Iptacopan in Patients With ANCA Associated Vasculitis
A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
2 other identifiers
interventional
84
14 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2024
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedStudy Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
April 24, 2026
April 1, 2026
2.4 years
April 17, 2024
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
At Week 48
Secondary Outcomes (7)
B cell counts
At Week 48
Total IgG levels
At Week 48
Complete remission at week 24
At week 24
Time to reach BVAS=0
At Week 24
Time to major relapse
At Week 48
- +2 more secondary outcomes
Study Arms (2)
Iptacopan
EXPERIMENTALLNP023 administered orally
Control
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, 85202, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Northwell Health
New York, New York, 10028, United States
Novartis Investigative Site
CABA, Buenos Aires, C1180AAX, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, B1900AWT, Argentina
Novartis Investigative Site
CABA, C1181ACH, Argentina
Novartis Investigative Site
Concord, New South Wales, 2139, Australia
Novartis Investigative Site
Clayton, Victoria, 3168, Australia
Novartis Investigative Site
Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site
Graz, 8036, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Leuven, Vlaams Brabant, 3000, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, 8800, Belgium
Novartis Investigative Site
London, Ontario, N6A 5W9, Canada
Novartis Investigative Site
Fleurimont, Quebec, J1H 5N4, Canada
Novartis Investigative Site
Montreal, Quebec, H2X 1R9, Canada
Novartis Investigative Site
Montreal, Quebec, H4J 1C5, Canada
Novartis Investigative Site
Québec, Quebec, G1R 2J6, Canada
Novartis Investigative Site
Shijiazhuang, Hebei, 050000, China
Novartis Investigative Site
Zhengzhou, Henan, 450003, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Prague, 128 08, Czechia
Novartis Investigative Site
Aarhus N, 8200, Denmark
Novartis Investigative Site
Herlev, DK-2730, Denmark
Novartis Investigative Site
Angers, 49933, France
Novartis Investigative Site
Brest, 29200, France
Novartis Investigative Site
Dijon, 21000, France
Novartis Investigative Site
Marseille, 13005, France
Novartis Investigative Site
Paris, 75014, France
Novartis Investigative Site
Toulouse, 31054, France
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany
Novartis Investigative Site
Munich, Bavaria, 81377, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Ludwigshafen, 67063, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032, Hungary
Novartis Investigative Site
Budapest, H-1083, Hungary
Novartis Investigative Site
Szeged, 6725, Hungary
Novartis Investigative Site
Plasencia, Caceres, 10600, Spain
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Istanbul, Pendik, 34899, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
Cambridge, CB2 0QQ, United Kingdom
Related Publications (1)
Brilland B, Riou J, Quemeneur T, Vandenbussche C, Merillon N, Boizard-Moracchini A, Roy M, Despre M, Piccoli GB, Djema A, Henry N, Preisser L, Blanchet O, Gnemmi V, Copin MC, Langlais D, Jeannin P, Blanco P, Delneste Y, Augusto JF; Maine-Anjou Registry Research Group. Identification of Renal Transcripts Associated with Kidney Function and Prognosis in ANCA-Associated Vasculitis. J Am Soc Nephrol. 2026 Jan 1;37(1):131-149. doi: 10.1681/ASN.0000000779. Epub 2025 Jul 9.
PMID: 40632630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 29, 2024
Study Start
August 5, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.