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Can lupus kidney patients stop treatment? new study tests ianalumab withdrawal

NCT ID NCT06711887

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This 2-year extension study looks at lupus nephritis patients who finished a previous trial of ianalumab. Some patients who responded well will stop treatment to see if their kidney disease stays under control. Others who did not respond or were already on open-label ianalumab will continue the drug. The study will track safety, kidney flares, and the need for other medications.

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 monoclonal antibody that targets B cells)
What this could lead to
If successful, this study could show that some lupus nephritis patients can safely stop treatment without their kidney disease flaring up, and that ianalumab is safe and effective for long-term use.
What could go wrong
This is an extension study, so it builds on earlier results. However, it is still testing safety and how well the drug works over time. There is no guarantee that stopping treatment will be safe for everyone, and side effects are possible.

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

About 348 people

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

Started

May 2025

Expected to finish

Aug 2035

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: 1. Signed informed consent prior to participation in the extension study. 2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment. Exclusion Criteria: 1. Use of prohibited therapies 2. Pregnant or nursing (lactating) women.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

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

    47 sites in 18 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

  • Circuit Clinical

    RECRUITING

    Orchard Park, New York, 14127, United States

  • Novartis Investigative Site

    RECRUITING

    Vitória, Espírito Santo, 29055-450, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    RECRUITING

    Santo André, São Paulo, 09090-790, Brazil

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    RECRUITING

    Shenzhen, Guangdong, 518037, China

  • Novartis Investigative Site

    RECRUITING

    Liuzhou, Guangxi, 545005, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130041, China

  • Novartis Investigative Site

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Novartis Investigative Site

    RECRUITING

    Binzhou, Shandong, 256603, China

  • Novartis Investigative Site

    RECRUITING

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Chongqing, 400038, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510080, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510280, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200080, China

  • Novartis Investigative Site

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Grenoble, 38043, France

  • Novartis Investigative Site

    RECRUITING

    Guatemala City, Departamento de Guatemala, 01011, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Quetzaltenango, Departamento de Quetzaltenango, 09001, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Guatemala City, 01010, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Tuenmen, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1097, Hungary

  • Novartis Investigative Site

    RECRUITING

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Sibu, Sarawak, 96000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    León, Guanajuato, 37160, Mexico

  • Novartis Investigative Site

    RECRUITING

    Oaxaca City, 68020, Mexico

  • Novartis Investigative Site

    RECRUITING

    Querétaro, 76070, Mexico

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 022328, Romania

  • Novartis Investigative Site

    RECRUITING

    Singapore, Singapore, 308433, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    RECRUITING

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    RECRUITING

    Ho Chi Minh City, VNM, 700000, Vietnam

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