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Iptacopan treatment for patients with ANCA-associated vasculitis

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

PHASE2 · Novartis · NCT06388941

This study is testing if a new treatment called iptacopan, combined with rituximab, can help people with active ANCA-associated vasculitis feel better and stay in remission compared to standard care.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment78 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionsrituximab
Locations44 sites (Mesa, Arizona and 43 other locations)
Trial IDNCT06388941 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of iptacopan in combination with rituximab for patients with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). It is a randomized, controlled study comparing iptacopan to standard of care to induce and maintain remission in these patients. The trial will also assess the impact of iptacopan on disease relapses, renal function, proteinuria, glucocorticoid side effects, immune status, and quality of life.

Who should consider this trial

Good fit: Ideal candidates include individuals who are newly diagnosed or experiencing a relapse of GPA or MPA and require treatment with rituximab.

Not a fit: Patients with other systemic diseases or conditions that are the primary illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for inducing and maintaining remission in patients with ANCA-associated vasculitis.

How similar studies have performed: Other studies have shown promise in treating ANCA-associated vasculitis with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Mesa, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Anti-Neutrophil Cytoplasm Antibodies Associated Vasculitis, ANCA-associated vasculitis, granulomatosis with polyangiitis, microscopic polyangiitis, LNP023.

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.