A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
Mesa
California
UCLA Medical Center
RECRUITING
Los Angeles
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
New York
Northwell Health
RECRUITING
New York
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
La Plata
Australia
Novartis Investigative Site
RECRUITING
Adelaide
Novartis Investigative Site
RECRUITING
Clayton
Novartis Investigative Site
RECRUITING
Concord
Novartis Investigative Site
RECRUITING
Westmead
Austria
Novartis Investigative Site
RECRUITING
Graz
Novartis Investigative Site
RECRUITING
Innsbruck
Novartis Investigative Site
RECRUITING
Vienna
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Novartis Investigative Site
RECRUITING
Roeselare
Canada
Novartis Investigative Site
RECRUITING
Fleurimont
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Québec
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shijiazhuang
Novartis Investigative Site
RECRUITING
Zhengzhou
Denmark
Novartis Investigative Site
RECRUITING
Aarhus N
Novartis Investigative Site
RECRUITING
Copenhagen
Novartis Investigative Site
RECRUITING
Herlev
France
Novartis Investigative Site
RECRUITING
Angers
Novartis Investigative Site
RECRUITING
Brest
Novartis Investigative Site
RECRUITING
Dijon
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
RECRUITING
Kirchheim Unter Teck
Novartis Investigative Site
RECRUITING
Ludwigshafen
Novartis Investigative Site
RECRUITING
Mainz
Novartis Investigative Site
RECRUITING
Munich
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Debrecen
Novartis Investigative Site
RECRUITING
Szeged
Netherlands
Novartis Investigative Site
RECRUITING
Groningen
Spain
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Pamplona
Novartis Investigative Site
RECRUITING
Plasencia
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Istanbul
United Kingdom
Novartis Investigative Site
RECRUITING
Bradford
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Cambridge
Novartis Investigative Site
RECRUITING
Leicester
Novartis Investigative Site
RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2027-10-05
Participants
Target number of participants: 78
Treatments
Experimental: Iptacopan
LNP023 administered orally
Placebo_comparator: Control
Matching placebo
Related Therapeutic Areas
Granulomatosis with Polyangiitis
Vasculitis
Acute Interstitial Pneumonia
Microscopic Polyangiitis
Interstitial Lung Disease
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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