Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

This study, named 'A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus', is focused on finding out if a new medicine, Obinutuzumab, can help people with lupus, also known as Systemic Lupus Erythematosus (SLE). Researchers want to see how well it works and if it's safe compared to a dummy treatment (placebo). All participants in this study will continue to receive their usual lupus treatments. The study is particularly looking for people with active lupus that is causing symptoms and who test positive for certain antibodies often found in lupus. By comparing the new medication to a placebo, doctors can learn if Obinutuzumab could be a good new option for treating lupus.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

303

Start

26 Oct 2021

Estimated completion

13 Mar 2028

Systemic Lupus Erythematosus

What is this study about?

This research study is looking into a new medication called Obinutuzumab for people who have Systemic Lupus Erythematosus, often shortened to SLE or simply lupus. Lupus is a long-term condition that affects many parts of the body, causing inflammation and a variety of symptoms.

The main goal of this study is to find out if Obinutuzumab is a safe and effective treatment for lupus. To do this, some people taking part will receive Obinutuzumab, while others will receive a 'placebo', which looks exactly like the study drug but contains no active medicine. This is a common way to test new treatments fairly, as neither the patients nor their doctors will know who is getting which treatment until the study is over. Everyone in the study will also continue to receive their standard lupus treatments alongside the study medication.

By comparing the health improvements and any side effects in the group receiving Obinutuzumab with those receiving the placebo, the researchers hope to understand if Obinutuzumab could become a useful new treatment option for people living with active lupus. This kind of research is very important for developing new ways to manage conditions like lupus and improve patients' quality of life.

Key takeaways

This study is testing a new drug, Obinutuzumab, for active lupus.
It compares the new drug to a dummy treatment (placebo).
All participants will continue their usual lupus treatments.
The study aims to check if Obinutuzumab is safe and effective.
You must have active lupus and be on existing lupus medication to qualify.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 75 years old diagnosed with Systemic Lupus Erythematosus (lupus) for at least 12 weeks. Your lupus also needs to be active, meaning it's currently causing noticeable symptoms that your doctor can measure. You would also need to be already taking at least one of the standard medicines for lupus, such as steroids, antimalarials, or other immunosuppressants, at a stable dose.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you wouldn't be able to participate. Also, if your lupus has severely affected your kidneys, or if you have a serious ongoing infection, this study might not be suitable. Certain other treatments you might have received recently could also prevent you from joining. The study team will check these details carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with lupus at least 3 months ago?
Is your lupus currently active and causing symptoms?
Are you currently taking standard lupus medications (like steroids, antimalarials, or immunosuppressants)?
Are you pregnant or breastfeeding (if so, you cannot join)?
Do you have severe kidney problems related to your lupus or a serious infection (if so, you might not be able to join)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic so the study team can monitor your health and how you respond to the treatment. You would receive either the new study medication, Obinutuzumab, or a placebo (dummy treatment) through an infusion, which means it would be given through a drip into your arm. You might also receive other common medications like paracetamol or specific anti-allergy medicines before your infusions to help prevent any reactions.

Throughout the study, you would have various assessments, including blood tests, physical examinations, and questionnaires to track your lupus symptoms and overall well-being. The total duration of your participation would involve the treatment period and a follow-up period to ensure your safety and track long-term effects. The study doctors and nurses will explain the full schedule and how often you'd need to attend.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring of your condition. However, there are also potential risks, including side effects from Obinutuzumab or other study medications, or the possibility that the treatment may not work for you. You might also receive the placebo, which means you wouldn't be getting the active study drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (64)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Pinnacle Research Group
Verified postcode
Anniston, United States
Unity Health - White County Medical Center- Rheumatology
Verified postcode
Searcy, United States
Providence Medical Foundation
Verified postcode
Fullerton, United States
Arthritis & Rheumatism
Verified postcode
Aventura, United States
Great Lakes Center of Rheumatology
Verified postcode
Lansing, United States
Clinical Research Institute of Michigan, LLC
Verified postcode
Troy, United States
Northwell Health Division of Rheumatology
Verified postcode
Great Neck, United States
Columbia University Medical Center
Verified postcode
New York, United States
Joint & Muscle Research Institute
Verified postcode
Charlotte, United States
The Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States
Paramount Medical Research & Consulting, LLC
Verified postcode
Middleburg Heights, United States
Precision Comprehensive Clinical Research Solutions
Verified postcode
Colleyville, United States

Common questions

What is Systemic Lupus Erythematosus (SLE) or lupus?

Lupus is a long-term autoimmune disease where your body's immune system mistakenly attacks healthy tissues, leading to widespread inflammation and damage to organs.

What is Obinutuzumab?

Obinutuzumab is a medicine being tested to see if it can help reduce the activity of lupus and improve symptoms.

What does 'placebo' mean?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the real treatment fairly.

Why can't I be pregnant or breastfeeding?

For safety reasons, pregnant or breastfeeding individuals are not included in most new drug studies, as the effects on a baby are unknown.

Will I still take my regular lupus medicine?

Yes, everyone in the study will continue to receive their standard lupus treatments alongside the study medication.