Clinical trials: ANCA-Associated Vasculitis (AAV)
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
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Trial name
- NCT07089121
- Testing
- Descartes-08
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cartesian Therapeutics
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
This is a phase 2, double-blind, randomized, controlled, multicenter trial evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of 2 VIS954 dosing regimens in patients with moderate to severe acute…
- Trial name
- NCT07904806
- Testing
- VIS954, Standard Of Care (SOC)
- Volunteers
- 75 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Vasculitis
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
- Trial name
- NCT06321601
- Testing
- Avacopan
- Where
- 34 sites in United States, Belgium and 8 more
- Volunteers
- 19 people
- Sponsor
- Amgen
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
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)
This is a Randomized, Double-Blind, Placebo-Controlled Study designed to assess safety, tolerability, and efficacy of NM8074 in AAV patients when used in combination with Standard of Care (SOC) cyclophosphamide/azathioprine or…
- Trial name
- NCT06226662
- Testing
- NM8074
- Volunteers
- 12 people
- Sponsor
- NovelMed Therapeutics
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
Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)
An Exploratory Study of MT-2990 in Patients With AAV
To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV.
- Trial name
- NCT06196905
- Testing
- MT-2990
- Where
- 8 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Tanabe Pharma Corporation
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.
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
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
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
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.
- Trial name
- NCT03712345
- Testing
- IFX-1 low dose, IFX-1 high dose
- Where
- 38 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- InflaRx GmbH
ANCA Associated Vasculitis (AAV)
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with…
- Trial name
- NCT07168161
- Testing
- BDB-001 injection, Cyclophosphamide, Rituximab
- Where
- 65 sites in China
- Volunteers
- 300 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd