Clinical trials: ANCA Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
- Trial name
- NCT07160608
- Testing
- Tarperprumig
- Where
- 57 sites in Argentina, Australia and 12 more
- Volunteers
- 78 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
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
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.
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 (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
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
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.
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
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.
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
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.
ANCA-Associated Vasculitis
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with…
- Trial name
- ADVOCATE (NCT02994927)
- Testing
- Avacopan, Prednisone, Cyclophosphamide
- Where
- 198 sites in United States, Australia and 18 more
- Volunteers
- 331 people
- Sponsor
- Amgen
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
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
Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Iptacopan in Patients With ANCA Associated Vasculitis
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or…
- Trial name
- NCT06388941
- Testing
- Iptacopan, Rituximab
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy…
- Trial name
- NCT05988021
- Testing
- CCX168
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Vasculitis
A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV).
- Trial name
- NCT01363388
- Testing
- CCX168
- Where
- 44 sites in Austria, Belgium and 8 more
- Volunteers
- 67 people
- Sponsor
- Amgen
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