Iptacopan in Patients With ANCA Associated Vasculitis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

In brief

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.

Key facts

Study ID

NCT06388941

Run by

Novartis Pharmaceuticals

People needed

84

Starts

2024-08-05

Expected to finish

2026-12-30

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed or relapsed GPA and MPA (according to the 2022 ACR/EULAR classification criteria for GPA and MPA) requiring treatment with RTX and GC as per investigator's judgement.
• 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.

You may not qualify if…

• Other systemic disease which constitutes the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severe systemic lupus erythematosus, IgA vasculitis (Purpura Schönlein-Henoch), rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (GBM) disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease.
• 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.

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC — Mesa, Arizona, United States
• Mayo Clinic Rochester — Rochester, Minnesota, 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 — 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

Full record on ClinicalTrials.gov

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