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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
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.
Revival Research Institute, LLC
Troy, Michigan, United States
RECRUITINGArthritis and Rheumatology Research Institute PLLC
Allen, Texas, United States
RECRUITINGPercentage 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.