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New shot could tame lupus kidney flares

NCT ID NCT05126277

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding ianalumab (a biologic injection) to standard therapy helps control active lupus nephritis, a serious kidney complication of lupus. About 452 adults with active lupus nephritis are receiving either ianalumab every 4 or 12 weeks or a placebo, alongside their usual care. The main goal is to see if more people achieve a stable complete kidney response by 72 weeks.

What this could mean

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

Active substance
ianalumab (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could provide a new treatment option for people with lupus nephritis, helping to control kidney inflammation and reduce the need for strong immune-suppressing drugs.
What could go wrong
This is still a clinical trial, so it is not yet proven to work. Even if successful, the drug may only help some patients and could have side effects like infections or allergic reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

452 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Feb 2031

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: Participants eligible for inclusion in this study must meet all of the following criteria: * Adult male and female participants aged 18 years or older at the time of screening * Weigh at least 35 kg at screening * Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria * Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result * Active LN at screening, as defined by meeting the 3 following criteria: * Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria. * UPCR ≥ 1.0 g/g on 24h urine collection at Screening * eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli * Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA * Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization * Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications * Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization * Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne. * Able to communicate well with the Investigator to understand and comply with the requirements of the study Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study: * Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation * Sclerosis in \> 50% of glomeruli on renal biopsy * Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of certain Traditional Chinese Medicines * Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered \< 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy * Prior treatment with any of the following within 12 weeks prior to randomization * Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis * Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors) * Thalidomide treatment and/or methotrexate * Combination of DMARDs * Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA * Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization * History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation * Any one of the following laboratory values at screening: * Hemoglobin levels \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia * Platelet count \< 25 x 1000/µL * Absolute neutrophil count (ANC) \< 0.8 x 1000/µL * Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation. * History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients * Receipt of live/attenuated vaccine within a 4-week period prior to randomization * History of primary or secondary immunodeficiency, including a positive HIV test result * History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases * Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study * Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant * Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines) * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication * Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment Other protocol -defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

lupus nephritis nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis

Contacts and locations

Locations

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70601, United States

  • Advanced Medical Research

    La Palma, California, 90623, United States

  • Circuit Clinical

    Orchard Park, New York, 14127, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30303, United States

  • Fides Clinical Research

    Atlanta, Georgia, 30342, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Kaiser Permanente

    San Diego, California, 92111, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • NY Nephrology

    Clifton Park, New York, 12065, United States

  • Northwell Health

    New York, New York, 10028, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABI, Argentina

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT, Argentina

  • Novartis Investigative Site

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    CABA, C1426ABP, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    Vitória, Espírito Santo, 29055-450, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Novartis Investigative Site

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Novartis Investigative Site

    Santo André, São Paulo, 09090-790, Brazil

  • Novartis Investigative Site

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7, Canada

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Novartis Investigative Site

    Etobicoke, Ontario, M9W 6V1, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Novartis Investigative Site

    Santiago, RM, 7500922, Chile

  • Novartis Investigative Site

    Temuco, 4781151, Chile

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510120, China

  • Novartis Investigative Site

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518037, China

  • Novartis Investigative Site

    Liuzhou, Guangxi, 545005, China

  • Novartis Investigative Site

    Haikou, Hainan, 570311, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430060, China

  • Novartis Investigative Site

    Changsha, Hunan, 410008, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Changchun, Jilin, 130041, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110004, China

  • Novartis Investigative Site

    Binzhou, Shandong, 256603, China

  • Novartis Investigative Site

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    Xian, Shanxi, 710004, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Chongqing, 400038, China

  • Novartis Investigative Site

    Guangzhou, 510080, China

  • Novartis Investigative Site

    Guangzhou, 510280, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Shanghai, 200080, China

  • Novartis Investigative Site

    Shanghai, 200127, China

  • Novartis Investigative Site

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110111, Colombia

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Tallinn, 10117, Estonia

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Lyon, 69003, France

  • Novartis Investigative Site

    Marseille, 13005, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01011, Guatemala

  • Novartis Investigative Site

    Quetzaltenango, Departamento de Quetzaltenango, 09001, Guatemala

  • Novartis Investigative Site

    Guatemala City, 01010, Guatemala

  • Novartis Investigative Site

    Kwun Tong, Kowloon, 999077, Hong Kong

  • Novartis Investigative Site

    Tuenmen, 999077, Hong Kong

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1097, Hungary

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 079, India

  • Novartis Investigative Site

    Secunderabad, Telangana, 500003, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    Chandigarh, 160012, India

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Udine, UD, 33100, Italy

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161, Lithuania

  • Novartis Investigative Site

    Vilnius, LT-08406, Lithuania

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Sibu, Sarawak, 96000, Malaysia

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400, Malaysia

  • Novartis Investigative Site

    León, Guanajuato, 37160, Mexico

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64440, Mexico

  • Novartis Investigative Site

    Oaxaca City, 68020, Mexico

  • Novartis Investigative Site

    Querétaro, 76070, Mexico

  • Novartis Investigative Site

    Oradea, Jud Bihor, 410619, Romania

  • Novartis Investigative Site

    Timișoara, Timiș County, 300723, Romania

  • Novartis Investigative Site

    Bucharest, 022328, Romania

  • Novartis Investigative Site

    Singapore, Singapore, 308433, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620, South Korea

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Seoul, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36214, Spain

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46017, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28027, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ, United Kingdom

  • Novartis Investigative Site

    London, SE1 9RT, United Kingdom

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 700000, Vietnam

  • Parris and Associates Rheumatology

    Lawrenceville, Georgia, 30044, United States

  • Precision Comprehensive Research

    Colleyville, Texas, 76034, United States

  • School Of Medicine

    Sacromento, California, 95817, United States

  • UMC New Orleans

    New Orleans, Louisiana, 70112, United States

  • Uni Wisconsin School Med Pub Health

    Madison, Wisconsin, 53792, United States

  • Uni of Texas Health Science Center

    San Antonio, Texas, 78229, United States

  • Univ of Nevada School of Med

    Las Vegas, Nevada, 89102, United States

  • Univ of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • University Of Alabama

    Birmingham, Alabama, 35294, United States

  • University Of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University Of Miami

    Miami, Florida, 33136, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of California San Diego

    San Deigo, California, 92037, United States

  • Univof Texas Southwestern Med Cntr

    Dallas, Texas, 75235, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

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