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New treatment option for Systematic Lupus Erythematosus
Official title A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
ClinicalTrials.gov ID: NCT07355218
What this study is testing
What is Enpatoran?
Enpatoran is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for systematic lupus erythematosus.
Also referred to as M5049.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history...
- Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be...
- Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR)...
- Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.
You likely can't join if
- Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus...
- Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled...
- Participants with drug-induced lupus (SLE or CLE).
- Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable...
- Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular...
- Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any...
See the full eligibility criteria
- Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).
- Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.
- Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or...
- Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.
- Participants with disease duration (cutaneous disease and, where applicable, SLE) of \>= 6 months from time of diagnosis to Screening.
- Participants with CLASI-A score \>= 8 at Screening and Day 1 visits.
- Other protocol-defined may apply.
- Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.
- Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial...
- Participants with drug-induced lupus (SLE or CLE).
- Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral...
- Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square...
- Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.
- Other protocol-defined exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Upland, California, United States
- DeBary, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Lake Charles, Louisiana, United States
- Auburn Hills, Michigan, United States
- Charlotte, North Carolina, United States
- Frisco, Texas, United States
- Humble, Texas, United States
- Kelowna, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Upland, California, United States; DeBary, Florida, United States; Hollywood, Florida, United States; Miami, Florida, United States; Pembroke Pines, Florida, United States; Tampa, Florida, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.