Phase 3 Study of Enpatoran in Patients with Active Cutaneous Lupus Erythematosus (with or without Systemic Disease)

3 1

What is this study about?

The condition being studied is Cutaneous Manifestations of Lupus Erythematosus, an autoimmune disease that can cause red, scaly patches on the skin and may occur with or without involvement of internal organs. The investigational medication is Enpatoran, an oral tablet taken daily, and it is being compared with a matching placebo. The purpose of the study is to determine whether Enpatoran can significantly reduce skin disease activity, defined as at least a 70% improvement in a skin severity score.

Participants are randomly assigned to receive either Enpatoran or placebo for a period of 24 weeks while continuing any usual care. The skin severity is measured using the CLASI score, which rates the extent and intensity of rash, and overall lupus activity is also evaluated with the BICLA assessment. Throughout the study, safety is monitored by recording any adverse events and laboratory changes. Visits occur at regular intervals to collect the necessary information and to ensure participant well‑being.

1 randomization and baseline assessment

after joining the study, you will be assigned to receive either enpatoran or a matching placebo without knowing which one you receive.

a baseline visit will be performed to record your skin condition using the cutaneous lupus erythematosus disease area and severity index (clasi-a) and to collect routine laboratory tests.

2 start of study medication

you will begin taking an oral, film‑coated tablet each day.

the tablet contains either enpatoran hemihydrate or an inactive substance (placebo); the exact dose is defined by the study protocol.

the medication will be taken for a total period of 24 weeks.

3 regular safety monitoring

throughout the 24‑week period you will be asked to report any new symptoms, side effects, or changes in health.

routine laboratory tests may be performed at scheduled visits to check for significant changes.

4 interim efficacy assessment at week 4

a follow‑up visit will occur at week 4 to repeat the clasi-a skin assessment and to evaluate any early response to the medication.

5 mid‑study assessment at week 12

another visit will be scheduled at week 12 to assess skin improvement, review laboratory results, and determine whether the dose of any concomitant corticosteroid medication can be reduced.

6 final assessment at week 24

the last study visit will take place at week 24.

the primary goal is to determine whether a reduction of at least 70% in the clasi-a score has been achieved.

secondary goals include evaluating overall lupus activity, safety outcomes, and any reduction in corticosteroid use.

7 study completion

after the week 24 visit, the study medication will be stopped and you will receive any necessary follow‑up care as directed by your physician.

Who Can Join the Study?

Age: You must be between 18 and 75 years old.
Vaccinations: Your routine vaccinations must be up to date according to local guidelines; a shingles vaccine (recombinant zoster) is encouraged but not required.
Diagnosis of skin lupus: You need a documented diagnosis of Discoid Lupus Erythematosus (a type of chronic skin rash) and/or Subacute Cutaneous Lupus Erythematosus (a milder, widespread skin rash), with or without Systemic Lupus Erythematosus (a disease that can affect many organs).
Acute skin flare: If the only skin problem is Acute Cutaneous Lupus Erythematosus (a sudden, severe skin flare), you must also have Systemic Lupus Erythematosus and the flare must have been present for at least 6 weeks before the screening visit.
Lupus classification criteria: If you have Systemic Lupus Erythematosus, you must meet the 2019 classification criteria set by the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR), and you must have active skin disease (Discoid, Subacute, or Acute Cutaneous Lupus).
Disease duration: Your skin disease (and, if applicable, your overall lupus) must have been diagnosed at least 6 months before the screening visit.
Skin severity score: At the screening and first study visit, you must have a CLASI‑A score (a numeric measure of skin disease activity) of 8 or higher.
Both men and women are eligible to participate.
Participants who are considered vulnerable (for example, due to age, disability, or other factors) may be included.

Who Cannot Join the Study?

People who have a primary diagnosis of another autoimmune rheumatic disease such as systemic sclerosis or rheumatoid arthritis (conditions where the immune system attacks the body’s own tissues) are not allowed.
Anyone who has skin diseases other than lupus‑related skin problems, such as psoriasis, or who has uncontrolled illnesses like asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, bronchiectasis, or pulmonary arterial hypertension, or life‑threatening lupus problems such as active systemic vasculitis (inflammation of blood vessels) is excluded.
People whose lupus was caused by a medication, known as drug‑induced lupus, cannot participate.
Patients who have active lupus nephritis (kidney inflammation caused by lupus) and are currently receiving initial high‑dose treatment (called induction therapy), or who finished that induction therapy within the last 3 months, are excluded. Ongoing stable maintenance medicines such as mycophenolate, azathioprine, or an oral calcineurin inhibitor are allowed.
Anyone with a urine test showing a Urine Protein-to-Creatinine Ratio (UPCR) higher than 339 mg/mmol, or a kidney function test showing an estimated Glomerular Filtration Rate (eGFR) below 40 mL/min/1.73 m² (a measure of how well the kidneys filter blood), is not eligible.
People who have had any active signs, symptoms, or diagnoses related to central nervous system (CNS) lupus in the past 3 months, or who have a history of uncontrolled seizures, cannot join the study.
Any other reasons defined in the study protocol that make participation unsafe or inappropriate will also exclude a person.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
University Hospital Bratislava	Bratislava	Slovakia
Hospital Quironsalud Malaga	Malaga	Spain
Artromac N.O.	Kosice	Slovakia
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda USL Toscana Centro	Prato	Italy
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Elbe Kliniken Stade-Buxtehude gGmbH	Buxtehude	Germany
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Medical Center Hera EOOD	Sofia	Bulgaria
ASMC – IPSMC – Skin And Venereal Diseases	Sofia	Bulgaria
Hospital Edouard Herriot	Lyon	France
„DCC V – Plovdiv – Sv. Archbishop Luka“ EOOD	Plovdiv	Bulgaria
DCC Sveti Georgi EOOD	Haskovo	Bulgaria
Hllduh Skz Eqaqtrgms Kuclht Ovkforitra Gauw	Oberhausen	Germany
Iemfodxr dr Clkwaycdlwwc Hgqcgzsxywt Uemavuofabzbv do Shpsb Epglutr (fhmvbuu	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	15.07.2026
Bulgaria	Not yet recruiting	15.07.2026
France	Not yet recruiting	15.07.2026
Germany	Not yet recruiting	15.07.2026
Greece	Not yet recruiting	15.07.2026
Italy	Not yet recruiting	15.07.2026
Slovakia	Not yet recruiting	15.07.2026
Spain	Not yet recruiting	15.07.2026

Trial locations

Enpatoran is an oral, film‑coated tablet being studied as a new treatment for people who have active skin involvement from lupus erythematosus, whether or not they also have disease affecting other parts of the body. In this trial the medication is taken in addition to the standard care that participants already receive. The purpose of the study is to find out if Enpatoran can lower the severity of skin disease by at least 70% after 24 weeks, compared with a placebo. Enpatoran is designed to act on the immune system to reduce the inflammation that causes the skin lesions in lupus.

Investigated diseases:

Cutaneous lupus erythematosus – Cutaneous lupus erythematosus is an autoimmune condition that causes skin inflammation and rash. The rash may appear as red patches, scaly plaques, or disc‑shaped lesions, often worsening with sun exposure. Over time, lesions can become thicker, cause pigment changes, or lead to scarring if not controlled. The disease can appear alone or together with systemic lupus, and skin symptoms may fluctuate, with periods of flare and remission. New lesions may develop in previously unaffected areas as the condition evolves.

Trial ID:

2025-523871-44-00

Protocol code:

MS504908_0001

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Phase 3 Study of Enpatoran in Patients with Active Cutaneous Lupus Erythematosus (with or without Systemic Disease)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?