Trial Outcomes & Findings for The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW) (NCT NCT05162586)

NCT ID: NCT05162586

Last Updated: 2025-12-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 456 participants
• Primary outcome timeframe: Baseline, week 16
• Results posted on: 2025-12-01

Participant Flow

Participant milestones

Measure	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	26	24	26	26	95	71	74	114
Overall Study Participants With BILAG≥1A/2B Randomized in Error Due to Systemic Disease Activity	0	1	1	0	1	0	0	0
Overall Study Cohort B Part 1	0	0	0	0	20	0	0	40
Overall Study Cohort B Part 2	0	0	0	0	74	71	74	74
Overall Study COMPLETED	22	23	25	24	79	64	65	104
Overall Study NOT COMPLETED	4	1	1	2	16	7	9	10

Reasons for withdrawal

Measure	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study Other	0	0	0	0	1	0	2	2
Overall Study Lack of Efficacy	0	0	0	0	1	0	0	1
Overall Study Lost to Follow-up	0	0	0	0	2	0	0	2
Overall Study Non-Compliance	0	1	0	0	1	0	0	1
Overall Study Withdrawal by Subject	2	0	0	0	7	6	2	2
Overall Study Adverse Event	2	0	1	2	4	1	5	2

Baseline Characteristics

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Baseline characteristics by cohort

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=23 Participants 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.	Cohort A: Enpatoran 50 mg n=25 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=94 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 Participants 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.	Total n=453 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 11.0 • n=121 Participants	42 years STANDARD_DEVIATION 12.1 • n=122 Participants	47 years STANDARD_DEVIATION 14.6 • n=243 Participants	45 years STANDARD_DEVIATION 14.3 • n=24 Participants	42 years STANDARD_DEVIATION 12.3 • n=8 Participants	42 years STANDARD_DEVIATION 12.4 • n=40 Participants	39 years STANDARD_DEVIATION 12.3 • n=12 Participants	44 years STANDARD_DEVIATION 12.2 • n=53 Participants	42 years STANDARD_DEVIATION 12.3 • n=13 Participants
Sex: Female, Male Female	22 Participants n=121 Participants	17 Participants n=122 Participants	19 Participants n=243 Participants	19 Participants n=24 Participants	87 Participants n=8 Participants	69 Participants n=40 Participants	69 Participants n=12 Participants	110 Participants n=53 Participants	412 Participants n=13 Participants
Sex: Female, Male Male	4 Participants n=121 Participants	6 Participants n=122 Participants	6 Participants n=243 Participants	7 Participants n=24 Participants	7 Participants n=8 Participants	2 Participants n=40 Participants	5 Participants n=12 Participants	4 Participants n=53 Participants	41 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=121 Participants	9 Participants n=122 Participants	11 Participants n=243 Participants	11 Participants n=24 Participants	47 Participants n=8 Participants	37 Participants n=40 Participants	37 Participants n=12 Participants	51 Participants n=53 Participants	213 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=121 Participants	14 Participants n=122 Participants	14 Participants n=243 Participants	15 Participants n=24 Participants	47 Participants n=8 Participants	34 Participants n=40 Participants	37 Participants n=12 Participants	63 Participants n=53 Participants	240 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants	0 Participants n=8 Participants	0 Participants n=40 Participants	0 Participants n=12 Participants	0 Participants n=53 Participants	0 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=121 Participants	3 Participants n=122 Participants	2 Participants n=243 Participants	3 Participants n=24 Participants	27 Participants n=8 Participants	22 Participants n=40 Participants	18 Participants n=12 Participants	28 Participants n=53 Participants	107 Participants n=13 Participants
Race (NIH/OMB) Asian	7 Participants n=121 Participants	8 Participants n=122 Participants	9 Participants n=243 Participants	8 Participants n=24 Participants	26 Participants n=8 Participants	16 Participants n=40 Participants	20 Participants n=12 Participants	27 Participants n=53 Participants	121 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants	0 Participants n=8 Participants	0 Participants n=40 Participants	0 Participants n=12 Participants	0 Participants n=53 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	4 Participants n=121 Participants	1 Participants n=122 Participants	2 Participants n=243 Participants	1 Participants n=24 Participants	3 Participants n=8 Participants	6 Participants n=40 Participants	6 Participants n=12 Participants	3 Participants n=53 Participants	26 Participants n=13 Participants
Race (NIH/OMB) White	11 Participants n=121 Participants	11 Participants n=122 Participants	12 Participants n=243 Participants	14 Participants n=24 Participants	35 Participants n=8 Participants	24 Participants n=40 Participants	29 Participants n=12 Participants	51 Participants n=53 Participants	187 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants	1 Participants n=8 Participants	0 Participants n=40 Participants	0 Participants n=12 Participants	2 Participants n=53 Participants	3 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants	0 Participants n=24 Participants	2 Participants n=8 Participants	3 Participants n=40 Participants	1 Participants n=12 Participants	3 Participants n=53 Participants	9 Participants n=13 Participants

PRIMARY outcome

Timeframe: Baseline, week 16

Population: 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,

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.

Outcome measures

Measure	Cohort A: Placebo n=23 Participants 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.	Cohort A: Enpatoran 25 mg n=22 Participants 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.	Cohort A: Enpatoran 50 mg n=24 Participants 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.	Cohort A: Enpatoran 100 mg n=25 Participants 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.	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.	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.	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.	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.
Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16	-5.0 scores on a scale Standard Deviation 3.94	-9.0 scores on a scale Standard Deviation 4.60	-10.2 scores on a scale Standard Deviation 6.77	-9.7 scores on a scale Standard Deviation 5.84	—	—	—	—

PRIMARY outcome

Timeframe: At Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=95 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24	37 Participants	41 Participants	36 Participants	56 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From screening upto safety follow up period (up to approximately 33 weeks)

Population: The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=24 Participants 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.	Cohort A: Enpatoran 50 mg n=26 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=95 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 Participants 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.
Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest AESI	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	1 Participants	0 Participants	3 Participants
Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest TEAEs	12 Participants	15 Participants	15 Participants	21 Participants	61 Participants	42 Participants	47 Participants	70 Participants
Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest Serious TEAEs	1 Participants	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: From screening upto safety follow up period (up to approximately 33 weeks)

Population: The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=24 Participants 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.	Cohort A: Enpatoran 50 mg n=26 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=95 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 Participants 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.
Cohort A and B: Number of Participants With Abnormal Laboratory Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening upto safety follow up period (up to approximately 33 weeks)

Population: The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=24 Participants 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.	Cohort A: Enpatoran 50 mg n=26 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=95 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 Participants 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.
Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and at Week 16 and Week 24

Population: 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.

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).

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=23 Participants 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.	Cohort A: Enpatoran 50 mg n=25 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=41 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=29 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=38 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=54 Participants 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.
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 Week 24	-0.9 units on a scale Standard Deviation 1.17	-1.8 units on a scale Standard Deviation 0.92	-1.7 units on a scale Standard Deviation 0.92	-2.1 units on a scale Standard Deviation 1.08	-0.8 units on a scale Standard Deviation 1.00	-1.5 units on a scale Standard Deviation 1.19	-1.4 units on a scale Standard Deviation 0.94	-1.8 units on a scale Standard Deviation 0.98
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 Baseline	3.0 units on a scale Standard Deviation 0.66	3.0 units on a scale Standard Deviation 0.714	3.0 units on a scale Standard Deviation 0.61	3.179 units on a scale Standard Deviation 0.59	2.8 units on a scale Standard Deviation 0.72	2.9 units on a scale Standard Deviation 0.67	2.7 units on a scale Standard Deviation 0.65	2.8 units on a scale Standard Deviation 0.57
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 Week 16	-0.9 units on a scale Standard Deviation 1.01	-1.7 units on a scale Standard Deviation 1.09	-1.5 units on a scale Standard Deviation 1.14	-1.8 units on a scale Standard Deviation 0.88	-0.6 units on a scale Standard Deviation 0.96	-1.1 units on a scale Standard Deviation 1.15	-1.2 units on a scale Standard Deviation 1.01	-1.5 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline and at Week 16 and Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=23 Participants 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.	Cohort A: Enpatoran 50 mg n=25 Participants 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.	Cohort A: Enpatoran 100 mg n=25 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=39 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=28 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=35 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=50 Participants 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.
Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 Baseline	61.4 millimeter Standard Deviation 14.08	61.8 millimeter Standard Deviation 15.37	56.3 millimeter Standard Deviation 19.42	61.7 millimeter Standard Deviation 18.04	55.7 millimeter Standard Deviation 17.08	56.1 millimeter Standard Deviation 15.65	56.7 millimeter Standard Deviation 14.85	57.4 millimeter Standard Deviation 17.42
Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 Week 16	-25.3 millimeter Standard Deviation 20.55	-42.5 millimeter Standard Deviation 23.67	-35.2 millimeter Standard Deviation 25.70	-42.0 millimeter Standard Deviation 22.94	-16.7 millimeter Standard Deviation 20.01	-26.1 millimeter Standard Deviation 17.62	-30.7 millimeter Standard Deviation 22.78	-36.0 millimeter Standard Deviation 22.08
Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 Week 24	-23.9 millimeter Standard Deviation 25.45	-44.0 millimeter Standard Deviation 21.97	-41.2 millimeter Standard Deviation 25.12	-49.1 millimeter Standard Deviation 22.44	-21.3 millimeter Standard Deviation 18.35	-33.0 millimeter Standard Deviation 19.68	-34.8 millimeter Standard Deviation 20.06	-39.1 millimeter Standard Deviation 23.16

SECONDARY outcome

Timeframe: At week 24 (BICLA Response) and Day 1 upto Week 24 (CS Reductions)

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=51 Participants 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.	Cohort A: Enpatoran 25 mg n=34 Participants 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.	Cohort A: Enpatoran 50 mg n=36 Participants 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.	Cohort A: Enpatoran 100 mg n=59 Participants 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.	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.	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.	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.	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.
Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction	16 Participants	20 Participants	20 Participants	28 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=23 Participants 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.	Cohort A: Enpatoran 50 mg n=25 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=51 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=34 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=36 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=59 Participants 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.
Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction	6 Participants	7 Participants	12 Participants	9 Participants	36 Participants	28 Participants	27 Participants	41 Participants

SECONDARY outcome

Timeframe: At Week 16 and Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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.

Outcome measures

Measure	Cohort A: Placebo n=26 Participants 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.	Cohort A: Enpatoran 25 mg n=23 Participants 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.	Cohort A: Enpatoran 50 mg n=25 Participants 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.	Cohort A: Enpatoran 100 mg n=26 Participants 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.	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.	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.	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.	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.
Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24 Week 24	7 Participants	11 Participants	12 Participants	14 Participants	—	—	—	—
Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24 Week 16	4 Participants	10 Participants	10 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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).

Outcome measures

Measure	Cohort A: Placebo n=94 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Number of Participants With Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24	50 Participants	44 Participants	48 Participants	77 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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.

Outcome measures

Measure	Cohort A: Placebo n=94 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Number of Participants With Lupus Low Disease Activity State (LLDAS) Attainment at Week 24	23 Participants	21 Participants	32 Participants	35 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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.

Outcome measures

Measure	Cohort A: Placebo n=94 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Number of Participants With Remission Attainment at Week 24	10 Participants	7 Participants	8 Participants	20 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=65 Participants 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.	Cohort A: Enpatoran 25 mg n=46 Participants 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.	Cohort A: Enpatoran 50 mg n=54 Participants 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.	Cohort A: Enpatoran 100 mg n=79 Participants 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.	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.	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.	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.	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.
Cohort B: Percentage of Participants With 50% Reduction in Baseline Tender and Swollen Count at Week 24	68.8 percentage of participants	72.2 percentage of participants	77.6 percentage of participants	79.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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.

Outcome measures

Measure	Cohort A: Placebo n=94 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 24

Population: The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS.

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.

Outcome measures

Measure	Cohort A: Placebo n=94 Participants 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.	Cohort A: Enpatoran 25 mg n=71 Participants 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.	Cohort A: Enpatoran 50 mg n=74 Participants 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.	Cohort A: Enpatoran 100 mg n=114 Participants 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.	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.	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.	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.	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.
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	NA days The number of events was insufficient to calculate the median and its associated 95% confidence intervals.	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and at week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=19 Participants 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.	Cohort A: Enpatoran 25 mg n=21 Participants 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.	Cohort A: Enpatoran 50 mg n=20 Participants 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.	Cohort A: Enpatoran 100 mg n=24 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=26 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=19 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=27 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=34 Participants 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.
Cohort A and B: Change From Baseline in Skindex 29+3 Symptom Domain Score at Week 24	-13.7 scores on a scale Interval -21.4 to -6.1	-27.3 scores on a scale Interval -34.7 to -19.9	-28.6 scores on a scale Interval -36.1 to -21.2	-21.9 scores on a scale Interval -28.8 to -14.9	-9.2 scores on a scale Interval -16.5 to -2.0	-17.5 scores on a scale Interval -25.9 to -9.2	-15.2 scores on a scale Interval -22.6 to -7.9	-17.0 scores on a scale Interval -23.5 to -10.5

SECONDARY outcome

Timeframe: Baseline and at Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=19 Participants 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.	Cohort A: Enpatoran 25 mg n=21 Participants 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.	Cohort A: Enpatoran 50 mg n=20 Participants 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.	Cohort A: Enpatoran 100 mg n=24 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=26 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=18 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=27 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=34 Participants 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.
Cohort A and B: Change From Baseline in the Skindex 29+3 Functioning Domain Scores at Week 24	-12.2 scores on a scale Interval -19.5 to -4.8	-17.9 scores on a scale Interval -24.9 to -10.8	-20.3 scores on a scale Interval -27.4 to -13.1	-15.1 scores on a scale Interval -21.7 to -8.5	-11.1 scores on a scale Interval -18.4 to -3.8	-14.2 scores on a scale Interval -23.0 to -5.5	-11.3 scores on a scale Interval -18.7 to -3.8	-15.4 scores on a scale Interval -22.0 to -8.9

SECONDARY outcome

Timeframe: Baseline and at Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=19 Participants 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.	Cohort A: Enpatoran 25 mg n=21 Participants 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.	Cohort A: Enpatoran 50 mg n=20 Participants 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.	Cohort A: Enpatoran 100 mg n=24 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=26 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=18 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=27 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=34 Participants 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.
Cohort A and B: Change From Baseline in the Skindex 29+3 Emotion Domain Scores at Week 24	-15.8 scores on a scale Interval -25.3 to -6.4	-23.1 scores on a scale Interval -32.3 to -13.9	-21.2 scores on a scale Interval -30.5 to -12.0	-23.2 scores on a scale Interval -31.8 to -14.5	-15.3 scores on a scale Interval -24.6 to -6.0	-18.0 scores on a scale Interval -29.1 to -6.8	-16.9 scores on a scale Interval -26.3 to -7.4	-16.3 scores on a scale Interval -24.6 to -7.9

SECONDARY outcome

Timeframe: Baseline and at Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=18 Participants 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.	Cohort A: Enpatoran 25 mg n=21 Participants 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.	Cohort A: Enpatoran 50 mg n=20 Participants 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.	Cohort A: Enpatoran 100 mg n=24 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=26 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=18 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=27 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=34 Participants 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.
Cohort A and B: Change From Baseline in the Skindex 29+3 Lupus-Specific Domain Scores at Week 24	-15.5 scores on a scale Interval -26.8 to -4.3	-19.9 scores on a scale Interval -30.6 to -9.1	-21.1 scores on a scale Interval -31.9 to -10.3	-11.0 scores on a scale Interval -21.1 to -1.0	-16.4 scores on a scale Interval -26.8 to -6.0	-10.9 scores on a scale Interval -23.1 to 1.3	-13.1 scores on a scale Interval -23.8 to -2.4	-14.5 scores on a scale Interval -23.8 to -5.2

SECONDARY outcome

Timeframe: Baseline and at Week 24

Population: 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.

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.

Outcome measures

Measure	Cohort A: Placebo n=19 Participants 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.	Cohort A: Enpatoran 25 mg n=21 Participants 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.	Cohort A: Enpatoran 50 mg n=20 Participants 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.	Cohort A: Enpatoran 100 mg n=23 Participants 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.	Cohort B (Part 1 + Part 2): Placebo n=79 Participants 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.	Cohort B (Part 2): Enpatoran 25 mg n=63 Participants 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.	Cohort B (Part 2): Enpatoran 50 mg n=65 Participants 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=101 Participants 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.
Cohort A and B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24	3.0 scores on a scale Interval 0.3 to 5.8	2.0 scores on a scale Interval -0.7 to 4.7	6.9 scores on a scale Interval 4.2 to 9.6	4.3 scores on a scale Interval 1.7 to 6.8	2.4 scores on a scale Interval 0.4 to 4.4	4.8 scores on a scale Interval 2.5 to 7.0	3.6 scores on a scale Interval 1.4 to 5.8	5.1 scores on a scale Interval 3.3 to 6.9

Adverse Events

Cohort A: Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort A: Enpatoran 25 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort A: Enpatoran 50 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort A: Enpatoran 100 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort B (Part 1 + Part 2): Placebo

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Cohort B (Part 2): Enpatoran 25 mg

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Cohort B (Part 2): Enpatoran 50 mg

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Cohort B (Part 1 + Part 2): Enpatoran 100 mg

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A: Placebo n=26 participants at risk 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.	Cohort A: Enpatoran 25 mg n=24 participants at risk 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.	Cohort A: Enpatoran 50 mg n=26 participants at risk 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.	Cohort A: Enpatoran 100 mg n=26 participants at risk 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.	Cohort B (Part 1 + Part 2): Placebo n=95 participants at risk 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 participants at risk 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 participants at risk 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 participants at risk 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.
Infections and infestations Herpes zoster	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	3.8% 1/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Appendicitis	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.88% 1/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	4.2% 1/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	4.2% 1/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	4.2% 1/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	3.8% 1/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.88% 1/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Pneumonia	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.1% 1/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.8% 2/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.88% 1/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Septic shock	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.1% 1/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Urinary tract infection	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.1% 1/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Peripheral nerve injury	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Skin injury	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Product Issues Device dislocation	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.88% 1/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Surgical and medical procedures Abortion induced	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Vascular disorders Vein rupture	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	1.4% 1/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.

Other adverse events

Measure	Cohort A: Placebo n=26 participants at risk 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.	Cohort A: Enpatoran 25 mg n=24 participants at risk 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.	Cohort A: Enpatoran 50 mg n=26 participants at risk 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.	Cohort A: Enpatoran 100 mg n=26 participants at risk 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.	Cohort B (Part 1 + Part 2): Placebo n=95 participants at risk 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.	Cohort B (Part 2): Enpatoran 25 mg n=71 participants at risk 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.	Cohort B (Part 2): Enpatoran 50 mg n=74 participants at risk 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.	Cohort B (Part 1 + Part 2): Enpatoran 100 mg n=114 participants at risk 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.
Infections and infestations COVID-19	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	6.1% 7/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	5.6% 4/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Investigations Lymphocyte count decreased	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	5.3% 5/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Nervous system disorders Headache	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	8.3% 2/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	9.5% 7/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Gastrointestinal disorders Abdominal pain upper	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Herpes zoster	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Urinary tract infection	15.4% 4/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	8.4% 8/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	6.8% 5/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	9.6% 11/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Nasopharyngitis	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	8.1% 6/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	8.8% 10/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Influenza	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	6.3% 6/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.0% 5/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.4% 7/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	5.6% 4/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Infections and infestations Upper respiratory tract infection	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	8.3% 2/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	15.4% 4/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	19.2% 5/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	6.3% 6/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	9.9% 7/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	12.2% 9/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.0% 8/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Investigations Blood creatinine increased	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Investigations Weight increased	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/24 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	7.7% 2/26 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/95 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/71 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/74 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.	0.00% 0/114 • From screening up to safety follow up period (up to approximately 33 weeks) Participants were included in the treatment group in which they actually received study treatment.

Additional Information

Communication Center

Merck Healthcare KGaA, DarmstadtGermany, an affiliate of Merck KGaA,Darmstadt, Germany

Phone: 6151-72-5200

Email: service@emdgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place