| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524855-30-00 | EU Trial (CTIS) Number | ||
| 169831 | Other Identifier | IND |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enpatoran | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enpatoran | Drug | Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria
For participants with SLE:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Medical Information | Contact | 888-275-7376 | eMediUSA@emdserono.com | |
| Communication Center | Contact | +49 6151 72 5200 | service@emdgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Rheumatology Clinical Trials, Inc. | Recruiting | Upland | California | 91786 | United States | |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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IPD supporting publicly available results will be evaluated for sharing.
IPD from completed trials will be publicly available within 6 months after all of the following events:
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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| Placebo | Drug | Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168. |
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| Standard of care (SoC) | Drug | Participants will receive Investigator-recommended SoC. |
|
| At Week 24 |
| Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) | From Day 1 to Week 24 |
| Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters | From Day 1 to Week 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. | At Week 24 |
| Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline | At Weeks 4 and 24 |
| Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction | 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. | 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). | 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. | 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. | 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. | 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. | At Week 24 |
| Percentage of Participants with BILAG Moderate to Severe Flares | up to Week 24 |
| Time to First Moderate/Severe BILAG Flare | Median time to first moderate or severe BILAG Flare will be calculated. | Day 1 through Week 24 |
| Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose | CS reduction is defined as of daily prednisone-equivalent dose from >= 10 milligrams per day (mg/day) at Day 1 to <= 5 mg/day and sustained for 12 weeks | Day 1 up to 24 weeks |
| Omega Research Debary, LLC |
| Recruiting |
| DeBary |
| Florida |
| 32713 |
| United States |
| GTL Medical And Research Group | Recruiting | Miami | Florida | 33173 | United States |
| Bolanos Clinical Research | Recruiting | Pembroke Pines | Florida | 33026 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Accurate Clinical Research Inc. - Lake Charles | Recruiting | Lake Charles | Louisiana | 70605 | United States |
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| North Texas Center for Clinical Research | Recruiting | Frisco | Texas | 75034 | United States |
| The Medical Arts Health Research Group - 300128547 | Recruiting | Kelowna | British Columbia | V1Y 4Z5 | Canada |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D008179 | Lupus Erythematosus, Discoid |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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