RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

This study is testing a new medicine, obinutuzumab, for young people aged 5 to 17 who have a kidney problem called lupus nephritis. This is a condition where the body's immune system mistakenly attacks the kidneys, causing inflammation. We want to find out if obinutuzumab is safe, how effective it is in treating the condition, and how it moves through the body. The study includes teenagers (12-17 years old) and a younger group of children (5-11 years old). For teenagers, it's a 'randomised, double-blind, placebo-controlled' study, meaning some will get the new medicine, and others a dummy medicine, without knowing which. For the younger children, we'll focus on safety and how their bodies handle the medicine.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

Start

12 May 2022

Estimated completion

14 Jun 2030

Lupus Nephritis

What is this study about?

Imagine your body's immune system as a team of defenders that protects you from germs. In lupus, this team sometimes gets confused and starts attacking healthy parts of your own body, like your kidneys. When this happens to the kidneys, it's called lupus nephritis. This can cause problems like swelling and changes in how well your kidneys work.

Doctors are always looking for better ways to help young people with lupus nephritis. This study is testing a new medicine called obinutuzumab. It's hoped that this medicine might help calm down the overactive immune system in the kidneys. The study is split into two main parts: one for teenagers aged 12 to less than 18, and another for younger children aged 5 to less than 12.

For the teenagers, we'll compare obinutuzumab to a 'placebo' (a dummy medicine that looks the same but has no active drug). This helps us see if the new medicine is truly making a difference. For the younger children, the main goal is to carefully check the safety of obinutuzumab and understand how their bodies process the medicine. Understanding these things can help doctors decide if it's a good option for future treatment.

Key takeaways

This study is for young people aged 5 to 17 with a kidney condition called lupus nephritis.
It's testing a new medicine, obinutuzumab, to see if it's safe and effective.
Teenagers (12-17) may receive the study medicine or a placebo (dummy medicine).
Younger children (5-11) will receive the study medicine, focusing on safety.
Participants will have regular medical check-ups, blood, and urine tests.
You can choose to stop participating at any time.

Who may be eligible?

This study is looking for young people with a kidney condition called lupus nephritis. To be part of the study, you need to be between 5 and 17 years old. You must have had a kidney biopsy (a small sample taken from your kidney) in the past year that showed a specific type of active lupus nephritis (called Class III or IV).

Your doctors will also need to confirm that you have Systemic Lupus Erythematosus (SLE), which is the broader condition that causes lupus nephritis. You also need to have certain levels of protein in your urine, which is a sign of kidney inflammation. Additionally, you should have received a specific type of treatment for active lupus nephritis within the last 12 months.

Some things might mean you can't join the study. For example, if you have very severe lupus affecting your brain, or if more than half of your kidney tissue is scarred. Also, if you have a current serious infection, or if you have certain other serious health problems, you might not be able to take part. The study also cannot include those with only one specific, less common type of lupus nephritis (isolated Class V).

Quick self-check

Are you between 5 and 17 years old?
Have you been diagnosed with lupus?
Did you have a kidney biopsy in the last year that showed active lupus nephritis (Class III or IV)?
Do you have a certain amount of protein in your urine?
Have you received a specific treatment for active lupus nephritis recently?
Do you have any severe lupus affecting your brain or a serious infection right now?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, you would have medical check-ups, blood tests, and urine tests to monitor your kidney health and how your body is reacting to the medicine. You might also have physical examinations.

If you are a teenager (12-17), you would be randomly assigned to receive either the study medicine (Obinutuzumab) or a placebo (a dummy medicine without active drug), along with other common lupus medications. Neither you nor your doctor would know which one you are getting. If you are a younger child (5-11), you would receive the study medicine, and doctors would carefully watch for any side effects and how your body handles the medicine.

Throughout the study, you would also continue to take other prescribed lupus medications, like mycophenolate mofetil. Before starting, and at certain points during the study, you might receive other medications like acetaminophen (paracetamol), diphenhydramine, or methylprednisolone to help manage any reactions. Your doctor will monitor your progress and overall health. The full duration of participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in a study like this might offer a chance to try a new medicine that could potentially help your lupus nephritis, and you would receive very close medical monitoring. However, there are also potential risks; the study medicine might cause side effects, or it might not work as hoped. Your doctors will explain all known side effects and monitor you carefully for any new ones. It’s important to remember that joining a clinical study is always voluntary, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (42)

Loma Linda University health
Loma Linda, United States· Recruiting
UCSF Benioff Childrens Hospital
San Francisco, United States· Recruiting
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, United States· Recruiting
Emory Children's Center
Atlanta, United States· Recruiting
Indiana University Health University Hospital
Indianapolis, United States· Recruiting
Louisiana State University
Shreveport, United States· Recruiting
Hackensack University Medical Center
Hackensack, United States· Withdrawn
Cohen Children's Medical Center of New York
Queens, United States· Recruiting
Cincinnati Childrens Hospital
Cincinnati, United States· Recruiting
Chldren?s Hospital of Philadelphia
Philadelphia, United States· Withdrawn
Texas Arthritis Center
El Paso, United States· Withdrawn
Ser Servicos Especializados Em Reumatologia
Salvador, Brazil· Recruiting

+30 more sites — see the official record for the full list.

Common questions

What is lupus nephritis?

It's a kidney problem that can happen when your immune system, which usually fights off germs, mistakenly attacks your kidneys, causing inflammation.

What is obinutuzumab?

It's a new medicine being tested to see if it can help treat lupus nephritis by affecting your immune system.

Will I get the actual medicine or a dummy one?

If you are aged 12-17, you might get the study medicine or a dummy medicine (placebo). Neither you nor your doctor will know which one. If you are 5-11, you will get the study medicine.

How long will I be in the study?

The study team will explain the full time commitment, including regular visits and follow-up, at the start of the study.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, and it won't affect the medical care you receive for your condition.

How to find out more

Reference Study ID Number: WA42985 https://forpatients.roche.com/

global.rochegenentechtrials@roche.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.