A Phase 3 interventional study of Enpatoran and Placebo in Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), sponsored by EMD Serono Research & Development Institute, Inc.. Recruiting at 74 sites in 20 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by EMD Serono Research & Development Institute, Inc. (part of Merck KGaA, Darmstadt, Germany) · Phase 3, Interventional, and Treatment
Australia, Brazil, Belgium, China, Thailand, United Kingdom
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. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.
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 202 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.
For participants with SLE:
Exclusion Criteria
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Enpatoran · Drug: Standard of care (SoC)
Drug: Placebo · Drug: Standard of care (SoC)
Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
Also known as: M5049
Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Participants will receive Investigator-recommended SoC.
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 Baseline
Time frame: At Week 24
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: At Week 24
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Time frame: From Day 1 to Week 24
Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters
Time frame: From Day 1 to Week 24
Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline
Time frame: At Weeks 4 and 24
Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24
CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, 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: At Week 24
Percentage of Participants With BICLA Response and Clinically Meaningful Corticosteroid (CS) Reduction
BICLA Response and clinically meaningful CS reduction, is defined as reduction of daily prednisone-equivalent dose from \>= 10 milligrams (mg) at Day 1 to \<= 5 mg by the Week 12 visit and sustained through Week 24.
Time frame: Day 1 up to Week 12 and thereafter upto Week 24
Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24
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 of 0 (no itch) to 10 (worst imaginable itch).
Time frame: Baseline and at Week 24
Change from Baseline in CLASI-A Erythema at Week 24
CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, 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: Baseline and at Week 24
Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24
CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, 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: Baseline and at Week 24
Change from Baseline in CLASI-A Alopecia at Week 24
CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, 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: Baseline and at Week 24
Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24
The CLA-IGA-R is assessed by the investigator, who assigns rater to assign scores to 3 individual domains (e.g. erythema, other morphologic characteristics - OMC \[scales, edema)/infiltration and secondary change (vesicles, erosion, crusting)\] and follicular activity). Clinicians assess the severity of the first 2 domains of erythema and OMC from 0 (Clear) to 4 (Severe); they assess the severity of the third domain of follicular activity as "absent" or "present." Higher scores indicate more disease activity.
Time frame: At Week 24
Percentage of Participants with BILAG Moderate to Severe Flares
Time frame: up to Week 24
Time to First Moderate/Severe BILAG Flare
Median time to first moderate or severe BILAG Flare will be calculated.
Time frame: Day 1 up to 24 weeks
Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose
CS reduction is defined as reduction of daily prednisone-equivalent dose from \>= 10 milligrams per day (mg/day) at Day 1 to \<= 5 mg/day by the Week 12 visit and sustained through Week 24.
Time frame: Day 1 up to 24 weeks
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 Mar 2026 (actual). Primary completion is estimated for May 2029, 38 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 38 months is below that.
How these figures are worked out, and which studies are left out of them.
Australia, Brazil, Belgium, China, Thailand, United Kingdom
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
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