Study of Enpatoran in Adults with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE)

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What is this study about?

This clinical study focuses on Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), which are autoimmune conditions where the body’s immune system attacks its own tissues. SLE can affect multiple organs throughout the body, while CLE primarily affects the skin, causing rashes and lesions. The study will test a new medication called enpatoran in patients who are already receiving standard treatments for lupus.

The purpose of this research is to evaluate how different doses of enpatoran work in reducing disease activity, particularly focusing on skin symptoms and overall disease control. During the study, participants will receive either enpatoran tablets or placebo in addition to their current lupus medications. The study will track changes in participants’ symptoms and overall health for up to 24 months.

This is a Phase 2 study, which means the medication has already been tested for basic safety in humans, and researchers are now studying how well it works at different doses. The study is designed to be double-blind, which means neither the participants nor the healthcare providers will know who is receiving enpatoran or placebo during the study period.

1 Initial assessment

Your participation begins with an evaluation to confirm active cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE).

The medical team will assess your condition using specific measurement tools to determine disease activity levels.

2 Group assignment

You will be randomly assigned to either receive enpatoran or a placebo (inactive tablet).

Both medications come in the form of film-coated tablets for oral use.

You will continue your current standard lupus treatments throughout the study.

3 Treatment period – first 16 weeks

You will take the assigned medication as prescribed.

Regular assessments will track changes in your skin symptoms using a measurement called CLASI-A.

The medical team will monitor your overall health and any potential side effects.

4 Extended treatment period – up to 24 weeks

Treatment continues with regular monitoring of your condition.

Additional assessments will measure various aspects of disease activity.

Your fatigue levels and quality of life will be evaluated using specific questionnaires.

5 Final evaluation

A comprehensive assessment of your response to treatment will be conducted.

The medical team will evaluate any changes in your condition since the start of the study.

All safety-related information will be recorded and reviewed.

Who Can Join the Study?

  • Patient must have active cutaneous lupus erythematosus (a skin form of lupus) with a disease activity score (CLASI-A) of 8 or higher
  • Patient must have active systemic lupus erythematosus meeting one of these conditions:
    • Skin disease score (CLASI-A) of 8 or higher with moderate disease activity in other organs
    • Severe or moderate disease activity in multiple organs
    • Disease activity score (SELENA-SLEDAI) of 6 or higher during screening
  • Patient must be currently taking at least one of these stable treatments for lupus:
    • Medications that modify the immune system
    • Oral steroids
    • Topical steroids (applied to skin)
  • Patient can be male or female
  • Patient must be an adult (18 years or older)
  • Additional eligibility requirements may apply based on study protocol

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous participation in any clinical trial within past 30 days
  • Pregnancy or breastfeeding
  • Known hypersensitivity (severe allergic reaction) to the study medication or its components
  • Active or chronic infections, including tuberculosis or hepatitis B or C
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe kidney disease (defined as creatinine clearance below 30 mL/min)
  • Severe liver disease (defined as liver enzyme levels more than 2 times above normal)
  • Unstable heart conditions or recent heart attack (within past 6 months)
  • Uncontrolled high blood pressure (blood pressure above 160/100 mmHg)
  • History of blood clots or thromboembolism (blood clots that travel through blood vessels)
  • Current treatment with medications that could interfere with the study drug
  • Mental health conditions that could interfere with study participation
  • Drug or alcohol abuse within the past year
  • Any condition that, in the opinion of the study doctor, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Twoja Przychodnia Opolskie Centrum Medyczne Opole Poland

Other Sites

Site Name City Country Status
Saint Maria Hospital Bucharest Romania
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Rio Hortega Valladolid Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
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
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Hospital Quironsalud Sagrado Corazon Sevilla Spain
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Centrul Medical Monza S.R.L. Bucharest Romania
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Bialystok Poland
Hippokration Hospital Athens Greece
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Spitalul Clinic Colentina Bucuresti Bucharest Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Hospital General Universitario De Castellon Castello De La Plana Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medical Center Artmed Ltd. Plovdiv Bulgaria
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Hykndxcl Ursuxztgorutr Melxodp Dn Vywjiezhvu Santander Spain
Lfqlp Gwmeust Holtptpa On Atnqgv Athens Greece
Pfukkvpp Paxhwoxj Lwqciakk Pqfz Df Hlv Mce Pvgxi Hokkqf Poznan Poland
Mfaxnkqc Mjilkwi Arwqsvu Pleven Bulgaria
Hoyynvrg Umshdlxorsomx da A Chjpyv 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
15.06.2022
Greece Greece
Not recruiting
15.06.2022
Poland Poland
Not recruiting
15.06.2022
Romania Romania
Not recruiting
15.06.2022
Spain Spain
Not recruiting
15.06.2022

Trial locations

Investigated drugs:

Enpatoran is an investigational medication being studied for treating people with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (including subacute cutaneous lupus erythematosus and discoid lupus erythematosus). It is designed to help reduce disease activity and symptoms in people with these autoimmune conditions. This medication works by targeting specific components of the immune system that are involved in lupus.

Standard of care treatments are also used in combination with Enpatoran. These are the usual medications that patients with lupus already take as part of their regular treatment plan, which may include anti-inflammatory drugs, antimalarial medications, or other immune system medications.

Systemic Lupus Erythematosus (SLE) – A chronic autoimmune disease where the body’s immune system attacks its own tissues and organs. The condition can affect multiple body systems, including joints, skin, kidneys, blood cells, brain, heart, and lungs. Symptoms often develop slowly and can vary from mild to severe, with periods of flares alternating with periods of remission. Common symptoms include fatigue, joint pain, skin rashes, and fever.

Cutaneous Lupus Erythematosus (CLE) – A form of lupus that primarily affects the skin, causing rashes and lesions, particularly in sun-exposed areas. The condition can present as red, scaly patches that may cause discomfort and itching. These skin manifestations can range from mild to severe and may leave scarring or pigmentation changes. CLE can occur on its own or as part of systemic lupus erythematosus.

Trial ID:
2024-510872-18-00
Protocol code:
MS200569_0003
NCT ID:
NCT05162586
Trial Phase:
Therapeutic exploratory (Phase II)

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