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New hope for lupus patients: two experimental drugs show promise in reducing disease activity

NCT ID NCT03656562

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested two experimental drugs, VAY736 and CFZ533, in 107 adults with systemic lupus erythematosus (SLE). The goal was to see if these drugs could reduce lupus symptoms and allow patients to lower their steroid use. Participants received either one of the drugs or a placebo, and researchers measured disease activity and safety over several months.

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

107 people

The number who actually took part.

Started

Dec 2018

Finished

Apr 2025

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 75 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: * Written informed consent must be obtained before any assessment is performed * Fulfill ≥4 of the 11 American College of Rheumatology 1997 classification criteria for SLE * Patient diagnosed with SLE for at least 6 months prior to screening * Elevated serum titers at screening of ANA (≥1:80) of a pattern consistent with an SLE diagnosis, including at a minimum either anti-double stranded DNA (anti-ds DNA) or anti-Ro (SSA) or anti-La (SSB) or anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm) * Currently receiving corticosteroids and/or anti-malarial and/or thalidomide treatment and/or another DMARD on a stable dose according to protocol requirements * SLEDAI-2K score of ≥6 at screening * BILAG 2004 score of one "A" score either in the mucocutaneous or in the musculoskeletal domain or one "B" score in either the mucocutaneous or musculoskeletal domain and at least one "A" or "B" score in a second domain at screening * Weigh at least 40 kg at screening Exclusion Criteria: Cohort 2 (CFZ533/Placebo) only: * Patients who are at significant risk for thromboembolic events based on the following: * History of either thrombosis or 3 or more spontaneous abortions * Presence of lupus anticoagulant or significantly prolonged activated partial thromboplastin time (aPTT) consistent with co-existent anti-phospholipid syndrome and without concurrent prophylactic treatment with aspirin or anticoagulants as per local standard of care All Cohorts: * History of receiving prior to screening: * Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or other oral DMARD * Within 24 weeks: cyclophosphamide or biologics such as intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab) * Any B-cell depleting therapies (e.g., anti-CD20 mAb, anti-CD22 mAb, anti-CD52 mAb) or TACI-Ig (atacicept) administered within 52 weeks prior to screening, and a B-cell count \<50 cells/μ at the time of screening * Evidence of past exposure to tuberculosis as assessed by Quantiferon testing at screening * Presence of human immunodeficiency virus (HIV) infection at screening * Severe organ dysfunction or life threatening disease; ECOG performance status \> 1 at screening * Presence of WHO Class III-IV renal involvement with proliferative disease Presence of severe lupus kidney disease as defined by proteinuria above 6 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.5 mg/dL (221.05 μmol/L), or requiring immune suppressive induction or maintenance treatment exceeding protocol defined limits * Active viral, bacterial or other infections at the time of screening or enrollment * Receipt of live/attenuated vaccine within a 2-month period before first dosing * Uncontrolled, co-existing serious disease, e.g., uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to first dosing, or significant, unresolved illness within 2 weeks prior to first dosing * History of hypersensitivity to drugs of similar chemical class * Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Subjects who are HBsAg negative and HBcAb positive are excluded unless negative for HBV DNA. Once past screening and enrolled into study, requirements for monitoring and antiviral treatment are enacted. Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus (SLE)

Contacts and locations

Locations

  • Novartis Investigative Site

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Shanghai, 200127, China

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Pessac, 33604, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Berlin, 10117, Germany

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1023, Hungary

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4600001, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162-8655, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    Poznan, 60-218, Poland

  • Novartis Investigative Site

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    Moscow, 115522, Russia

  • Novartis Investigative Site

    Saint Petersburg, 194044, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620144, Russia

  • Novartis Investigative Site

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Taichung, Taiwan ROC, 40201, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

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