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Systemic lupus erythematosus – Trials in Disease

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Clinical Trials for Systemic Lupus Erythematosus: Current Research and Treatment Options

There are currently 44 ongoing clinical trials studying new treatments for systemic lupus erythematosus, an autoimmune disease where the body’s immune system attacks healthy tissues. These trials are investigating various medications including biological therapies, cell therapies, and targeted treatments, with research taking place across multiple European countries. The studies focus on evaluating both effectiveness and safety of new approaches for patients with moderate to severe forms of the disease who have not responded adequately to standard treatments.

Clinical trial locations

Study of Anifrolumab for Children and Teens with Moderate to Severe Lupus

This clinical trial evaluates the safety and effectiveness of anifrolumab in children and adolescents aged 5 to under 18 years with moderate to severe active SLE. The study involves administering anifrolumab through subcutaneous injection or intravenous infusion to determine appropriate dosing for younger patients.

Main inclusion criteria: Participants must have been diagnosed with SLE for at least 6 months, have a SLEDAI score of 4 or higher, test positive for specific autoantibodies, be on stable SLE treatments, weigh at least 15 kg, and use effective contraception methods if applicable. Boys must use condoms during the study period, and girls must have negative pregnancy tests and use birth control if sexually active.

Main exclusion criteria: Patients with other autoimmune conditions, active infections requiring treatment, pregnancy or breastfeeding, recent participation in other trials, allergies to study medication, significant organ problems, or active tuberculosis are excluded from participation.

Trial focus: The study monitors disease activity over time to evaluate how anifrolumab affects SLE symptoms and overall health in pediatric patients. Regular assessments track the medication’s effects on reducing disease activity and immune system markers.

Investigational drug: Anifrolumab is a medication that targets specific immune system pathways to reduce inflammation in SLE patients. The study evaluates its effectiveness in improving disease symptoms compared to placebo.

Study of CC-97540 CD19-targeted CAR T cells in patients with systemic lupus erythematosus who did not respond to previous immunosuppressive treatment

This trial investigates CC-97540, a cell therapy using modified T-cells, for patients with SLE and active refractory lupus nephritis who haven’t responded to standard treatments. The therapy involves collecting and modifying a patient’s own immune cells to better target disease-causing cells.

Main inclusion criteria: Participants must be at least 16 years old, weigh at least 40 kg, have SLE diagnosed according to EULAR/ACR 2019 criteria, have tried at least two different immune-suppressing medications for at least 3 months each without adequate improvement, and show active disease with specific BILAG scores and blood test results. For those with kidney involvement, a recent kidney biopsy is required.

Main exclusion criteria: Patients with severe active lupus nephritis requiring high-dose steroids, history of severe allergic reactions, active serious infections (including tuberculosis, hepatitis B/C, or HIV), significant uncontrolled heart/liver/lung conditions, recent cancer diagnosis or treatment, pregnancy or breastfeeding, recent live vaccinations, concurrent trial participation, use of prohibited medications, mental health conditions affecting participation, or substance abuse are excluded.

Trial focus: The study compares CC-97540 effectiveness against standard treatments over approximately one year, monitoring participants for symptom improvements and side effects, particularly cytokine release syndrome and neurotoxicity in the first few weeks after treatment.

Investigational drug: CC-97540 (BMS-986353) is a CAR T-cell therapy where patient’s T cells are modified to target CD19-expressing B-cells. It requires preliminary lymphodepletion using cyclophosphamide and fludarabine phosphate before the single infusion treatment.

Study of Obexelimab Treatment for Adults with Systemic Lupus Erythematosus (SLE)

This clinical trial evaluates obexelimab’s effectiveness in reducing disease activity in adults with moderate to severe SLE over 24 weeks. Participants receive either obexelimab or placebo through subcutaneous injection alongside their standard lupus treatments.

Main inclusion criteria: Participants must be 18-70 years old with SLE diagnosed for at least 24 weeks, have positive blood tests (ANA 1:80+, anti-dsDNA+, or anti-Sm+), show active disease with specific scores, be on stable treatments (antimalarials with/without corticosteroids/immunosuppressants for at least 8 weeks), and use effective contraception methods if applicable.

Main exclusion criteria: Patients with severe allergic reactions to biologics, active/chronic infections, severe kidney disease requiring dialysis, severe liver disease, cancer history within 5 years, pregnancy/breastfeeding, recent investigational drug use, planned major surgery, unstable heart conditions, uncontrolled high blood pressure, blood clotting disorders, substance abuse, mental health conditions interfering with participation, or inability to follow procedures are excluded.

Trial focus: The study monitors disease activity, skin symptoms, joint problems, and fatigue levels throughout the 24-week period to determine treatment effectiveness and safety.

Investigational drug: Obexelimab is an investigational monoclonal antibody targeting specific immune system proteins to reduce inflammation and disease activity in SLE patients, administered through intravenous infusion with a maximum dose of 250 mg daily.

Study on Frexalimab for Treating Active Systemic Lupus Erythematosus in Patients

This trial evaluates frexalimab’s effectiveness in reducing disease activity over 24 weeks in patients with active SLE. Participants receive either frexalimab or placebo alongside usual care, administered through injection (intravenous or subcutaneous).

Main inclusion criteria: Participants must have SLE for at least 6 months with positive ANA test (1:80+), positive for at least one serological characteristic, have hSELENA-SLEDAI score 6+ with specific points from arthritis/rash and clinical score 4+, have at least 1 BILAG A or 2 BILAG B scores, be on stable standard treatments, weigh 45-120 kg, and use contraception if required by local regulations.

Main exclusion criteria: Patients with severe allergic reactions to medications, pregnancy/breastfeeding, other serious health conditions, recent clinical trial participation (within 30 days), drug/alcohol abuse history (past year), inability to comply with procedures, active infections requiring treatment, recent use of interfering medications, cancer history (within 5 years except certain skin cancers), and certain other autoimmune diseases are excluded.

Trial focus: The study assesses lupus symptom improvements, including joint pain and skin rashes, over the 52-week period, monitoring disease activity changes and corticosteroid use alongside safety evaluations.

Investigational drug: Frexalimab (SAR441344) is administered via injection to evaluate its ability to reduce SLE disease activity by modulating immune system responses.

Study on Ianalumab for Patients with Systemic Lupus Erythematosus

This Phase 3 trial evaluates ianalumab’s effectiveness, safety, and tolerability in SLE patients over 60 weeks when used alongside standard treatments. Participants receive monthly subcutaneous injections of 300 mg ianalumab or placebo.

Main inclusion criteria: Participants must be at least 12 years old (18+ in some countries), have SLE diagnosis meeting specific criteria for 6+ months, show elevated antinuclear antibodies with specific patterns, be on stable treatment with corticosteroids/antimalarials/DMARDs, have SLEDAI-2K score 6+ (excluding certain symptoms), demonstrate disease activity in at least one or two organ systems, and weigh at least 35 kg.

Main exclusion criteria: Patients with other serious health conditions, pregnancy/breastfeeding, recent infections requiring treatment, recent receipt of certain medications affecting results, drug/alcohol abuse history, other clinical trial participation, known medication allergies, recent surgery, cancer history (except certain skin cancers), specific heart/liver/kidney/lung/neurological/psychiatric/gastrointestinal/blood/metabolic disorders, or various other health conditions are excluded.

Trial focus: The primary goal is achieving SRI-4 response at Week 60, with secondary assessments including maintaining reduced corticosteroid doses and achieving low disease activity states.

Investigational drug: Ianalumab is a monoclonal antibody administered subcutaneously targeting specific immune cells to reduce inflammation and disease activity in SLE patients.

Study on Long-Term Safety of Cenerimod for Adults with Moderate-to-Severe Systemic Lupus Erythematosus

This study monitors the long-term safety and tolerability of cenerimod over up to 36 months in adults with moderate-to-severe SLE who completed a previous 12-month treatment period. Participants continue receiving 4 mg daily cenerimod alongside their existing SLE background therapy.

Main inclusion criteria: Participants must have completed the previous 12-month study without meeting discontinuation criteria, attended the last scheduled visit (with possible exceptions for circumstances beyond control), signed informed consent, and if female of childbearing potential, have negative pregnancy test and agree to monthly pregnancy tests and effective contraception for study duration plus 6 months after treatment ends.

Main exclusion criteria: Patients with conditions other than SLE, outside specified age range, inability to follow procedures or take medication as required, interfering medical conditions, pregnancy/breastfeeding, current clinical trial participation, recent drug/alcohol abuse, recent infection/illness, known medication allergies, or recent receipt of interfering medications/treatments are excluded.

Trial focus: The study continuously monitors participants for treatment-emergent adverse events, serious adverse events, and specific adverse events related to treatment or SLE comorbidities, with monthly pregnancy tests for women of childbearing potential throughout and for 6 months post-treatment.

Investigational drug: Cenerimod is an oral medication (film-coated tablet, 4 mg) used alongside existing SLE treatments to assess long-term safety and tolerability in moderate-to-severe SLE patients.

Study on Long-Term Safety of Ianalumab for Patients with Systemic Lupus Erythematosus

This study evaluates the long-term safety and tolerability of ianalumab in SLE patients over several years. Participants receive 300 mg ianalumab through monthly or quarterly subcutaneous injections.

Main inclusion criteria: Participants must sign informed consent (with parent/guardian if under 18, signing themselves once reaching consent age), have completed one of the two SIRIUS-SLE core studies through Week 60 without discontinuation, and have investigator determination that continued treatment would be beneficial. Both males and females are eligible.

Main exclusion criteria: Specific exclusion criteria are not detailed in the source data beyond standard trial restrictions.

Trial focus: The study monitors treatment-emergent and serious adverse events, assesses SRI-4 response proportion and SLICC/ACR damage index changes up to Week 216, evaluates average daily oral corticosteroid dose and moderate/severe disease flare rates annually up to Week 216.

Investigational drug: Ianalumab is a monoclonal antibody administered subcutaneously (monthly or quarterly) targeting specific immune cells to reduce inflammation and disease activity in active SLE patients.

Study on Steroid Withdrawal in Systemic Lupus Erythematosus Patients Using Prednisone

This 36-month trial examines whether safely stopping glucocorticoid (prednisone) treatment is as effective as continuing low-dose treatment in SLE patients with stable disease on standard therapy. Participants are randomly assigned to either withdraw from or continue their low-dose glucocorticoid treatment.

Main inclusion criteria: Participants must be 18-75 years old with SLE diagnosis (2019 criteria), have stable immunosuppressive drug treatment for 4+ months, be in modified LLDAS for 6+ months (SLEDAI-2K score ≤4 without major organ activity, physician assessment ≤1, stable immunosuppressant doses, stable prednisone ≤5 mg/day for 6+ months), be on stable antimalarial treatment for 6+ months (unless contraindicated), show hydroxychloroquine adherence (blood levels ≥500 ng/mL), and sign informed consent.

Main exclusion criteria: Patients without SLE, not in LLDAS, not on standard-of-care therapy, outside 18-65 age range, non-binary gender identification, or considered vulnerable populations are excluded.

Trial focus: The primary goal is maintaining low disease activity throughout 36 months, with assessments at 12, 24, and 36 months evaluating LLDAS maintenance proportion and long-term glucocorticoid withdrawal effects versus maintenance.

Investigational drug: Glucocorticoids are tested to determine if stopping them is as effective as continuing low doses in stable SLE patients on standard treatment.

Study on the Effectiveness and Safety of Dapirolizumab Pegol for Patients with Moderate to Severe Systemic Lupus Erythematosus

This 52-week trial evaluates whether adding dapirolizumab pegol to standard SLE treatments provides long-term improvement in moderately to severely active disease. Participants receive either dapirolizumab pegol or placebo through intravenous infusion alongside their existing medications (antimalarials, corticosteroids, immunosuppressants).

Main inclusion criteria: Participants must be 16+ years old with moderate-to-severe disease activity from ongoing active SLE or sudden worsening despite stable standard treatment, have SLE diagnosis 24+ weeks before screening (meeting 2019 EULAR/ACR criteria), show serological evidence (anti-dsDNA antibodies, low complement C3/C4, or ANA with specific SLE-related antibodies), have active disease with specific BILAG 2004 and SLEDAI-2K scores, and be on stable standard treatments (antimalarials with/without corticosteroids/immunosuppressants, or corticosteroids/immunosuppressants only if antimalarials unsuitable).

Main exclusion criteria: Patients with severe allergic reactions to similar medications, other serious health conditions, pregnancy/breastfeeding, current clinical trial participation, recent interfering treatments, substance abuse, inability to follow procedures/attend visits, certain infections, recent surgery, unstable heart conditions, uncontrolled high blood pressure, or blood clotting disorders are excluded.

Trial focus: The study monitors disease activity reduction, symptom improvements, adverse events, and medication tolerance over 52 weeks with regular assessments at various intervals.

Investigational drug: Dapirolizumab Pegol (DZP) is administered intravenously to evaluate significant and lasting improvement in moderately to severely active SLE symptoms when added to standard treatments.

Study on the Effectiveness and Safety of Deucravacitinib for Patients with Active Systemic Lupus Erythematosus (SLE)

This 52-week trial evaluates deucravacitinib effectiveness compared to placebo in treating adults with active SLE. Participants receive either 3 mg deucravacitinib tablets or placebo orally once daily alongside their usual lupus medications.

Main inclusion criteria: Participants must be 18-75 years old with SLE diagnosis 24+ weeks before screening (meeting 2019 EULAR/ACR criteria), test positive for lupus-related autoantibodies (ANA 1:80+, anti-dsDNA, or anti-Sm), have active lupus (total SLEDAI-2K ≥6, clinical SLEDAI-2K ≥4 including joint involvement, cutaneous vasculitis, and/or rash), and be on stable background therapy with anti-malarials and/or immunosuppressants, potentially including corticosteroids.

Main exclusion criteria: Having active SLE is the only specified exclusion criterion in the source data.

Trial focus: The study monitors symptom improvements (particularly joint and skin conditions), disease activity changes, and overall health over 52 weeks with regular check-ups tracking progress and side effects.

Investigational drug: Deucravacitinib is a selective TYK2 inhibitor (3 mg oral tablet) targeting specific immune system pathways to reduce inflammation and help control SLE symptoms.

Summary

The 44 ongoing clinical trials for systemic lupus erythematosus represent a significant research effort across Europe, with notable concentration in countries like Germany, Spain, Poland, France, and Italy. The trials span multiple approaches including biological therapies (monoclonal antibodies like anifrolumab, belimumab, obinutuzumab), innovative cell therapies (CAR T-cell treatments), targeted small molecules (deucravacitinib, cenerimod), and combination approaches.

Many studies focus on moderate to severe disease, particularly in patients who haven’t responded adequately to standard treatments. There’s notable interest in pediatric populations, with several trials including children and adolescents aged 5-17 years. Research also addresses specific manifestations like lupus nephritis and cutaneous involvement.

The geographic distribution shows strong participation from Central and Southern European countries, with some trials limited to single countries while others span 10+ nations. Most trials evaluate both effectiveness and long-term safety, with study durations ranging from 24 weeks to several years, reflecting the chronic nature of the disease and need for sustained treatment evaluation.

Ongoing Clinical Trials on Systemic lupus erythematosus

  • Study of Enpatoran in Adults with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE)

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Greece Poland Romania Spain

  • Study on Ianalumab for Patients with Systemic Lupus Erythematosus

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Romania

  • Study on Belimumab for Children with Systemic Lupus Erythematosus (SLE)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Afimetoran for Patients with Active Lupus

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France Germany Ireland Poland Romania Spain

  • Study of PF-06823859 for Adults with Active Cutaneous or Systemic Lupus Erythematosus with Skin Symptoms

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Greece Spain

  • Study of GLPG3667 for Adults with Active Systemic Lupus Erythematosus

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Hungary Poland Spain

  • Study on Frexalimab for Treating Active Systemic Lupus Erythematosus in Patients

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Italy Spain

  • Study on the Effects of Cenerimod for Adults with Moderate to Severe Systemic Lupus Erythematosus

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Greece Poland Romania

  • Study on the Effectiveness and Safety of Cenerimod for Adults with Moderate to Severe Systemic Lupus Erythematosus

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Poland Portugal Spain

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