Clinical trials: ANCA Associated Vasculitis (AAV)
Lupus Nephritis, Immunoglobulin A Nephropathy
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis …
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- RUBY-3 (NCT05732402)
- Testing
- Povetacicept
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 72 people
- Sponsor
- Alpine Immune Sciences, Inc.
Systemic Lupus Erthematosus, Systemic Vasculitis
Rare AutoImmune SElf-management Programme Development
The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure.
- Conditions
- Systemic Lupus Erthematosus, Systemic Vasculitis, Inflammatory Myositis, Systemic Sclerosis (SSc)
- Trial name
- RAISE (NCT06642870)
- Testing
- Non-interventional study
- Where
- United Kingdom
- Volunteers
- 360 people
- Sponsor
- University of the West of England
SLE, Systemic Sclerosis
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS…
- Conditions
- SLE, Systemic Sclerosis, IIM, NMOSD
- Trial name
- NCT06775912
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathy, ANCA-Associated Vasculitis (AAV)
- Trial name
- NCT06941129
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage.
- Conditions
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Sjogren Syndrome, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06828042
- Testing
- anti-CD19 CAR T cell therapy
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Peking University Third Hospital
SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07315087
- Testing
- QT-019C
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies
Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation.
- Trial name
- NALVANCA (NCT07636655)
- Testing
- systematic collection of additional biological samples (blood volume), BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Nantes University Hospital
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07305116
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
ANCA Associated Vasculitis (AAV)
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
- Trial name
- NCT06868290
- Testing
- Rapcabtagene autoleucel, Active Comparator, Glucocorticoids
- Where
- 39 sites in United States, Brazil and 6 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Granulomatosis With Polyangiitis
The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach
This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely.
- Trial name
- TAPIR (NCT01940094)
- Testing
- 5 mg Prednisone, 0 mg Prednisone
- Where
- 9 sites in United States, Canada
- Volunteers
- 159 people
- Sponsor
- University of Pennsylvania
Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS)
The ANCA Vasculitis Questionnaire (AAV-PRO©)
The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO).
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS), Granulomatosis With Polyangiitis (Wegener's) (GPA), Wegener Granulomatosis (WG)
- Trial name
- AAV-PRO (NCT02507024)
- Testing
- Online questionnaire
- Where
- 2 sites in United States
- Volunteers
- 280 people
- Sponsor
- University of Pennsylvania
ANCA-associated Vasculitis
Avacostar - (PASS)
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a…
- Trial name
- Avacostar (NCT05897684)
- Where
- 35 sites in Germany, United Kingdom
- Volunteers
- 507 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
ANCA Associated Vasculitis (AAV), Polyangiitis (GPA)
Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment in Cases of ANCA Reappearance in Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
The PREP-ANCA study seeks to establish a more personalized treatment strategy for ANCA-associated vasculitides by assessing the efficacy of pre-emptive rituximab administration upon ANCA repositivity in preventing relapses in…
- Conditions
- ANCA Associated Vasculitis (AAV), Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
- Trial name
- PREP-ANCA (NCT07451847)
- Testing
- Rituximab
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07507201
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
ANCA Associated Vasculitis
the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis
1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy; 2.
- Trial name
- NCT04923074
- Testing
- diffusion tensor imaging(DTI) evaluation
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
ANCA-Associated Vasculitis
Defining Immune Tolerance in ANCA-associated Vasculitis (AAV)
The goal of the study is to find biological markers (certain proteins or cellular markers found in a blood test) that will inform doctors which patients diagnosed with ANCA-associated vasculitis (AAV) are most likely to be able…
- Trial name
- AAV (NCT01934504)
- Testing
- Venipuncture for blood sample collection
- Where
- 3 sites in United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
- Trial name
- AVASET (NCT06072482)
- Testing
- Avacopan, Standard of Care
- Where
- 83 sites in United States, Czechia and 5 more
- Volunteers
- 300 people
- Sponsor
- Amgen
ANCA-Associated Vasculitis (AAV)
Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement
ANCA-associated vasculitis (AAV) is a rare auto-immune disease, with high mortality in the absence of treatment. There is still an unmet need to define new treatment strategies to reduce drug side effects, as well as to reverse…
- Trial name
- REVERSE (NCT07373262)
- Testing
- Avacopan
- Where
- 30 sites in France
- Volunteers
- 130 people
- Sponsor
- University Hospital, Toulouse