RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

This research study is looking into a new medication called dapirolizumab pegol (DZP) for individuals living with systemic lupus erythematosus, commonly known as lupus. Specifically, it's for those with moderate to severe forms of the condition. The main goal is to find out if adding DZP to their current standard treatments can lead to important, long-lasting improvements in their symptoms and overall health. Researchers will also be carefully checking for any side effects to make sure the treatment is safe. This is a Phase 3 study, meaning it's a key step in understanding if DZP could become a new treatment option for people with lupus.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

450

Start

21 Nov 2024

Estimated completion

31 May 2028

Systemic Lupus Erythematosus

What is this study about?

This study is particularly focused on understanding a new medication called dapirolizumab pegol, or DZP, for treating lupus (Systemic Lupus Erythematosus). Lupus is a long-term condition where the body's immune system mistakenly attacks its own healthy tissues. This can cause inflammation and damage to many different parts of the body, leading to a wide range of symptoms.

The main purpose of this research is to see how well DZP works when given alongside the treatments people with lupus usually receive. The study wants to find out if this new drug can significantly and consistently reduce the activity of lupus and improve how participants feel over an extended period. Researchers will be looking for real and lasting improvements in symptoms, and they will also be closely monitoring participants to make sure the treatment is safe.

To do this, some participants will receive DZP, and others will receive a placebo – which looks like the study drug but contains no active medicine. This is a common and important way to fairly assess if the new drug is truly effective. By taking part, you would be contributing to valuable research that could potentially help many people living with lupus in the future.

Key takeaways

This study is testing a new drug (DZP) for moderate to severe lupus.
DZP would be given alongside your current lupus treatments.
The study aims to see if DZP can improve lupus symptoms and is safe.
Participants will receive either DZP or a placebo, and regular health checks.
It's a 'Phase 3' study, meaning it's a crucial step in drug development.
Participation could help advance treatments for lupus.

Who may be eligible?

To join this study, you generally need to be at least 16 years old. If you're in China, you'll need to be 18 or older. You must have been diagnosed with lupus at least 24 weeks before the start of the study by a doctor.

Your lupus needs to be moderately to severely active, either because it's been active for a while or because you've had a recent flare-up, even though you're taking your usual medications. Doctors will do some tests to confirm your lupus diagnosis and its activity, including checking for specific markers in your blood.

Crucially, you must already be receiving standard treatments for lupus, as this study is testing DZP as an add-on to your current care, not as a replacement.

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 at least 16 years old (or 18+ in China)?
Have you been diagnosed with lupus by a doctor at least 6 months ago?
Do you currently have moderate to severe lupus activity or frequent flare-ups?
Are you already receiving standard medication for your lupus?
Do you have specific blood test results related to lupus that doctors will need to check?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first go through a screening process to make sure you meet all the requirements. This involves various checks and tests. Once accepted, you would either receive the study drug (dapirolizumab pegol, or DZP) or a placebo, which looks identical but has no active medication. Neither you nor your study doctor would know which you are receiving, which helps ensure fair results.

You would continue to take your regular lupus medications throughout the study. Your participation would involve regular visits to the clinic for medical examinations, blood tests, and to discuss any symptoms or side effects you might experience. These visits help the study team monitor your health and how the treatment is affecting your lupus. The total length of the study, including all follow-up, would be discussed in detail during your initial consultation.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and risks. A possible benefit of joining this study is that you might receive access to a new medication (DZP) that could potentially improve your lupus symptoms more than your current treatment alone. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee the study drug will work for you, and you might receive the placebo. Possible risks could include side effects from the study medication, which will be carefully monitored, and the inconvenience of extra clinic visits and tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (229)

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

Sl0044 50058
Verified postcode
Avondale, United States· Recruiting
Sl0044 50550
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Chandler, United States· Recruiting
Sl0044 50713
Verified postcode
Gilbert, United States· Recruiting
Sl0044 50662
Verified postcode
Glendale, United States· Recruiting
Sl0044 50052
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Phoenix, United States· Recruiting
Sl0044 50677
Verified postcode
Scottsdale, United States· Recruiting
Sl0044 50670
Verified postcode
Searcy, United States· Recruiting
Sl0044 50737
Verified postcode
Beverly Hills, United States· Recruiting
Sl0044 50775
Verified postcode
Beverly Hills, United States· Recruiting
Sl0044 50257
Verified postcode
La Jolla, United States· Recruiting
Sl0044 50275
Verified postcode
La Palma, United States· Recruiting
Sl0044 50755
Verified postcode
Los Alamitos, United States· Recruiting

Common questions

What is systemic lupus erythematosus (SLE)?

SLE, or lupus, is a long-term condition where your body's immune system mistakenly attacks healthy tissues, causing inflammation and damage in places like joints, skin, kidneys, and heart.

What is dapirolizumab pegol (DZP)?

DZP is a new experimental medication being tested in this study. It's designed to work differently from current lupus treatments by targeting specific parts of the immune system.

What does 'add-on treatment' mean?

It means you would continue taking your regular lupus medications as prescribed by your doctor, and DZP (or the placebo) would be given in addition to those existing treatments.

Will I know if I'm getting the actual drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving DZP or the placebo. This helps ensure the study results are accurate and unbiased.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

How to find out more

UCB Cares

ucbcares@ucb.com 1-844-599-2273 Official trial record

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