A Phase 3 interventional study of Enpatoran in Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), sponsored by EMD Serono Research & Development Institute, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by EMD Serono Research & Development Institute, Inc. (part of Merck KGaA, Darmstadt, Germany) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001) (NCT07332481) and Elowen-2 (MS504908_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include:
Study Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120).
Study Intervention: Enpatoran. Intervention Form: Film-coated tablet.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 404 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →EMD Serono Research & Development Institute, Inc. is the lead sponsor of 87 studies on the registry; 8 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 38 (81%) have results posted.
First submitted after EMD Serono Research & Development Institute, Inc. became part of Merck KGaA, Darmstadt, Germany.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus [SARS CoV] 2), bacterial (including active tuberculosis or untreated latent tuberculosis), parasitic, or fungal infection or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary.
Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Enpatoran
Participants will receive a dose of Enpatoran orally for 108 weeks.
Also known as: M5049
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Time frame: From current LTE study Day 1 to Week 120
Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)
Time frame: From current LTE study Day 1 to Week 120
Number of Participants With Abnormalities in Vital Signs
Time frame: From current LTE study Day 1 to Week 120
Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter
Time frame: From current LTE study Day 1 to Week 120
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline
Elowen-1 (MS504908\_0001) (NCT07332481) / Elowen-2 (MS504908\_0008) (NCT07355218) study Baseline values will be used as a reference for calculation.
Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With CLASI-50 Response, Defined as >= 50% Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline
Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.
Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With CLASI-A less than and equal to (<=) 3
CLASI-A assesses the signs of CLE disease activity including erythema, scale/hypertrophy, mucous membrane lesions, hair loss and alopecia. Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.
Time frame: From current LTE study Day 1 to Week 108
Change From Elowen-1/Elowen-2 Study Baseline in Worst Itch Numeric Rating Scale (NRS) Through LTE Week 108
The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from 0 (No itch) to 10 (Worst imaginable itch). Elowen-1/Elowen-2 study Baseline values will be used a reference to calculate change.
Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With Worst Itch Response Through LTE Week 108 Based on Elowen-1/Elowen-2 study Baseline
Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.
Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With CLA-IGA-R Other Morphological Characteristics (OMC) Score of 0 or 1 and at Least a 1-Point Reduction From Elowen 1/Elowen-2 study Baseline to LTE study Week 108
Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.
Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response
A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[\<=\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and \<= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than \[\<\] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment).
Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With Mild/Moderate and Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare
Time frame: From current LTE study Baseline to Week 108
Time to First Severe SELENA-SLEDAI Flare
Median time to first severe SELENA-SLEDAI flare will be calculated.
Time frame: From current LTE study Baseline to Week 108
Percentage of Participants with BILAG Moderate to Severe Flares
Time frame: From current LTE study Baseline to Week 108
Time to First Moderate/Severe BILAG Flare
Median time to first moderate or severe BILAG Flare will be calculated.
Time frame: From current LTE study Baseline to Week 108
Percentage of Participants With Lupus Low Disease Activity State (LLDAS) Attainment
Time frame: From LTE study Day 1 to Week 108
Percentage of Participants With Sustained LLDAS
Time frame: From LTE study Day 1 to Week 108
Change in Prednisone-equivalent Corticosteroid (CS) Dose From Elowen-1/Elowen-2 Study Baseline to LTE Study Week 108
Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.
Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108
Percentage of Participants With CS Reduction of Daily Prednisone Equivalent Dose
Elowen-1/Elowen-2 study Day 1 values will be used as a reference for calculation.
Time frame: Elowen-1/Elowen-2 study Day 1, current LTE study Week 108
Plan to share: Yes — IPD supporting publicly available results will be evaluated for sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: IPD from completed trials will be publicly available within 6 months after all of the following events: Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions Public results via primary manuscript or trial registry disclosure Legal authority to share data Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21
Access criteria: Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.
Data sharing details ↗ · vivli.org
Started Oct 2026 (actual). Primary completion is estimated for Sep 2031, 58 months after the start.
Of 53 phase 3 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 84. This study's planned 58 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Enpatoran
Lupus Erythematosus, Systemic →
EMD Serono Research & Development Institute, Inc. →