RecruitingPHASE3INTERVENTIONAL

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

This research study, called ELOWEN-2, is testing a new tablet medicine called Enpatoran. It's for people aged 18 to 75 who have lupus, especially when it causes rashes and problems on their skin (called cutaneous lupus). Some participants might also have lupus affecting other parts of their body. The study wants to find out if Enpatoran is effective in reducing skin symptoms and if it's safe to use. Some participants will receive Enpatoran, others a dummy tablet (placebo), and some will continue with their usual treatment. This is a large study taking place in different locations around the world, and it will last for about 35 weeks.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

202

Start

01 Apr 2026

Estimated completion

25 May 2029

Systematic Lupus Erythematosus Cutaneous Lupus Erythematosus

What is this study about?

This study, called ELOWEN-2, is looking into a new medication named Enpatoran. It's designed for people who have lupus that shows up on their skin, causing rashes or other problems. Some people in the study might also have lupus affecting other parts of their body, not just the skin. The main goal is to check if Enpatoran can help improve these skin symptoms and if it's safe for people to take. It's a 'Phase 3' study, which means it's one of the final steps in testing a new medicine before it might become available more widely.

Participants will be given either the new medicine, Enpatoran, a 'placebo' (a dummy tablet that looks like the medicine but has no active ingredients), or they will continue with their current usual care. This helps the researchers compare Enpatoran's effects fairly. The study will last for up to 35 weeks, with the treatment portion lasting 24 weeks, and participants will visit the clinic or have a video call about once a month.

Finding new and better ways to manage lupus, especially the skin problems, is really important for people living with this condition. This study helps gather vital information to see if Enpatoran could be a helpful new treatment option.

Key takeaways

This study is testing a new tablet medicine, Enpatoran, for skin problems caused by lupus.
It's open to people aged 18-75 with lupus affecting their skin, with or without systemic lupus.
Participants will take Enpatoran, a placebo, or continue standard care for 24 weeks.
The study lasts up to 35 weeks with monthly visits, including some video calls.
It aims to see if Enpatoran is safe and effective for improving skin symptoms in lupus.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for people aged between 18 and 75 years old. You might be able to join if you have been diagnosed with a type of lupus that affects your skin, such as discoid lupus (DLE), subacute cutaneous lupus (SCLE), or acute cutaneous lupus (ACLE). You can be considered whether or not your lupus also affects other parts of your body (systemic lupus).

To be eligible, your skin lupus needs to be active and bothering you at the start of the study. You also need to have had your lupus diagnosis for at least 6 months. It's important that your routine vaccinations are up-to-date.

However, you wouldn't be able to join if you have other main autoimmune diseases (like rheumatoid arthritis or scleroderma), or if your lupus is causing severe, life-threatening problems. You also can't participate if your lupus was caused by a medicine, or if you have certain other serious health conditions that might make taking part risky.

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?
Do you have a type of lupus that causes skin problems (like DLE, SCLE, or ACLE)?
Are your skin problems from lupus currently active?
Have you been diagnosed with lupus for at least 6 months?
Are your routine vaccinations up to date?
Do you *not* have other major autoimmune diseases (e.g., rheumatoid arthritis)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in it for up to 35 weeks. For 24 of those weeks, you'll be taking a film-coated tablet, either Enpatoran (the study medicine) or a placebo (a dummy tablet without medicine). You will have regular check-ups, usually every 4 weeks. Most of these will be in person, but one visit at Week 2 might be a video call (televisit). During these visits, the study team will monitor your health, how your skin lupus is doing, and check for any side effects. After the 24 weeks of treatment, there will be follow-up visits to make sure you're doing well.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as gaining access to a new medicine that might improve your skin symptoms, and receiving close medical attention from a specialist team. However, there are also potential risks, including side effects from the study medicine or the possibility that the medicine might not work for you. You might also receive the placebo. You will be given more detailed information about possible side effects before you decide to join. Remember, taking part in any clinical study is always voluntary, and you have the right to withdraw at any time without explaining why, and it won't affect your usual medical care.

Locations (57)

Inland Rheumatology Clinical Trials, Inc.
Verified postcode
Upland, United States· Recruiting
Omega Research Debary, LLC
Verified postcode
DeBary, United States· Recruiting
Centre for Rheumatology, Immunology and Arthritis
Verified postcode
Fort Lauderdale, United States· Recruiting
South Florida Rheumatology
Verified postcode
Hollywood, United States· Recruiting
GTL Medical And Research Group
Verified postcode
Miami, United States· Recruiting
Bolanos Clinical Research
Verified postcode
Pembroke Pines, United States· Recruiting
Vantage Clinical Trials
Verified postcode
Tampa, United States· Recruiting
Dawes Fretzin Clinical Research Group, LLC
Verified postcode
Indianapolis, United States· Recruiting
Accurate Clinical Research Inc. - Lake Charles
Verified postcode
Lake Charles, United States· Recruiting
Oakland Hills Dermatology
Verified postcode
Auburn Hills, United States· Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas II, LLC
Verified postcode
Charlotte, United States· Recruiting
Superior Clinical Research, LLC
Verified postcode
Smithfield, United States· Recruiting

Common questions

What is lupus?

Lupus is a long-term (chronic) illness where the body's immune system mistakenly attacks its own healthy tissues, which can cause inflammation and damage in various body parts, including the skin, joints, and organs.

What is 'cutaneous lupus'?

Cutaneous lupus refers to lupus that mainly affects the skin, causing rashes, sores, or other skin problems. It can happen on its own or alongside lupus that affects other parts of the body.

What is 'Enpatoran'?

Enpatoran is the new medicine being tested in this study. It's a tablet designed to help with the skin problems caused by lupus.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks just like the study medicine but contains no active ingredients. It helps researchers fairly compare the new medicine's effects against doing nothing.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor the study team will know who is getting the active medicine and who is getting the placebo. This is to make sure the results are as fair and unbiased as possible.

How to find out more

US Medical Information

emediusa@emdserono.com 888-275-7376 Official trial record

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