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

Verified siteInvestigational

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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Verified
Cracow, Poland
Hippokration Hospital
Verified
Athens, Greece
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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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.

Enpatoran

What is already known about the treatment

Enpatoran - An investigational medication being studied in Phase 2 clinical trials for the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). The drug is being evaluated for its ability to reduce disease activity in patients who are already receiving standard care treatments. While the exact mechanism of action is still under investigation through clinical trials, enpatoran is being studied in different doses to determine its effectiveness and safety profile in managing both systemic and skin-specific symptoms of lupus. The medication represents a new potential treatment option being developed specifically for lupus patients, with research focusing on its impact on reducing visible skin manifestations as measured by standardized assessment tools.

Investigated diseases

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.