Iptacopan in Patients With ANCA Associated Vasculitis

May 13, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1181ACH
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1180AAX
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, B1900AWT
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Novartis Investigative Site
  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Novartis Investigative Site
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Novartis Investigative Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Novartis Investigative Site
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2X 1R9
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1R 2J6
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Novartis Investigative Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Novartis Investigative Site
      • Herlev, Denmark, DK-2730
        • Novartis Investigative Site
  • France
      • Angers, France, 49933
        • Novartis Investigative Site
      • Brest, France, 29200
        • Novartis Investigative Site
      • Dijon, France, 21000
        • Novartis Investigative Site
      • Marseille, France, 13005
        • Novartis Investigative Site
      • Paris, France, 75014
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Ludwigshafen, Germany, 67063
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Kirchheim unter Teck, Baden-Wurttemberg, Germany, 73230
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Novartis Investigative Site
    • Caceres
      • Plasencia, Caceres, Spain, 10600
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Pendik
      • Istanbul, Pendik, Turkey (Türkiye), 34899
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Novartis Investigative Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis and Rheumatology Research PLLC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • New York, New York, United States, 10028
        • Northwell Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Matching placebo
Drug: Placebo
Matching placebo administered orally
Drug: Rituximab
Standard of care
Experimental: Iptacopan
LNP023 administered orally
Drug: Iptacopan
LNP023 administered orally
Other Names:
  • LNP023
Drug: Rituximab
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
Time Frame: At Week 48
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
At Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B cell counts
Time Frame: At Week 48
To assess participant's immune status
At Week 48
Total IgG levels
Time Frame: At Week 48
To assess participant's immune status
At Week 48
Time to reach BVAS=0
Time Frame: At Week 24
To assess time to remission through Week 24
At Week 24
Time to major relapse
Time Frame: At Week 48
To assess the effect of iptacopan on disease relapse
At Week 48
Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks
Time Frame: At Week 48
To assess the effect of iptacopan on renal function
At Week 48
Cumulative dose of glucocorticoid (GC)
Time Frame: At Week 48
To assess the effect of iptacopan on GC sparing
At Week 48
Complete remission at week 24
Time Frame: At week 24
Remission is defined as Birmingham Vasculitis Activity Score (BVAS) equal zero. BVAS captures various vasculitis organ manifestations as weighted score describing persistent and new symptoms with higher scores indicating more severe disease.
At week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNP023R12201
  • 2023-510525-15-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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