Clinical trials: Vasculitis, Systemic
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
Granulomatosis With Polyangiitis, Hemophagocytic Syndrome
Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers
The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male…
- Trial name
- NCT05353179
- Testing
- Meperizumab injection, NUCALA®
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Wegeners Granulomatosis
Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis
The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing steroids, and/or immunosuppressive…
- Trial name
- SPARROW (NCT01446211)
- Testing
- Gusperimus + glucocorticoids, cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids
- Where
- Czechia
- Volunteers
- 4 people
- Sponsor
- Nordic Pharma SAS
Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA)
Special Drug Use-results Survey for Long-term Use（Avacopan）
The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.
- Trial name
- NCT06758271
- Testing
- Avacopan
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
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.
Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)
FASENRA Regulatory Postmarketing Surveillance in Korea
As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by…
- Trial name
- FASENRA rPMS (NCT05091333)
- Where
- 5 sites in South Korea
- Volunteers
- 51 people
- Sponsor
- AstraZeneca
Granulomatosis With Polyangiitis, Microscopic Polyangiitis
BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.
- Trial name
- BIANCA-SC (NCT01598857)
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
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
Antineutrophil Cytoplasmic Antibody Associated Vasculitis
The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects
An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
- Trial name
- NCT05702983
- Testing
- STSA-1002 subcutaneous injection
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
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.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
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
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.
- Trial name
- NCT05197842
- Testing
- BDB-001 injection, Cyclophosphamide, Glucocorticoids
- Where
- 22 sites in China
- Volunteers
- 93 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.
- Trial name
- NCT06004960
- Testing
- [14C]CCX168
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amgen
SLE, Sclerosis
A Study of RD06-04 in Patients With Active Autoimmune Diseases
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by…
- Conditions
- SLE, Sclerosis, ANCA Associated Vasculitis, IIM
- Trial name
- NCT06548620
- Testing
- RD06-04 cell infusion
- Where
- China
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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
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
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.
Wegener's Granulomatosis or Microscopic Polyangiitis
A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis [GPA]) or microscopic polyangiitis.
- Trial name
- NCT02115997
- Testing
- Methylprednisolone, Prednisone, Rituximab
- Where
- 10 sites in India
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.