Clinical trial NCT06388941: Iptacopan in Patients With ANCA Associated Vasculitis
Official title: A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Keywords: ANCA-associated vasculitis;
granulomatosis with polyangiitis (GPA);
microscopic polyangiitis (MPA);
LNP023 (iptacopan).
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a randomized, controlled study to evaluate the efficacy and safety of iptacopan in combination with RTX induction therapy for the treatment of newly diagnosed or relapsed patients with active GPA or MPA.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
timeFrame: At Week 48
Secondary outcomes:
measure: B cell counts
timeFrame: At Week 48
measure: Total IgG levels
timeFrame: At Week 48
measure: Complete remission at week 24
timeFrame: At week 24
measure: Time to reach BVAS=0
timeFrame: At Week 24
measure: Time to major relapse
timeFrame: At Week 48
measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks
timeFrame: At Week 48
measure: Cumulative dose of glucocorticoid (GC)
timeFrame: At Week 48
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Northwell Health
state: New York
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Concord
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Fleurimont
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Beijing
country: China
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Aarhus N
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Toulouse 4
country: France
facility: Novartis Investigative Site
city: Kirchheim Unter Teck
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Plasencia
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Pendik Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
References: