Clinical trials: CNS Vasculitis
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
Giant Cell Arteritis
A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)
To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.
- Trial name
- NCT03192969
- Testing
- Abatacept, Glucocorticoid Treatment
- Where
- 99 sites in United States, Australia and 19 more
- Sponsor
- Bristol-Myers Squibb
Giant Cell Arteritis
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell…
- Trial name
- THEIA (NCT04633447)
- Testing
- Guselkumab
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
Giant Cell Arteritis
Assessment of Giant Cell Arteritis Medical Practices in France
The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.
- Trial name
- ARTEMIS (NCT03658889)
- Where
- France
- Volunteers
- 306 people
- Sponsor
- Chugai Pharma France
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
Age-Related Macular Degeneration, Allergies
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and…
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease
- Trial name
- NCT05635266
- Testing
- Specimen sample
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Sanguine Biosciences
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.
Giant Cell Arteritis
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting…
- Trial name
- NCT03202368
- Testing
- Tocilizumab
- Where
- 3 sites in France
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
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
Giant Cell Arteritis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
- Trial name
- NCT03923738
- Testing
- Tocilizumab
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Giant Cell Arteritis
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination…
- Trial name
- NCT03600805
- Testing
- Sarilumab SAR153191, Prednisone
- Where
- 61 sites in United States, Argentina and 19 more
- Volunteers
- 83 people
- Sponsor
- Sanofi
Giant Cell Arteritis
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis…
- Trial name
- NCT02531633
- Testing
- Sirukumab, Prednisone
- Where
- 63 sites in United States, Australia and 11 more
- Volunteers
- 161 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
Giant Cell Arteritis
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid…
- Trial name
- GigAINt (NCT05380453)
- Testing
- Secukinumab 300 mg, s.c.
- Where
- 25 sites in Germany
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Giant Cell Arteritis, Polymyalgia Rheumatica
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics [PK]) and whether it will be safe and tolerable after multiple doses of i.v.
- Trial name
- NCT06130540
- Testing
- Secukinumab
- Where
- 19 sites in United States, Czechia and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals