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New pill aims to tame rare blood vessel disease

NCT ID NCT06388941

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding the oral drug iptacopan to standard therapy (rituximab) helps people with active ANCA vasculitis achieve and maintain remission. About 84 adults with newly diagnosed or relapsed disease will receive either iptacopan or a placebo, plus standard care. The study tracks remission rates, kidney function, and quality of life over 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iptacopan (also called LNP023), a pill taken by mouth
What this could lead to
If it works, this could offer a new treatment option for ANCA vasculitis that helps patients reach and stay in remission with fewer steroid-related side effects.
What could go wrong
This is a mid-stage trial with only 84 participants, so results may not apply to everyone. The drug may not improve remission rates or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis microscopic polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-neutrophil cytoplasm antibodies (ANCA) associated vasculitis

Contacts and locations

Locations

  • Arizona Arthritis and Rheumatology Research PLLC

    Mesa, Arizona, 85202, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, 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, 2730, Denmark

  • Novartis Investigative Site

    Angers, France, 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

    Ludwigshafen, Germany, 67063, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Budapest, 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

    Cambridge, CB2 0QQ, United Kingdom