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

1 1

What is this study about?

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Spitalul Clinic Colentina Bucuresti Bucharest Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Saint Maria Hospital Bucharest Romania
Delta Health Care S.R.L. Bucharest Romania
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Diagnostics And Consultancy Center Sveti Georgi EOOD Haskovo Bulgaria
Haxumxrd Ucdcwoqtkzgxy Rwhiusvw Dk Mruwvq Malaga Spain
Lagnx Gfwvifp Hvwgbbkg Oj Acaude Athens Greece
Apuqkgv Ccevxsd Snhyfk Bucharest Romania
Hhlrgkwz Uhsxvcbpcidub df A Cdevdq A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
10.01.2023
Greece Greece
Not recruiting
10.01.2023
Poland Poland
Not recruiting
10.01.2023
Romania Romania
Not recruiting
10.01.2023
Spain Spain
Not recruiting
10.01.2023

Trial locations

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.

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.

Trial ID:
2024-510871-39-00
Protocol code:
MS200569_0048
NCT ID:
NCT05540327
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Czechia Denmark Finland France Germany +9
  • Study on the Effectiveness and Safety of Deucravacitinib for Patients with Active Systemic Lupus Erythematosus (SLE)

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Czechia Greece Hungary Poland Portugal +1