Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care

This study, called a Phase 2 trial, is looking into a new medicine called Enpatoran for adults who have systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE), which includes conditions like subacute cutaneous lupus and discoid lupus. Participants will receive either Enpatoran or a placebo (a dummy drug) in addition to their usual care. Researchers want to find out if Enpatoran is safe and effective in improving lupus symptoms, particularly skin problems and overall disease activity. They are also trying to find the best dose to use. This information will help decide if Enpatoran should be studied further in larger trials.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Healthcare KGaA

Enrolment target

127

Start

11 Jun 2024

Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study involving volunteers to test new medical treatments. In this case, doctors are testing a new medicine called Enpatoran for people with lupus. Lupus is a long-term condition that can cause inflammation and damage to various parts of the body. There are different types, and this study focuses on two main types: systemic lupus erythematosus (SLE), which can affect many organs, and cutaneous lupus erythematosus (CLE), which mainly affects the skin.

The main goal of this study is to see if Enpatoran can help reduce the symptoms of lupus, especially skin problems for those with CLE, and generally improve how people feel with SLE. They also want to understand if the medicine is safe and if there are any side effects. Because it's a 'dose-ranging' study, they are also trying to find the best amount of medicine to give to patients. Participants will be splitting into groups, with some receiving the active medication and others receiving a 'placebo' – a dummy pill that looks just like the study drug but contains no active ingredients. This helps researchers fairly compare the new drug's effects.

This is a Phase 2 study, which means it builds on earlier research that showed the drug was likely safe in a small number of people. Now, they are studying it in a larger group of people with the condition to get a better idea of its effectiveness and safety before potentially moving on to an even larger Phase 3 trial.

Key takeaways

This study is testing a new drug, Enpatoran, for both whole-body (SLE) and skin-focused (CLE) lupus.
It aims to check if Enpatoran is safe and helpful for improving lupus symptoms.
Participants will receive either Enpatoran or a placebo, in addition to their usual lupus treatment.
The study also wants to find the best dose of Enpatoran.
It's a 'Phase 2' study, meaning it's an earlier-stage trial to gather important safety and effectiveness information.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years or older. The study is open to both men and women.

More specifically, you'd need to have been diagnosed with either systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE). For CLE, this includes specific types like subacute cutaneous lupus erythematosus or discoid lupus erythematosus. Crucially, you would also need to be receiving your usual, standard medical care for your lupus condition.

There will be other detailed criteria that medical staff will check to make sure the study medication is safe and appropriate for you. This might include information about your general health, other medications you take, and how severe your lupus is. They want to make sure the study is a good fit for all participants.

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 18 years old or older?
Have you been diagnosed with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE)?
Are you currently receiving regular medical treatment for your lupus?
Are you able to attend regular clinic appointments for the duration of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to a clinic or hospital over several months. At these appointments, the study team would perform various checks. This could include physical examinations, blood tests, and possibly skin checks to monitor your lupus symptoms. You would also be asked to complete questionnaires about your health and how you are feeling.

You would receive either the study drug, Enpatoran, or a placebo, which looks identical but has no active medicine. This would be in addition to your current lupus treatments. The study also involves follow-up appointments after you stop taking the study medication to ensure your health is stable. The total time you'd be involved in the study would depend on which group you are in, but these types of studies often last several months, potentially up to a year or more, including follow-up periods.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new, experimental treatment that might improve your condition, or contributing to medical knowledge that could help others in the future. However, there are also potential risks; Enpatoran is a new medicine, so not all side effects are fully known, and you might experience unwanted reactions or no improvement in your condition. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Greece
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Unverified
Romania
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Unverified
Poland
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Unverified
Bulgaria

Common questions

What is systemic lupus erythematosus (SLE)?

SLE is a long-term illness where your immune system mistakenly attacks your own body, causing inflammation in various organs like joints, skin, kidneys, or brain.

What is cutaneous lupus erythematosus (CLE)?

CLE is a type of lupus that mainly affects the skin, causing rashes, sores, or lesions, often in areas exposed to the sun.

What is a 'placebo' in a study like this?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the true effects of the new medicine.

What does 'Phase 2' mean for a clinical trial?

Phase 2 trials test a new treatment in a larger group of people than earlier studies to see if it's safe and effective, and to find the best dose, before moving to even larger trials.

Will I still take my regular lupus medicines during the study?

Yes, participants in this study will continue to receive their standard, usual medical care for their lupus condition alongside the study medication (Enpatoran or placebo).