Study of Mosunetuzumab Treatment in Patients with Systemic Lupus Erythematosus with or without Lupus Nephritis

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What is this study about?

This study focuses on Systemic Lupus Erythematosus (SLE), an autoimmune disease where the body’s immune system attacks its own tissues, with some patients also having Lupus Nephritis, which affects the kidneys. The study will test a medicine called mosunetuzumab, which is a specialized antibody given by subcutaneous injection (injection under the skin).

The purpose of this research is to evaluate how well mosunetuzumab works in helping patients achieve disease remission. The study will include two groups of patients: those who have SLE with kidney involvement (Lupus Nephritis) and those who have SLE without kidney problems. Both groups will receive treatment with mosunetuzumab, and their health will be monitored for changes in disease activity and overall well-being.

Throughout the study, doctors will track various aspects of the participants’ health, including changes in disease symptoms, kidney function, fatigue levels, and how well the medication is tolerated. They will also monitor the levels of certain proteins in the blood that indicate disease activity and check how the body processes the medication. The study will last several years to thoroughly evaluate the long-term effects of the treatment.

1 Initial treatment phase

You will receive mosunetuzumab through subcutaneous injection (under the skin)

The treatment will be administered in an open-label format, which means both you and the medical team will know what medication is being given

2 Monitoring period – Week 52

Your response to the treatment will be evaluated

Medical staff will check if you have achieved complete or partial remission of symptoms

Blood tests will be performed to measure antibody levels and complement proteins (C3 and C4)

You will complete questionnaires about your fatigue levels and assessment of disease activity

3 Primary evaluation – Week 76

The main assessment of treatment effectiveness will take place

Medical staff will evaluate if you have achieved remission

Additional blood tests will be conducted to check antibody levels

You will complete final questionnaires about fatigue and disease activity

4 Final assessment – Week 104

Final evaluation of complete or partial remission will be performed

Medical staff will conduct a complete safety assessment

Blood samples will be taken to measure drug levels in your body

The study will check for any immune response to the medication

5 Safety monitoring

Throughout the study, you will be monitored for side effects

Regular vital sign measurements and laboratory tests will be performed

Any unusual symptoms or reactions will be recorded and evaluated

Special attention will be paid to monitoring immune system responses

Who Can Join the Study?

  • Must have been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 6 months
  • Must agree to follow contraception requirements during the study
  • For patients with kidney involvement (Cohort 1):
    • Must have a kidney biopsy taken within 3 months before screening showing active lupus nephritis
    • Must have high levels of protein in urine (at least 1.5 g/g)
    • Must have low levels of C3 complement (a protein involved in immune system)
    • Must have active kidney disease despite at least 6 months of standard treatment
  • For patients without kidney involvement (Cohort 2):
    • Must have positive autoantibodies (proteins that attack healthy cells)
    • Must have low complement levels
    • Must have high disease activity despite current treatment
    • Must have received at least 6 months of advanced therapy without improvement
  • If previously treated with medications that reduce B-cells (like rituximab), last treatment must have been more than 6 months ago
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
  • Active or chronic infections, including:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
    • Tuberculosis (TB)
  • Presence of other autoimmune conditions besides SLE (Systemic Lupus Erythematosus)
  • Major surgery within 8 weeks before starting the study
  • Current pregnancy or breastfeeding
  • Significant heart problems or uncontrolled high blood pressure
  • Active cancer or history of cancer in the past 5 years (except for successfully treated skin cancer)
  • Severe kidney disease requiring dialysis
  • History of blood clotting disorders
  • Use of prohibited medications, including:
    • Live vaccines within 4 weeks before study
    • Other experimental drugs within 3 months before study
  • Mental health conditions that could interfere with study participation
  • Drug or alcohol abuse within the past 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Ospedale San Giovanni Bosco Turin Italy
Universita Degli Studi Di Brescia Brescia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
04.02.2026

Trial locations

Investigated drugs:

Mosunetuzumab is a medication designed to treat autoimmune conditions. It works by targeting specific immune cells in the body that are involved in the inflammatory response. This medication is being studied for its potential to help patients with systemic lupus erythematosus (SLE), a condition where the immune system attacks healthy tissues in the body, and lupus nephritis, which affects the kidneys. The medication is given through an infusion into the bloodstream and aims to reduce inflammation and help achieve disease remission in patients with these conditions.

Investigated diseases:

Systemic Lupus Erythematosus (SLE) – A chronic autoimmune disease where the body’s immune system mistakenly attacks its own tissues and organs. The condition can affect multiple body systems, including joints, skin, kidneys, blood cells, brain, heart, and lungs. SLE typically develops in episodes or flares, with periods of increased symptoms alternating with periods of mild or no symptoms. The disease commonly causes inflammation and can lead to various symptoms including joint pain, skin rashes (particularly a butterfly-shaped rash across the face), fatigue, and fever. When SLE affects the kidneys, the condition is known as lupus nephritis, which can cause inflammation and damage to the kidney tissues.

Trial ID:
2024-519930-22-00
Protocol code:
GA45799
Trial Phase:
Therapeutic exploratory (Phase II)

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