Clinical Research Directory
Browse clinical research sites, groups, and studies.
Iptacopan in Patients With ANCA Associated Vasculitis
Sponsor: Novartis Pharmaceuticals
Summary
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 microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL.
Official title: A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2024-08-05
Completion Date
2026-12-30
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Iptacopan
LNP023 administered orally
Placebo
Matching placebo administered orally
Rituximab
Standard of care
Locations (47)
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Northwell Health
New York, New York, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Concord, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Fleurimont, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Aarhus N, Denmark
Novartis Investigative Site
Herlev, Denmark
Novartis Investigative Site
Angers, France
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Dijon, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Ludwigshafen, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Plasencia, Caceres, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Istanbul, Pendik, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Cambridge, United Kingdom