Clinical trials: Granulomatosis With Polyangiitis
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.
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
- Trial name
- CLIPS (NCT06512883)
- Testing
- Benralizumab
- Where
- 15 sites in United States, Brazil and 8 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
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
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
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
Asthma
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic…
- Trial name
- NCT06488703
- Where
- Germany
- Volunteers
- 107,032 people
- Sponsor
- GlaxoSmithKline
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
Eosinophilic Granulomatous Vasculitis
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC)…
- Trial name
- MANDARA (NCT04157348)
- Testing
- Benralizumab, Mepolizumab
- Where
- 50 sites in United States, Belgium and 7 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
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
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
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
Eosinophilic Granulomatosis With Polyangiitis
Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.
- Trial name
- OCEAN (NCT05263934)
- Testing
- Depemokimab, Mepolizumab
- Where
- 63 sites in United States, Argentina and 16 more
- Volunteers
- 163 people
- Sponsor
- GlaxoSmithKline
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
- 46 sites in United States, Argentina and 12 more
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Trial name
- IXchange (NCT03895801)
- Testing
- IFX-1, Glucocorticoid (GC)
- Where
- 76 sites in Belgium, Czechia and 9 more
- Volunteers
- 57 people
- Sponsor
- InflaRx GmbH
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.
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
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
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.
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
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