The Epigenomic Signature of Eosinophilic Granulomatosis With Polyangiitis

EPI-EGPA
Start date: April 2024
Phase:
Study type: Observational

This is a case-control observational study on blood samples. The primary goal of this study is to identify the epigenetic marks that can distinguish patients suffering from Eosinophilic Granulomatosis with Polyangiitis (EGPA) from healthy individuals. The secondary goal is to identify epigenetic or transcriptional marks that can predict if a patient with EGPA will benefit from therapy with Mepolizumab. This study is observational, meaning there will be no alterations of patients' routine clinical care. A blood sample will be drawn for each patient. If the patient will undergo treatment with Mepolizumab (based on routine clinical care), then the blood sample will be drawn before Mepolizumab initiation. The blood samples will be used for genome-wide DNA methylation profiling and for transcriptomic profiling. Healthy individuals as controls for the association study will not be recruited. In fact, the epigenetic and transcriptomic data obtained from EGPA patient blood will be compared against already available genome-wide DNA methylation and transcriptomic profiles of the blood of healthy individuals from previous studies. A total of 300 patients with EGPA will be recruited for the study. The first part of the study, corresponding to the primary goal, will involve all of the 300 patients. The second part of the study, corresponding to the secondary goal, will involve a study population subset consisting of 50 patients.

NCT ID: NCT06230354 Enrolling by invitation - Clinical trials for EGPA - Eosinophilic Granulomatosis With Polyangiitis

Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

RACEMATE
Start date: May 2024
Phase: Phase 2
Study type: Interventional

RACEMATE is a phase 2b, multicentre, randomised, double-blinded, placebo-controlled study designed to explore the efficacy and mechanism of action of tezepelumab in adults with eosinophilic granulomatosis with polyangiitis (EGPA).

NCT ID: NCT06046222 Recruiting - Clinical trials for Churg-Strauss Syndrome

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

NCT ID: NCT05979051 Recruiting - Clinical trials for Eosinophilic Granulomatosis With Polyangiitis

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Start date: November 16, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

NCT ID: NCT05716334 Active, not recruiting - Clinical trials for Microscopic Polyangiitis

Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator

BRAVO
Start date: June 15, 2021
Phase:
Study type: Observational

The goal of this multicentre observational study is to compare the safety and effectiveness of rituximab biosimilars to the originator in Canadian patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), two main forms of ANCA-associated vasculitis (AAV). The main questions it aims to answer are: - Is there a difference in vasculitis control between originator and biosimilar rituximab? - Is there a difference in adverse effects between originator and biosimilar rituximab? - In the Canadian healthcare context, are wait times to receive approval (financial coverage) for rituximab shorter for biosimilars compared to originators? Investigators will perform study assessments (including recording disease activity, damage, and adverse events) at the time of participants' usual clinical care visits, at regular intervals for 2 years after starting rituximab (for induction or maintenance treatment) or switching from an originator to a biosimilar as part of their usual care. Researchers will compare outcomes among participants who have received rituximab originators (from 2018 onwards) or biosimilars as part of their usual care, to see if there are differences in relapses, remission rates, damage, serious infections, serious adverse events, and treatment approval wait times.

NCT ID: NCT05703802 Recruiting - Sepsis Clinical Trials

Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within our workgroup we found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. However, it is unknown if this applies also in humans. By using an ELISA-assay we want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.

NCT ID: NCT05376319 Recruiting - Clinical trials for Microscopic Polyangiitis

PR3-AAV Resilient Remission or PRRR

Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).