Clinical trials: Systemic Vasculitis
Electrocardiography
A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF).
- Trial name
- NCT05988034
- Testing
- Avacopan, Moxifloxacin
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Amgen
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.
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
Eosinophilic Granulomatosis With Polyangiitis
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
- Trial name
- NCT05979051
- Testing
- SHR-1703, Mepolizumab Injection
- Where
- 2 sites in China
- Volunteers
- 166 people
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
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
Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan
Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels.
- Trial name
- MARS (NCT04551989)
- Where
- 34 sites in Japan
- Volunteers
- 118 people
- Sponsor
- GlaxoSmithKline
ANCA-associated Vasculitis
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
- Trial name
- NCT02222155
- Testing
- CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids, CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
- Where
- 43 sites in United States, Canada
- Volunteers
- 42 people
- Sponsor
- Amgen
Vasculitis
Belimumab in Remission of VASculitis
The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or…
- Trial name
- BREVAS (NCT01663623)
- Testing
- Belimumab 10 mg/kg, Azathioprine
- Where
- 89 sites in United States, Australia and 18 more
- Volunteers
- 106 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
SLE (Systemic Lupus), Systemic Sclerosis
Clinical Study on Targeted CD19 or 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 CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Wegener's Granulomatosis
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.
- Trial name
- NCT00530075
- Testing
- Gusperimus
- Where
- 7 sites in Czechia, Denmark and 4 more
- Volunteers
- 45 people
- Sponsor
- Nippon Kayaku Co., Ltd.
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
Vasculitis, Systemic Lupus Erythematosus (SLE)
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
- Trial name
- NCT05984251
- Testing
- CCX168
- Where
- Switzerland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Churg-Strauss Syndrome
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment…
- Trial name
- NCT02020889
- Testing
- Mepolizumab
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 136 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Sjogren's Syndrome (SS), Inflammatory Myopathy
- Trial name
- NCT07123519
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- 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 Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
Phase Ib Study of SC Milatuzumab in SLE
Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System
- Trial name
- NCT01845740
- Testing
- milatuzumab
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Gilead Sciences
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
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as…
- Conditions
- Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- Trial name
- ROSY-F (NCT07444567)
- Testing
- Benralizumab
- Where
- 47 sites in United States, Argentina and 12 more
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE)
EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study
Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain…
- Conditions
- Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE), Cognitive Impairment
- Trial name
- NCT07281105
- Testing
- EG-501
- Where
- 3 sites in United States
- Volunteers
- 131 people
- Sponsor
- Evergreen Therapeutics, Inc.