Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-08-05
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iptacopan
LNP023 administered orally
Iptacopan
LNP023 administered orally
Rituximab
Standard of care
Control
Matching placebo
Placebo
Matching placebo administered orally
Rituximab
Standard of care
Interventions
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Iptacopan
LNP023 administered orally
Placebo
Matching placebo administered orally
Rituximab
Standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BVAS assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items at Screening.
* Positive antibody test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) antibodies at Screening or with history of documented evidence of a positive antibody test.
Exclusion Criteria
* Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
* Severe kidney disease defined as estimated glomerular filtration rate (eGFR) \<15 mL/minute/1.73m2, or kidney failure defined as receiving renal replacement therapy such as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidney transplant.
* Received plasma exchange/-pheresis within 12 weeks prior to Screening.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, United States
UCLA Medical Center
Los Angeles, California, 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
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CABA, , Argentina
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Concord, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Innsbruck, Tyrol, Austria
Novartis Investigative Site
Graz, , Austria
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Vienna, , Austria
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Leuven, Vlaams Brabant, Belgium
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Roeselare, West-Vlaanderen, Belgium
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London, Ontario, Canada
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Fleurimont, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Shijiazhuang, Hebei, China
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Zhengzhou, Henan, China
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Beijing, , China
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Shanghai, , China
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Prague, , Czechia
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Aarhus N, , Denmark
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Copenhagen, , Denmark
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Herlev, , Denmark
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Angers, , France
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Brest, , France
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Dijon, , France
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Marseille, , France
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Paris, , France
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Toulouse, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Berlin, , Germany
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Ludwigshafen, , Germany
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Mainz, , Germany
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, , Hungary
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Szeged, , Hungary
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Groningen, , Netherlands
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Plasencia, Caceres, Spain
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Pamplona, Navarre, Spain
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Madrid, , Spain
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Istanbul, Pendik, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom
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Cambridge, , United Kingdom
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Leicester, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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2023-510525-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
CLNP023R12201
Identifier Type: -
Identifier Source: org_study_id
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