Clinical trials: ANCA-associated Vasculitides
ANCA Associated Vasculitis
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in…
- Trial name
- NCT05962840
- Testing
- Telitacicept
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Chinese SLE Treatment And Research Group
Inflammation, Vasculitis
Analysis of Bronchial Tissue and Fluid in Patients With Wegener's Granulomatosis
This study will collect fluid and tissue samples from the bronchi (air passages to the lungs) of patients with Wegener's granulomatosis for laboratory examination.
- Conditions
- Inflammation, Vasculitis, Wegener's Granulomatosis
- Trial name
- NCT00001541
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Lupus Erythematosus, Inflammatory Myopathy
BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Inflammatory Myopathy, Systemic Sclerosis (SSc), ANCA-associated Vasculitis
- Trial name
- NCT06794008
- Testing
- BCMA-CD19 CAR-T therapy
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University People's Hospital
ANCA Associated Vasculitis, Sjogren's Syndrome
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome
ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.
- Trial name
- NCT04895878
- Where
- France
- Volunteers
- 5 people
- Sponsor
- University Hospital, Montpellier
Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
NUCALA® Special Drug Use Investigation (EGPA, Long-term)
This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in…
- Trial name
- NCT03557060
- Testing
- Nucala
- Where
- Japan
- Volunteers
- 4,115 people
- Sponsor
- GlaxoSmithKline
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
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories
Systemic Lupus Erythematosus, Systemic Scleroderma
Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome
- Trial name
- AutoB-Tetramer (NCT07251179)
- Testing
- blood draw
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Strasbourg, France
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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
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
ANCA Associated Systemic Vasculitis Including Wegener's, Granulomatosis and Microscopic Polyangiitis and
IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.
- Conditions
- ANCA Associated Systemic Vasculitis Including Wegener's, Granulomatosis and Microscopic Polyangiitis and, Renal Limited Vasculitis
- Trial name
- NCT00307645
- Testing
- Cyclophosphamide, Mycophenolate mofetil, Azathioprine
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lupus Nephritis, ANCA-associated Vasculitis
The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined…
- Conditions
- Lupus Nephritis, ANCA-associated Vasculitis, Membranous Nephropathy - PLA2R Induced, IgG4-Related Diseases
- Trial name
- NCT06285279
- Testing
- FKC289
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Nanjing University School of Medicine
Systemic Lupus Erythematosus, Lupus Nephritis
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
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…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- BAH242 (NCT06350110)
- Testing
- CD19- BCMA CAR-T cells
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Essen Biotech
Inflammation, Vasculitis
Steroids and Methotrexate to Treat Systemic Vasculitis
This study will evaluate the safety and effectiveness of prednisone and methotrexate in treating severe Wegener's granulomatosis and other systemic vasculitides.
- Conditions
- Inflammation, Vasculitis, Wegener's Granulomatosis
- Trial name
- NCT00001256
- Testing
- prednisone and methotrexate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome.
- Trial name
- NCT03298061
- Testing
- Mepolizumab, Prednisolone
- Where
- 32 sites in United States, Belgium and 5 more
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis, Pemphigus Vulgaris
Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris…
- Conditions
- Rheumatoid Arthritis, Pemphigus Vulgaris, Granulomatosis With Polyangiitis, Systemic Lupus Erythematosus
- Trial name
- IRIS-RD-01 (NCT06581562)
- Testing
- AB-101, Rituximab, Cyclophosphamide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- IRIS Research and Development, LLC
Wegener's Granulomatosis
Study of One Protein Implicated in Wegener Disease
The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation.
- Trial name
- DAP12WEGENER (NCT01167491)
- Testing
- Physiopathology Endpoint Classification
- Where
- France
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
The objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 in Japanese healthy adult males; and to compare the…
- Trial name
- NCT05988008
- Testing
- CCX168
- Where
- Japan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Amgen