Systemic Lupus Erythematosus (SLE)Phase 3NCT07840287
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
A Phase 3 study testing Enpatoran in people with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), run by EMD Serono Research & Development Institute, Inc. at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- Enpatoran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2026to 1 Sep 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit.
Who cannot join
- Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study.
- Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study.
- 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.
- All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result.
- Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor).
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- Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
- Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.
- Planned major elective medical or surgical procedure.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: A Phase 3, Single-Arm, Open-Label, Long-Term Extension Study To Evaluate The Safety And Efficacy Of Enpatoran In Participants With Active Cutaneous Manifestations Of Lupus Erythematosus With Or Without Systemic Disease Receiving Standard Of Care [Elowen-LTE]
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.
- Being tested
- Enpatoran
- Keywords
- Toll-like receptor 7, Toll-like receptor 8, WILLOW, Elowen-1, Elowen-2, Adults, Systemic lupus erythematosus, Cutaneous lupus erythematosus, Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, Acute cutaneous lupus erythematosus, Interferon-gene signature
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnpatoranDrug
Also called M5049
Participants will receive a dose of Enpatoran orally for 108 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Enpatoran | Experimental | Not described Receives: Drug: Enpatoran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Measured: From current LTE study Day 1 to Week 120
Secondary outcomes (18)
Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)
Measured: From current LTE study Day 1 to Week 120
Number of Participants With Abnormalities in Vital Signs
Measured: From current LTE study Day 1 to Week 120
Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: From current LTE study Baseline to Week 108
Percentage of Participants with BILAG Moderate to Severe Flares
Measured: 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.
Measured: From current LTE study Baseline to Week 108
Percentage of Participants With Lupus Low Disease Activity State (LLDAS) Attainment
Measured: From LTE study Day 1 to Week 108
Percentage of Participants With Sustained LLDAS
Measured: 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.
Measured: 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.
Measured: Elowen-1/Elowen-2 study Day 1, current LTE study Week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840287
- Sponsor's protocol ID
- MS504908_0002
- Other IDs
- 2026-525294-39-00
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD supporting publicly available results will be evaluated for sharing.