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New drug could tame lupus kidney flares

NCT ID NCT05268289

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This study tests whether adding the drug iptacopan to standard treatment helps people with active lupus nephritis (kidney inflammation caused by lupus) achieve better kidney function and fewer flares. About 240 adults with confirmed lupus nephritis will receive either iptacopan or a placebo for 52 weeks. The main goal is to see if more people reach complete kidney response by week 24.

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)
What this could lead to
If successful, this could lead to a new treatment option for lupus nephritis that helps control kidney inflammation and reduces the need for high-dose steroids.
What could go wrong
This is an early Phase 2 trial with only 240 participants, so results may not apply to everyone. The drug may not work better than standard care, and there are risks like infections due to immune suppression.

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

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Sep 2028

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 to 100 years

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: Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS. eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study. First presentation or flare of lupus nephritis. Exclusion Criteria: Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening. Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy. Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease. Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment) Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

lupus nephritis proteinuria systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AKDHC Medical Research ServicesLLC

    WITHDRAWN

    Phoenix, Arizona, 85016, United States

  • Allegheny Health Network

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15212, United States

  • Brigham and Womens Hosp Harvard Med School

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dallas Nephrology Associates

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75204, United States

  • FDI Clinical Research

    RECRUITING

    San Juan, 00927, Puerto Rico

  • Florida Kidney Physicians

    RECRUITING

    Riverview, Florida, 33578, United States

  • Florida Kidney Physicians

    RECRUITING

    Riverview, Florida, 33578, United States

  • Johns Hopkins Hospital

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Fontana

    WITHDRAWN

    Fontana, California, 92335, United States

  • Loma Linda University

    ACTIVE_NOT_RECRUITING

    San Bernardino, California, 92408, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    WITHDRAWN

    Rochester, Minnesota, 55905, United States

  • Nep Assoc of Northern Illinois

    COMPLETED

    Hinsdale, Illinois, 60521, United States

  • Nephrology Associates Of Central FL

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32806, United States

  • Novartis Investigative Site

    WITHDRAWN

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    WITHDRAWN

    San Luis, D5700CGQ, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Santa Fe, S3000EPV, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Salvador, Estado de Bahia, 40150 150, Brazil

  • Novartis Investigative Site

    COMPLETED

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Juiz de Fora, Minas Gerais, 36010 570, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Barretos, São Paulo, 14784 400, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 01308-050, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    COMPLETED

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    COMPLETED

    Nanning, Guangxi, 530022, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yinchuan, Ningxia, 750004, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Shenzhen, 518036, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bogota, Cundinamarca, 111411, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    COMPLETED

    Montería, 230004, Colombia

  • Novartis Investigative Site

    COMPLETED

    Marseille, 13005, France

  • Novartis Investigative Site

    RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    WITHDRAWN

    Paris, 75015, France

  • Novartis Investigative Site

    WITHDRAWN

    Strasbourg, 67091, France

  • Novartis Investigative Site

    WITHDRAWN

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Ludwigshafen, Germany, 67063, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    RECRUITING

    Braunschweig, Lower Saxony, 38126, Germany

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 51109, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Mainz, 55131, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    WITHDRAWN

    Ahmedabad, Gujarat, 380015, India

  • Novartis Investigative Site

    RECRUITING

    Kozhikode, Kerala, 673008, India

  • Novartis Investigative Site

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    WITHDRAWN

    Vellore, Tamil Nadu, 632 004, India

  • Novartis Investigative Site

    RECRUITING

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    RECRUITING

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    WITHDRAWN

    Puducherry, 607402, India

  • Novartis Investigative Site

    WITHDRAWN

    Ashkelon, 7830604, Israel

  • Novartis Investigative Site

    WITHDRAWN

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    WITHDRAWN

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Kuantan, Pahang, 25100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Taiping, Perak, 34000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Selangor Darul Ehsan, 68100, Malaysia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Tampico, Tamaulipas, 89440, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    COMPLETED

    Aguascalientes, 20230, Mexico

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Veracruz, 91900, Mexico

  • Novartis Investigative Site

    RECRUITING

    Makati City, National Capital Region, 1218, Philippines

  • Novartis Investigative Site

    WITHDRAWN

    Iloilo City, 5000, Philippines

  • Novartis Investigative Site

    RECRUITING

    Quezon, 1102, Philippines

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Carnaxide, 2799-523, Portugal

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    WITHDRAWN

    Porto, 4200 319, Portugal

  • Novartis Investigative Site

    RECRUITING

    Vila Nova de Gaia, 4434 502, Portugal

  • Novartis Investigative Site

    RECRUITING

    Singapore, Singapore, S308433, Singapore

  • Novartis Investigative Site

    WITHDRAWN

    Port de Sagunt, Valencia, 46520, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Ciudad Real, 13005, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Seville, 41009, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Bursa, Nilufer, 16059, Turkey (Türkiye)

  • Novartis Investigative Site

    COMPLETED

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    COMPLETED

    Mersin, Yenisehir, 33110, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    WITHDRAWN

    Leicester, LE5 4PW, United Kingdom

  • Ochsner Health System

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Olive View UCLA Medical Center

    ACTIVE_NOT_RECRUITING

    Sylmar, California, 91342, United States

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • Royal Research Corp

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Stony Brook Internists PC

    RECRUITING

    East Setauket, New York, 11733, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Univ Calif Irvine

    WITHDRAWN

    Irvine, California, 92697, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Nebraska Medical Center

    ACTIVE_NOT_RECRUITING

    Omaha, Nebraska, 68198, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wichita Community Clcl Onco Program

    RECRUITING

    Wichita, Kansas, 67214, United States

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