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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

12 criteria

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 trial?

16 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified
Rome, Italy
IRCCS Humanitas Research Hospital
Verified
Rozzano, Italy
Universita Degli Studi Di Brescia
Verified
Brescia, Italy

Trial locations

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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.

Mosunetuzumab

What is already known about the treatment

Mosunetuzumab - A novel biologic medication administered through intravenous infusion, specifically designed for treating Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN). This investigational drug works by targeting and modulating B-cells in the immune system, helping to reduce the autoimmune response that causes inflammation and organ damage in lupus patients. Currently undergoing Phase II clinical trials, mosunetuzumab belongs to the class of monoclonal antibodies and represents a promising therapeutic approach for patients who haven't responded adequately to conventional lupus treatments.

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.