Clinical trials: Vasculitis, Systemic
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
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.
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
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
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
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
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)
This is a Randomized, Double-Blind, Placebo-Controlled Study designed to assess safety, tolerability, and efficacy of NM8074 in AAV patients when used in combination with Standard of Care (SOC) cyclophosphamide/azathioprine or…
- Trial name
- NCT06226662
- Testing
- NM8074
- Volunteers
- 12 people
- Sponsor
- NovelMed Therapeutics
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.
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
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.
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
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
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
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
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
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Trial name
- NCT07089121
- Testing
- Descartes-08
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cartesian Therapeutics
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
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
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