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Evaluation of Long-term Safety and Efficacy of Enpatoran in Subacute Cutaneous, Discoid, and Systemic Lupus Erythematosus Post-WILLOW Study Completion

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Enpatoran in individuals with certain types of lupus. Lupus is a disease where the immune system attacks healthy tissues, and it can affect the skin, known as cutaneous lupus erythematosus (CLE), or the entire body, known as systemic lupus erythematosus (SLE). The study includes people who have subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and/or systemic lupus erythematosus. The purpose of the study is to evaluate the long-term safety and tolerability of Enpatoran in these participants.

Participants in the study will receive either the medication Enpatoran or a placebo, which looks like the medication but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will be conducted over a long period, allowing researchers to gather information on how well the medication is tolerated and any side effects that may occur.

Throughout the study, participants will be monitored for any adverse events, which are unexpected medical problems that occur during treatment. The study will also look at any changes in laboratory tests and heart function, specifically the QT interval, which is a measure of the heart's electrical activity. This information will help determine the safety profile of Enpatoran for people with lupus. Participants who successfully complete the initial part of the study may have the opportunity to continue in a long-term extension of the study to gather more data on the medication's effects.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry
You enter the long-term extension study after completing treatment in the earlier WILLOW study.
The study is double-blind, which means that the treatment assigned to you is not identified during the study.
The study is dose-ranging, which means that different doses may be studied.
The study has part 1 and part 2.
Step 2
Study treatment
You receive either enpatoran or placebo. A placebo is a tablet with no active medicine.
Enpatoran is taken by mouth as a film-coated tablet. The dose listed is 00 mg.
The treatment is given once daily.
The treatment continues for the long-term study period. The exact duration is not specified in the source data.
Step 3
Safety checks during the study
Your safety is monitored during part 1 and part 2.
The study records treatment-emergent adverse events (TEAEs), which are health problems that appear or become worse after treatment starts.
The study records serious adverse events (SAEs), which are more serious health problems.
The study records adverse events of special interest (AESIs), which are specific health problems the study is watching closely.
The study also checks for abnormalities in laboratory parameters, which means results from blood or other laboratory tests that are outside the normal range.
The study also checks the qt interval corrected, which is a measurement from a heart test that shows how the heart is working.

Who can join the trial?

6 criteria

Be 18 to 76 years old when signing the consent form, which is the document that gives permission to join the study.
Have active SCLE, DLE, and/or SLE and have already completed the 24-week Treatment of the Willow Study.
Have a body mass index (BMI) of 40 or higher at screening. BMI is a number based on height and weight.
Have successfully completed Week 48 of Part 1 to be able to join Part 2.
In special cases, people who completed the Week 48 visit of Part 1 within the previous 4 weeks may still be considered for Part 2 after eligibility review.
Meet any other study rules required by the protocol, which is the official study plan.

Who cannot join the trial?

12 criteria

Any person who had a serious event related to the study treatment during the WILLOW study cannot take part. A serious event means a harmful or dangerous medical problem caused by the study treatment.
Any person with another severe acute or chronic medical or mental health condition that could increase the risk of joining the long-term study cannot take part. Acute means short-term and sudden. Chronic means long-lasting.
Any person with an abnormal laboratory test result that could make participation unsafe cannot take part. Laboratory tests are blood, urine, or other medical tests.
Any person with an ongoing or active clinically significant infection cannot take part. Clinically significant means serious enough to matter medically.
Any person with a current or active viral infection, including SARS-CoV-2 (the virus that causes COVID-19), cannot take part.
Any person with a current or active bacterial infection cannot take part.
Any person with a current or active fungal infection cannot take part.
Any person who had a major infection that needed hospitalization cannot take part while that situation affects study safety. Hospitalization means staying in the hospital for treatment.
Any person who took a medication that was not allowed in the long-term extension study during the WILLOW study cannot take part.
Any person who took a medication that was not allowed after Week 24 of the WILLOW study cannot take part.
Any person who joined another investigational drug study after Week 24 of the WILLOW study cannot take part. Investigational drug means a medicine still being tested and not yet approved for general use.
Any other exclusion rule written in the study plan may also prevent a person from taking part.

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Verified sites

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Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Cracow, Poland
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Hospital Universitario da A Coruna
A Coruna Galicia, Spain
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Laiko General Hospital Of Athens
Athens, Greece

Trial locations

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Investigated drugs

Enpatoran is the study medicine being tested in this trial. It is an oral tablet taken by mouth. The trial is looking at whether enpatoran is safe to use over a longer time and how well it may help people with lupus-related skin disease and/or systemic lupus erythematosus. Researchers are also checking how well people can tolerate it during extended treatment and whether it may help control symptoms.

Enpatoran

What is already known about the treatment

Enpatoran
Enpatoran is taken by mouth as a film-coated tablet, which means it is swallowed with water. It is an experimental medicine in current medical research and is not yet a standard treatment in routine care, but it has been studied for lupus-related skin and body symptoms. It is being developed to help people with systemic lupus erythematosus and cutaneous lupus erythematosus by calming an overactive immune response; it is thought to block signals from toll-like receptors 7 and 8, which are parts of the immune system that can drive inflammation. Pharmacologically, it is an immune system modulator and a targeted anti-inflammatory medicine.
Enpatoran Placebo
Enpatoran placebo is given by mouth in the same way as the study tablet, but it does not contain the active medicine. It is used in clinical trials to compare results fairly and helps researchers understand whether any benefits or side effects come from enpatoran itself rather than from expectations or chance. A placebo has no direct therapeutic effect and does not work through a biological mechanism, but it is an important control in medical research. It is not a real medicine and has no pharmacological class because it contains no active substance.

Investigated diseases

Systemic lupus erythematosus
A chronic autoimmune disease in which the immune system attacks healthy tissues, causing inflammation that can affect the skin, joints, blood cells, kidneys, and other organs. It often develops in periods of flare-ups and remissions, with symptoms that may change over time and involve several body systems.
Cutaneous lupus erythematosus
A form of lupus that mainly affects the skin and causes areas of rash, redness, scaling, or sensitivity to sunlight. It may appear in recurring episodes, and the skin changes can persist, spread, or leave lasting marks as the disease continues.