The WILLOW Study With M5049 in SLE and CLE (SCLE and/or D... | NCT05162586 | Trialant
NCT05162586
Sponsor
EMD Serono Research & Development Institute, Inc.
Status
Completed
Last Update Posted
Dec 1, 2025Actual
Enrollment
456Actual
Phase
Phase 2
Conditions
Systemic Lupus Erythematosus
Interventions
Enpatoran low dose
Enpatoran medium dose
Enpatoran high dose
Placebo
Countries
United States
Argentina
Australia
Brazil
Bulgaria
Chile
China
Colombia
Greece
Israel
Japan
Mauritius
Mexico
Moldova
Philippines
Poland
Romania
Serbia
South Africa
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT05162586
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MS200569_0003
Secondary IDs
ID
Type
Description
Link
2021-004648-27
EudraCT Number
2024-510872-18-00
EU Trial (CTIS) Number
Brief Title
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW)
Acronym
Not provided
Organization
EMD SeronoINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 31, 2022Actual
Primary Completion Date
Nov 20, 2024Actual
Completion Date
Nov 20, 2024Actual
First Submitted Date
Dec 8, 2021
First Submission Date that Met QC Criteria
Dec 8, 2021
First Posted Date
Dec 17, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Nov 17, 2025
Results First Submitted that Met QC Criteria
Nov 17, 2025
Results First Posted Date
Dec 1, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 17, 2025
Last Update Posted Date
Dec 1, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EMD Serono Research & Development Institute, Inc.INDUSTRY
Collaborators
Name
Class
Merck KGaA, Darmstadt, Germany
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.
Detailed Description
Not provided
Conditions Module
Conditions
Systemic Lupus Erythematosus
Keywords
Toll-like Receptor 7
Toll-like Receptor 8
WILLOW
Adults
SLE
CLE
Lupus
Discoid lupus erythematosus
Subacute cutaneous lupus erythematosus
M5049
Enpatoran
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
456Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: Placebo
Placebo Comparator
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.
Drug: Placebo
Cohort A: Enpatoran low dose
Experimental
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.
Drug: Enpatoran low dose
Cohort A: Enpatoran medium dose
Experimental
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.
Drug: Enpatoran medium dose
Cohort A: Enpatoran high dose
Experimental
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.
Drug: Enpatoran high dose
Cohort B (Part 1 + Part 2): Placebo
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Enpatoran low dose
Drug
Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
Cohort A: Enpatoran low dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) was a validated instrument used to assess disease activity (CLASI-A) and damage in lupus erythematosus. The activity scale included erythema, scale/hypertrophy, active alopecia, recent hair loss, and mucous membrane disease, while the damage scale measured dyspigmentation, atrophy, and scarring. CLASI-A scores ranged from 0 to 70, with mild, moderate, and severe disease corresponding to scores of 0-9, 10-20, and 21-70, respectively. Erythema and scale/hypertrophy sub-scores were computed across 13 body areas, with maximum scores of 39 and 26, respectively. The remaining 5 points reflected contributions from active alopecia (0-3), recent hair loss (0-1), and mucous membrane involvement (0-1), completing the total CLASI-A activity score. Directionality reflected worsening with higher scores and improvement with lower scores.
Baseline, week 16
Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
BILAG-based BICLA response is defined as participants meeting all of the following criteria: 1. Improvement in baseline BILAG scores in all organ systems with moderate or severe disease activity-i.e., all grade A scores (severe disease requiring high-dose therapy) must improve to B (moderate), C (mild), or D (no activity); all grade B scores (moderate disease requiring moderate therapy) must improve to C or D; 2. No new BILAG A scores and no more than one new BILAG B score; 3. No worsening in total SLEDAI-2K score from baseline; 4. No significant deterioration (≤10%) in physician's global assessment; and 5. No treatment failure, defined as initiation of non-protocol therapy. Directionality is toward clinical improvement and disease stabilization.
At Week 24
Secondary Outcomes
Measure
Description
Time Frame
Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Autoimmune or rheumatic disease other than SLE or CLE
Dermatological diseases other than cutaneous manifestations of SLE or CLE
Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
Ongoing or active clinically significant viral, bacterial, or fungal infection
History of uncontrolled seizures or other neurological disorder
History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
History of malignancy
Other protocol defined exclusion criteria could apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
EMD Serono Research & Development Institute, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Lundquist Institute at Harbor-UCLA Medical Center
Morand EF, Werth VP, Wenzel J, Furie R, Dall'Era M, Sanchez-Guerrero J, Roy S, Goodson SG, Moreau F, Guhring H, Sgouroudi E, Klopp-Schulze L, Pearson DR. Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findings from Cohort A of a multicentre, international, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Rheumatol. 2026 Jul;8(7):e513-e527. doi: 10.1016/S2665-9913(25)00337-6. Epub 2026 May 7.
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access Criteria
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.
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .
Drug: Placebo
Cohort B (Part 1 + Part 2): Enpatoran high dose
Experimental
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.
Drug: Enpatoran high dose
Cohort B (Part 2): Enpatoran low dose
Experimental
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive low dose of M5049.
Drug: Enpatoran low dose
Cohort B (Part 2): Enpatoran medium dose
Experimental
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.
Drug: Enpatoran medium dose
Cohort B (Part 2): Enpatoran low dose
M5049
Enpatoran medium dose
Drug
Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
Cohort A: Enpatoran medium dose
Cohort B (Part 2): Enpatoran medium dose
M5049
Enpatoran high dose
Drug
Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
Cohort A: Enpatoran high dose
Cohort B (Part 1 + Part 2): Enpatoran high dose
M5049
Placebo
Drug
Participants will receive placebo matched to Enpatoran up to 24 weeks.
Cohort A: Placebo
Cohort B (Part 1 + Part 2): Placebo
From screening upto safety follow up period (up to approximately 33 weeks)
Cohort A and B: Number of Participants With Abnormal Laboratory Parameters
Laboratory parameters included hematology, biochemistry, Urinalysis, Renal Toxicity and Hepatotoxicity. Number of Participants with Abnormal laboratory parameters (severity of grade greater or equal to 3) were reported. Severity of grade 3 or higher TEAEs were graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.
From screening upto safety follow up period (up to approximately 33 weeks)
Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical importance was determined by the investigator. The number of participants with clinically important increases in QTCF findings were reported.
From screening upto safety follow up period (up to approximately 33 weeks)
Cohort A and Cohort B: Change From Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Scale Score at Week 16 and Week 24
The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).
Baseline and at Week 16 and Week 24
Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24
The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). The score reflects the clinician's integrated judgment based on clinical signs, symptoms, laboratory findings, and patient-reported outcomes. PGA is used to quantify disease severity and monitor treatment response over time. Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.
Baseline and at Week 16 and Week 24
Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction
BICLA (BILAG-Based Composite Lupus Assessment) defines response as improvement in all baseline BILAG A scores to B, C, or D and all B scores to C or D, with no new A scores and no more than one new B score. Responders must also show no worsening in SLEDAI-2K or Physician's Global Assessment (defined as ≥0.3-point increase). Corticosteroid (CS) reduction is defined as a decrease in daily prednisone-equivalent dose from ≥10 mg at Day 1 to ≤5 mg by Week 12, sustained through Week 24. BILAG grades reflect disease severity: A = severe disease requiring high-dose therapy; B = moderate disease requiring moderate therapy; C = mild stable disease; D = no current activity.
At week 24 (BICLA Response) and Day 1 upto Week 24 (CS Reductions)
Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24. The number of participants with Clinically Meaningful CS Reduction were reported.
Day 1 up to Week 24
Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24
The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The number of participants with CLA-IGA score 0 or 1 at Week 16 and Week 24 were reported.
At Week 16 and Week 24
Cohort B: Number of Participants With Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
SRI-4 response was defined as >= 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
At Week 24
Cohort B: Number of Participants With Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
Lupus Low Disease Activity State (LLDAS) Attainment at Week 24 is defined as meeting all of the following criteria at the specified time point: SLE Disease Activity Index 2000 (SLEDAI-2K) ≤4 with no activity in major organ systems, no new disease activity compared to the previous assessment, Physician's Global Assessment (PGA) ≤1, current prednisone dose ≤7.5 mg/day, and standard maintenance dosing of immunosuppressive therapies. The number of participants with LLDAS Attainment at Week 24 were reported.
At Week 24
Cohort B: Number of Participants With Remission Attainment at Week 24
Remission attainment was defined as a Clinical Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index score of 0, Physician's Global Assessment of Systemic Lupus Erythematosus <0.5 (0-3 scale), daily prednisolone-equivalent dose ≤5 mg, and stable use of immunosuppressive therapies including biologics. Number of participants who attained remission was reported.
At Week 24
Cohort B: Percentage of Participants With 50% Reduction in Baseline Tender and Swollen Count at Week 24
The 28-joint count questionnaire assesses 14 joints on each side (28 joints overall) for both tenderness and swelling. The outcome for the assessment of each joint can be "absent", "present", "replaced" or "unable to evaluate".Tender 28-joint count will be derived as the count of joints which are tender. Swollen 28-joint count will be derived as the count of joints which are swollen. The number of tender and swollen joints will be calculated as the count of joints which are both tender and swollen. Percentage of Participants with 50% Reduction in Baseline Tender and Swollen Count at Week 24 was reported.
At Week 24
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare is defined as the time from baseline to the first occurrence of moderate or severe disease activity, as measured by the BILAG Index. The BILAG Index assesses clinical signs, symptoms, and laboratory parameters related to systemic lupus erythematosus (SLE) across 9 organ systems. Each organ system is scored alphabetically: A (severe disease), B (moderate disease), C (mild stable disease), D (inactive but previously active), and E (inactive and never affected). A moderate/severe flare is defined as the presence of at least one new or worsening BILAG A score (severe disease activity) or two or more new or worsening BILAG B scores (moderate disease activity) in any organ system, compared to the previous visit. Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare was estimated via Kaplan-Meier method.
Baseline (Day 1) through Week 24
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare is defined as the time from baseline to the first occurrence of a severe flare, as measured by the SLEDAI Flare Index (SFI). A severe flare is characterized by a ≥12-point increase in the SLEDAI score from the previous visit, accompanied by a ≥2.5-point increase in the physician's global assessment (on a 0-3 visual analogue scale), and a change in treatment such as initiation of corticosteroids at a dose >0.5 mg/kg/day and/or the addition of a new immunosuppressive agent. Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare was estimated via Kaplan-Meier method.
Baseline (Day 1) through Week 24
Cohort A and B: Change From Baseline in Skindex 29+3 Symptom Domain Score at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The symptoms domain includes items measuring physical sensations such as itching, burning, stinging, and pain. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
Baseline and at week 24
Cohort A and B: Change From Baseline in the Skindex 29+3 Functioning Domain Scores at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The functioning domain assesses the impact of skin disease on daily activities, social interactions, and work. Items are rated on a 5-point Likert scale (1 = "never" to 5 = "all the time") and transformed to a 0-100 scale, where higher scores reflect greater impairment in functioning.
Baseline and at Week 24
Cohort A and B: Change From Baseline in the Skindex 29+3 Emotion Domain Scores at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The emotion domain of the Skindex-29+3 assesses the psychological impact of skin disease in individuals with cutaneous lupus erythematosus. It includes items that measure feelings such as embarrassment, frustration, anger, sadness, and worry related to skin symptoms. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating greater emotional distress.
Baseline and at Week 24
Cohort A and B: Change From Baseline in the Skindex 29+3 Lupus-Specific Domain Scores at Week 24
The Skindex-29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations. It includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific to lupus. Subscale scores are generated for the 3 original domains: symptoms, functioning, and emotional well-being. For all subscales, higher scores indicate worse symptoms or lower functioning. The lupus-specific domain captures symptoms and concerns unique to cutaneous lupus, including sensitivity to sunlight, flares from environmental exposure, and emotional impact of lupus-related skin changes. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale. Higher scores reflect greater symptom burden and disease impact.
Baseline and at Week 24
Cohort A and B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item, self-reported questionnaire designed to assess fatigue and its impact on daily activities and functioning in individuals with chronic illness, including systemic lupus erythematosus. Each item is rated on a 5-point Likert-type scale ranging from 0 = "not at all" to 4 = "very much". Items are scored to ensure that 0 represents the worst and 4 the best possible outcome. The score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning.
Baseline and at Week 24
Brandon
Florida
33511
United States
Advance Medical Research Center
Miami
Florida
33135
United States
New Horizon Research Center, Inc
Miami
Florida
33165
United States
Charisma Medical and Research Center
Miami Lakes
Florida
33014
United States
HMD Research, LLC
Orlando
Florida
32819
United States
D&H Tamarac Research Center, LLC
Tamarac
Florida
33321
United States
RNA America Health Sciences
Sugar Hill
Georgia
30518
United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis
Indiana
46256
United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc
Michigan
48439
United States
University of Minnesota
Minneapolis
Minnesota
55455
United States
Across the Life Span
Smithfield
North Carolina
27577
United States
Ohio State University - CTMO Parent
Columbus
Ohio
43215
United States
Ramesh C Gupta, MD - Memphis, TN
Memphis
Tennessee
38119
United States
CINME - Centro De Investigaciones Metabolicas
Buenos Aires
Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires
Argentina
Centro Dermatologico Schejtman
Ciudad Autonoma Buenos Aires
Argentina
Hospital Militar Central Dr. Cosme Argerich
Ciudad Autonoma Buenos Aires
Argentina
Centro de Investigaciones Medicas Mar del Plata - CIM
Mar del Plata
Argentina
Instituto de Reumatologia
Mendoza
Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario
Argentina
Instituto Medico de alta Complejidad San Isidro S.A (IMAC)
San Fernando
Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan
Argentina
PSORIAHUE-Medicina Interdisciplinar
San Miguel
Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán
Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán
Argentina
Monash Medical Centre Clayton
Clayton
Australia
Westmead Hospital - SUPERSEDED
Westmead
Australia
Veracity Clinical Research
Woolloongabba
Australia
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte
Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
Cuiabá
Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba
Brazil
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza
Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora
Brazil
Hospital Bruno Born
Lajeado
Brazil
Hospital Moinhos de Vento
Porto Alegre
Brazil
Clínica SER da Bahia
Salvador
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto - CIP - Centro Integrado de Pesquisa
São José do Rio Preto
Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo
Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo
Brazil
DCC 'Sveti Georgi' EOOD - Cardiology Office
Haskovo
Bulgaria
MC Artmed OOD
Plovdiv
Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo
Bulgaria
DCC "Alexandrovska", EOOD
Sofia
Bulgaria
Military Medical Academy - MHAT - Sofia - Department of Rheumatology
Sofia
Bulgaria
UMHAT "Sv. Ivan Rilski", EAD - Clinic of Rheumatology
Sofia
Bulgaria
Clínica Alemana de Osorno
Osorno
Chile
BioMedica Research Group - Psicomedica Clinical and Research Group
Santiago
Chile
CeCim Biocinetic
Santiago
Chile
Centro Medico Prosalud
Santiago
Chile
CIEC - Centro Internacional de Estudios Clínicos - Valenzuela Y Compania Ltda
Santiago
Chile
Dermacross
Santiago
Chile
The First Affiliated Hospital of Baotou Medical College
Baotou
China
Peking Union Medical College Hospital - Beijing Union Medical College Hospital
Beijing
China
The First Hospital of Jilin University
Changchun
China
The 2nd Xiangya Hospital of Central South University
Changsha
China
West China Hospital, Sichuan University
Chengdu
China
Guangdong Provincial People's Hospital - Oncology
Guangzhou
China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
China
Hainan General Hospital
Haikou
China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
China
The Second Affiliated Hospital of Nanchang University
Nanchang
China
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing
China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing
China
Huashan Hospital, Fudan University
Shanghai
China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai
China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai
China
Shanghai Skin Disease Hospital
Shanghai
China
The First Affiliated Hospital of Soochow University
Suzhou
China
Tianjin Medical University General Hospital
Tianjin
China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
China
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla
Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
Bogotá
Colombia
Servimed S.A.S.
Bucaramanga
Colombia
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Medellín
Colombia
Healthy Medical Center
Zipaquirá
Colombia
"Andreas Syggros" Hospital - Department of Dermatology
Athens
Greece
General Hospital of Athens Laiko
Athens
Greece
University Hospital of Patra
Pátrai
Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki
Greece
General Hospital Papageorgiou
Thessaloniki
Greece
Skin and Venereal Diseases' Hospital
Thessaloniki
Greece
Chaim Sheba Medical Center - pt
Ramat Gan
Israel
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi
Japan
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
Chiba
Japan
St. Luke's International Hospital - Dept of Immunology/Allergy
Chūōku
Japan
Hiroshima University Hospital - Dept of Rheumatology/Immunology
Hiroshima
Japan
Eiraku Clinic - Dept of Rheumatology
Kagoshima
Japan
Kanazawa University Hospital - Dept of Rheumatology/Immunology
Kanazawa
Japan
Saitama Medical Center - Dept of Rheumatology/Immunology
Kawagoe-shi
Japan
Kagawa University Hospital - Dept of Immunology/ Rheumatology
Kita-gun
Japan
Toho University Ohashi Medical Center - Dept of Immunology/Rheumatology
Meguro-ku
Japan
Hokkaido University Hospital - Dept of Internal Medicine 2(Rheumatology/Immunolog
Sapporo
Japan
Tohoku University Hospital - Dept of Hematology/Immunology
Sendai
Japan
Ehime University Hospital - Dept of Immunology/Rheumatology
Toon-shi
Japan
CAP Research Ltd
Quatre Bornes
Mauritius
Consultorio Particular del Dr. Miguel Cortes Hernandez - (dentro del Centro de Especialidades Medicas Vista
Cuernavaca
Mexico
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara
Mexico
Centro Medico del Angel
Mexicali
Mexico
CAIMED Investigacion en salud S.A de C.V.
Mexico City
Mexico
Centro de Investigacion Clínica GRAMEL S.C
México
Mexico
Citer, Centro de Investigación Y Tratamiento de Las Enfermedades Reumaticas Sa de Cv
México
Mexico
Clinstile, S.A. de C.V.
México
Mexico
Consultorio de Reumatologia - Hospital Angeles Lindavista Cons. 445B
México
Mexico
Grupo Medico Camino S.C.
México
Mexico
CIMAB S.A. de C.V. - Centro de Investigacion Medica Alberto Bazzoni
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
FG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
FG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
FG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
FG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
FG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
FG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
FG00026 subjects
FG00124 subjects
FG00226 subjects
FG00326 subjects
FG00495 subjects
FG00571 subjects
FG00674 subjects
FG007114 subjects
Participants With BILAG≥1A/2B Randomized in Error Due to Systemic Disease Activity
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Cohort B Part 1
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00420 subjects
FG0050 subjects
FG0060 subjects
FG00740 subjects
Cohort B Part 2
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00474 subjects
FG00571 subjects
FG00674 subjects
FG00774 subjects
COMPLETED
FG00022 subjects
FG00123 subjects
FG00225 subjects
FG00324 subjects
FG00479 subjects
FG00564 subjects
FG00665 subjects
FG007104 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG00416 subjects
FG0057 subjects
FG0069 subjects
FG00710 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
The Full Analysis Set (FAS) included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
BG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
BG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
BG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
BG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
BG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
BG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
BG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00123
BG00225
BG00326
BG00494
BG00571
BG00674
BG007114
BG008453
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049± 11.0
BG00142± 12.1
BG00247± 14.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00117
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG0019
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) was a validated instrument used to assess disease activity (CLASI-A) and damage in lupus erythematosus. The activity scale included erythema, scale/hypertrophy, active alopecia, recent hair loss, and mucous membrane disease, while the damage scale measured dyspigmentation, atrophy, and scarring. CLASI-A scores ranged from 0 to 70, with mild, moderate, and severe disease corresponding to scores of 0-9, 10-20, and 21-70, respectively. Erythema and scale/hypertrophy sub-scores were computed across 13 body areas, with maximum scores of 39 and 26, respectively. The remaining 5 points reflected contributions from active alopecia (0-3), recent hair loss (0-1), and mucous membrane involvement (0-1), completing the total CLASI-A activity score. Directionality reflected worsening with higher scores and improvement with lower scores.
The Full Analysis Set (FAS) included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. "Overall number of participants analyzed" refers to those evaluable for the outcome measure,
Posted
Mean
Standard Deviation
scores on a scale
Baseline, week 16
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
Units
Counts
Participants
OG00023
OG00122
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.0± 3.94
OG001-9.0± 4.60
OG002-10.2± 6.77
OG003
Primary
Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
BILAG-based BICLA response is defined as participants meeting all of the following criteria: 1. Improvement in baseline BILAG scores in all organ systems with moderate or severe disease activity-i.e., all grade A scores (severe disease requiring high-dose therapy) must improve to B (moderate), C (mild), or D (no activity); all grade B scores (moderate disease requiring moderate therapy) must improve to C or D; 2. No new BILAG A scores and no more than one new BILAG B score; 3. No worsening in total SLEDAI-2K score from baseline; 4. No significant deterioration (≤10%) in physician's global assessment; and 5. No treatment failure, defined as initiation of non-protocol therapy. Directionality is toward clinical improvement and disease stabilization.
The Full Analysis Set (FAS) included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Secondary
Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
From screening upto safety follow up period (up to approximately 33 weeks)
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Number of Participants With Abnormal Laboratory Parameters
Laboratory parameters included hematology, biochemistry, Urinalysis, Renal Toxicity and Hepatotoxicity. Number of Participants with Abnormal laboratory parameters (severity of grade greater or equal to 3) were reported. Severity of grade 3 or higher TEAEs were graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.
The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
From screening upto safety follow up period (up to approximately 33 weeks)
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical importance was determined by the investigator. The number of participants with clinically important increases in QTCF findings were reported.
The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.
Posted
Count of Participants
Participants
From screening upto safety follow up period (up to approximately 33 weeks)
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and Cohort B: Change From Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Scale Score at Week 16 and Week 24
The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).
The FAS included all participants randomized in the cohort to which they were eligible. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. Participants who were randomized in error were excluded from FAS.
Posted
Mean
Standard Deviation
units on a scale
Baseline and at Week 16 and Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Secondary
Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24
The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). The score reflects the clinician's integrated judgment based on clinical signs, symptoms, laboratory findings, and patient-reported outcomes. PGA is used to quantify disease severity and monitor treatment response over time. Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.
The FAS included all participants randomized in the cohort to which they were eligible. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. Participants who were randomized in error were excluded from FAS.
Posted
Mean
Standard Deviation
millimeter
Baseline and at Week 16 and Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Secondary
Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction
BICLA (BILAG-Based Composite Lupus Assessment) defines response as improvement in all baseline BILAG A scores to B, C, or D and all B scores to C or D, with no new A scores and no more than one new B score. Responders must also show no worsening in SLEDAI-2K or Physician's Global Assessment (defined as ≥0.3-point increase). Corticosteroid (CS) reduction is defined as a decrease in daily prednisone-equivalent dose from ≥10 mg at Day 1 to ≤5 mg by Week 12, sustained through Week 24. BILAG grades reflect disease severity: A = severe disease requiring high-dose therapy; B = moderate disease requiring moderate therapy; C = mild stable disease; D = no current activity.
The FAS included all participants randomized in the cohort to which they were eligible. "Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At week 24 (BICLA Response) and Day 1 upto Week 24 (CS Reductions)
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Secondary
Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction
CS reduction is defined as the reduction of daily prednisone-equivalent dose from >= 10 mg at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24. The number of participants with Clinically Meaningful CS Reduction were reported.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. "Overall number of participants analyzed" refers to those evaluable for the outcome measure.
Posted
Count of Participants
Participants
Day 1 up to Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
Secondary
Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24
The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The number of participants with CLA-IGA score 0 or 1 at Week 16 and Week 24 were reported.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At Week 16 and Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
Secondary
Cohort B: Number of Participants With Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
SRI-4 response was defined as >= 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Secondary
Cohort B: Number of Participants With Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
Lupus Low Disease Activity State (LLDAS) Attainment at Week 24 is defined as meeting all of the following criteria at the specified time point: SLE Disease Activity Index 2000 (SLEDAI-2K) ≤4 with no activity in major organ systems, no new disease activity compared to the previous assessment, Physician's Global Assessment (PGA) ≤1, current prednisone dose ≤7.5 mg/day, and standard maintenance dosing of immunosuppressive therapies. The number of participants with LLDAS Attainment at Week 24 were reported.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
Secondary
Cohort B: Number of Participants With Remission Attainment at Week 24
Remission attainment was defined as a Clinical Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index score of 0, Physician's Global Assessment of Systemic Lupus Erythematosus <0.5 (0-3 scale), daily prednisolone-equivalent dose ≤5 mg, and stable use of immunosuppressive therapies including biologics. Number of participants who attained remission was reported.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Count of Participants
Participants
At Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
Secondary
Cohort B: Percentage of Participants With 50% Reduction in Baseline Tender and Swollen Count at Week 24
The 28-joint count questionnaire assesses 14 joints on each side (28 joints overall) for both tenderness and swelling. The outcome for the assessment of each joint can be "absent", "present", "replaced" or "unable to evaluate".Tender 28-joint count will be derived as the count of joints which are tender. Swollen 28-joint count will be derived as the count of joints which are swollen. The number of tender and swollen joints will be calculated as the count of joints which are both tender and swollen. Percentage of Participants with 50% Reduction in Baseline Tender and Swollen Count at Week 24 was reported.
The FAS included all participants randomized in the cohort to which they were eligible. "Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Number
percentage of participants
At Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Cohort B (Part 2): Enpatoran 25 mg
Secondary
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare is defined as the time from baseline to the first occurrence of moderate or severe disease activity, as measured by the BILAG Index. The BILAG Index assesses clinical signs, symptoms, and laboratory parameters related to systemic lupus erythematosus (SLE) across 9 organ systems. Each organ system is scored alphabetically: A (severe disease), B (moderate disease), C (mild stable disease), D (inactive but previously active), and E (inactive and never affected). A moderate/severe flare is defined as the presence of at least one new or worsening BILAG A score (severe disease activity) or two or more new or worsening BILAG B scores (moderate disease activity) in any organ system, compared to the previous visit. Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare was estimated via Kaplan-Meier method.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Median
95% Confidence Interval
days
Baseline (Day 1) through Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Secondary
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare is defined as the time from baseline to the first occurrence of a severe flare, as measured by the SLEDAI Flare Index (SFI). A severe flare is characterized by a ≥12-point increase in the SLEDAI score from the previous visit, accompanied by a ≥2.5-point increase in the physician's global assessment (on a 0-3 visual analogue scale), and a change in treatment such as initiation of corticosteroids at a dose >0.5 mg/kg/day and/or the addition of a new immunosuppressive agent. Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare was estimated via Kaplan-Meier method.
The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.
Posted
Median
95% Confidence Interval
days
Baseline (Day 1) through Week 24
ID
Title
Description
OG000
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG001
Cohort B (Part 2): Enpatoran 25 mg
Secondary
Cohort A and B: Change From Baseline in Skindex 29+3 Symptom Domain Score at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The symptoms domain includes items measuring physical sensations such as itching, burning, stinging, and pain. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
The FAS included all participants randomized in the cohort to which they were eligible."Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and at week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Change From Baseline in the Skindex 29+3 Functioning Domain Scores at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The functioning domain assesses the impact of skin disease on daily activities, social interactions, and work. Items are rated on a 5-point Likert scale (1 = "never" to 5 = "all the time") and transformed to a 0-100 scale, where higher scores reflect greater impairment in functioning.
The FAS included all participants randomized in the cohort to which they were eligible."Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and at Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Change From Baseline in the Skindex 29+3 Emotion Domain Scores at Week 24
The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The emotion domain of the Skindex-29+3 assesses the psychological impact of skin disease in individuals with cutaneous lupus erythematosus. It includes items that measure feelings such as embarrassment, frustration, anger, sadness, and worry related to skin symptoms. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating greater emotional distress.
The FAS included all participants randomized in the cohort to which they were eligible."Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and at Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Change From Baseline in the Skindex 29+3 Lupus-Specific Domain Scores at Week 24
The Skindex-29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations. It includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific to lupus. Subscale scores are generated for the 3 original domains: symptoms, functioning, and emotional well-being. For all subscales, higher scores indicate worse symptoms or lower functioning. The lupus-specific domain captures symptoms and concerns unique to cutaneous lupus, including sensitivity to sunlight, flares from environmental exposure, and emotional impact of lupus-related skin changes. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale. Higher scores reflect greater symptom burden and disease impact.
The FAS included all participants randomized in the cohort to which they were eligible."Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and at Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
Secondary
Cohort A and B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item, self-reported questionnaire designed to assess fatigue and its impact on daily activities and functioning in individuals with chronic illness, including systemic lupus erythematosus. Each item is rated on a 5-point Likert-type scale ranging from 0 = "not at all" to 4 = "very much". Items are scored to ensure that 0 represents the worst and 4 the best possible outcome. The score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning.
The FAS included all participants randomized in the cohort to which they were eligible."Overall number of participants analyzed" refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
scores on a scale
Baseline and at Week 24
ID
Title
Description
OG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
OG001
Cohort A: Enpatoran 25 mg
Time Frame
From screening up to safety follow up period (up to approximately 33 weeks)
Description
Participants were included in the treatment group in which they actually received study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A: Placebo
Participants with cutaneous lupus erythematosus (CLE) (active subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) or systemic lupus erythematosus (SLE) with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) were enrolled in Cohort A to receive placebo matched to Enpatoran twice daily for 24 weeks.
0
26
1
26
8
26
EG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
0
24
2
24
4
24
EG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
0
26
0
26
6
26
EG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
0
26
1
26
13
26
EG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
0
95
3
95
29
95
EG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
0
71
1
71
17
71
EG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
0
74
3
74
24
74
EG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
0
114
5
114
33
114
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Herpes zoster
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG0031 affected26 at risk
EG0040 affected95 at risk
EG0050 affected71 at risk
EG0060 affected74 at risk
EG0070 affected114 at risk
Humerus fracture
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0011 affected24 at risk
EG0020 affected26 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0011 affected24 at risk
EG0020 affected26 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0011 affected24 at risk
EG0020 affected26 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 27.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Peripheral nerve injury
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Device dislocation
Product Issues
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Vein rupture
Vascular disorders
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0022 affected26 at risk
EG0032 affected26 at risk
EG0047 affected95 at risk
EG0054 affected71 at risk
EG0060 affected74 at risk
EG0070 affected114 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0012 affected24 at risk
EG0024 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0004 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Influenza
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA version 27.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0012 affected24 at risk
EG0022 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 27.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Weight increased
Investigations
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0022 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 27.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected26 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Communication Center
Merck Healthcare KGaA, DarmstadtGermany, an affiliate of Merck KGaA,Darmstadt, Germany
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00095
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG00037
OG00141
OG00236
OG00356
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00124
OG00226
OG00326
OG00495
OG00571
OG00674
OG007114
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00012
OG00115
OG00215
OG00321
OG00461
OG00542
OG00647
OG00770
Serious TEAEs
Title
Measurements
OG0001
OG0012
OG0020
OG003
AESI
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00124
OG00226
OG00326
OG00495
OG00571
OG00674
OG007114
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00124
OG00226
OG00326
OG00495
OG00571
OG00674
OG007114
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00123
OG00225
OG00326
OG00441
OG00529
OG00638
OG00754
Title
Denominators
Categories
Baseline
ParticipantsOG00026
ParticipantsOG00123
ParticipantsOG00225
ParticipantsOG00326
ParticipantsOG00441
ParticipantsOG00529
ParticipantsOG00638
ParticipantsOG00754
Title
Measurements
OG0003.0± 0.66
OG0013.0± 0.714
OG0023.0± 0.61
OG003
Week 16
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00224
ParticipantsOG00325
Week 24
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00324
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00123
OG00225
OG00325
OG00439
OG00528
OG00635
OG00750
Title
Denominators
Categories
Baseline
ParticipantsOG00026
ParticipantsOG00123
ParticipantsOG00225
ParticipantsOG00325
ParticipantsOG00439
ParticipantsOG00528
ParticipantsOG00635
ParticipantsOG00750
Title
Measurements
OG00061.4± 14.08
OG00161.8± 15.37
OG00256.3± 19.42
OG003
Week 16
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00324
Week 24
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00323
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00051
OG00134
OG00236
OG00359
Title
Denominators
Categories
Title
Measurements
OG00016
OG00120
OG00220
OG00328
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00026
OG00123
OG00225
OG00326
OG00451
OG00534
OG00636
OG00759
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG00212
OG0039
OG00436
OG00528
OG00627
OG00741
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
Units
Counts
Participants
OG00026
OG00123
OG00225
OG00326
Title
Denominators
Categories
Week 16
Title
Measurements
OG0004
OG00110
OG00210
OG00312
Week 24
Title
Measurements
OG0007
OG00111
OG00212
OG003
OG001
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00094
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG00050
OG00144
OG00248
OG00377
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00094
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG00023
OG00121
OG00232
OG00335
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00094
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG00010
OG0017
OG0028
OG00320
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00065
OG00146
OG00254
OG00379
Title
Denominators
Categories
Title
Measurements
OG00068.8
OG00172.2
OG00277.6
OG00379.1
OG001
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00094
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG001NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG002NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG003NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG002
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00094
OG00171
OG00274
OG003114
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG001NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG002NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG003NA(NA to NA)The number of events was insufficient to calculate the median and its associated 95% confidence intervals.
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00019
OG00121
OG00220
OG00324
OG00426
OG00519
OG00627
OG00734
Title
Denominators
Categories
Title
Measurements
OG000-13.7(-21.4 to -6.1)
OG001-27.3(-34.7 to -19.9)
OG002-28.6(-36.1 to -21.2)
OG003-21.9(-28.8 to -14.9)
OG004-9.2(-16.5 to -2.0)
OG005-17.5(-25.9 to -9.2)
OG006-15.2(-22.6 to -7.9)
OG007-17.0(-23.5 to -10.5)
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00019
OG00121
OG00220
OG00324
OG00426
OG00518
OG00627
OG00734
Title
Denominators
Categories
Title
Measurements
OG000-12.2(-19.5 to -4.8)
OG001-17.9(-24.9 to -10.8)
OG002-20.3(-27.4 to -13.1)
OG003-15.1(-21.7 to -8.5)
OG004-11.1(-18.4 to -3.8)
OG005-14.2(-23.0 to -5.5)
OG006-11.3(-18.7 to -3.8)
OG007-15.4(-22.0 to -8.9)
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00019
OG00121
OG00220
OG00324
OG00426
OG00518
OG00627
OG00734
Title
Denominators
Categories
Title
Measurements
OG000-15.8(-25.3 to -6.4)
OG001-23.1(-32.3 to -13.9)
OG002-21.2(-30.5 to -12.0)
OG003-23.2(-31.8 to -14.5)
OG004-15.3(-24.6 to -6.0)
OG005-18.0(-29.1 to -6.8)
OG006-16.9(-26.3 to -7.4)
OG007-16.3(-24.6 to -7.9)
OG001
Cohort A: Enpatoran 25 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
Units
Counts
Participants
OG00018
OG00121
OG00220
OG00324
OG00426
OG00518
OG00627
OG00734
Title
Denominators
Categories
Title
Measurements
OG000-15.5(-26.8 to -4.3)
OG001-19.9(-30.6 to -9.1)
OG002-21.1(-31.9 to -10.3)
OG003-11.0(-21.1 to -1.0)
OG004-16.4(-26.8 to -6.0)
OG005-10.9(-23.1 to 1.3)
OG006-13.1(-23.8 to -2.4)
OG007-14.5(-23.8 to -5.2)
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 25 milligrams (mg) of Enpatoran twice daily for 24 weeks.
OG002
Cohort A: Enpatoran 50 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG003
Cohort A: Enpatoran 100 mg
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) were enrolled in Cohort A to receive 100 mg of Enpatoran twice daily for 24 weeks.
OG004
Cohort B (Part 1 + Part 2): Placebo
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 were enrolled in Cohort B to receive placebo matched to Enpatoran twice daily for 24 weeks during Part 1 and Part 2.
OG005
Cohort B (Part 2): Enpatoran 25 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 25 mg of Enpatoran twice daily for 24 weeks.
OG006
Cohort B (Part 2): Enpatoran 50 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 50 mg of Enpatoran twice daily for 24 weeks.
OG007
Cohort B (Part 1 + Part 2): Enpatoran 100 mg
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 were enrolled in Cohort B to receive 100mg of Enpatoran twice daily for 24 weeks during Part 1 and Part 2.