ELOWEN-1

Summary

Lupus is a chronic disease that can cause inflammation and pain in any part of the body. It's an autoimmune disease, which means that the immune system attacks healthy tissue instead. Lupus most commonly affects the skin, joints, internal organs (like kidneys and heart). Because lupus affects many parts of the body, it causes many different symptoms, including fatigue, pain and swelling in the joints, headaches, and low fevers. Skin-associated lupus symptoms include a butterfly-shaped rash on the checks and nose, hair loss, sores in the mouth or nose, and Raynaud syndrome (which causes fingers and toes to change color or feel numb when a person is cold or stressed). Skin involvement occurs in around 85% of people with lupus.

The ELOWEN-1 study investigates the safety and efficacy of a new medicine, enpatoran, in participants with active skin issues due to lupus. The hope is that enpatoran help with overall disease control while targeting the visible skin manifestations. Participants enrolled in ELOWEN-1 are assigned randomly (50:50, like a coin toss) to receive either enpatoran or a pill that looks identical but does not contain any medicine. Neither the lead scientist nor participants can choose which study group they're assigned to. Participation in ELOWEN-1 will last up to 35 weeks, including treatment and clinic visits.

To be included in ELOWEN-1, participants must be / have

• Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
• Documented diagnosis of discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE).
• Active acute CLE as the sole cutaneous manifestation is eligible, when present with SLE and for at least 6 weeks prior to the screening visit.

To be included in ELOWEN-1, participants musts must not be / have

• Primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than CLE and SLE
• Drug-induced SLE or CLE
• Active lupus nephritis on induction therapy or completed within 3 months of the screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed)
• Abnormal kidney function defined as urine protein-to-creatinine ratio (UPCR) greater than 339 mg/mmol and/or estimated glomerular filtration rate (eGFR) less than 40 mL/min/1.73 m2
• Any active signs, symptoms, or diagnoses considered related to central nervous system lupus within the past 3 months or any history of uncontrolled seizures

Keywords
Cutaneous lupus erythematosus; Discoid lupus erythematosus; Systemic lupus erythematosus; Lupus