Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
Conditions
Keywords
BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus
Brief summary
The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit * Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol * Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant * Participant could be with or without concurrent systemic lupus erythematosus (SLE) * If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening
Exclusion criteria
* Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period * Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains * Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE) * Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit * History of 3 or more unexplained consecutive pregnancy losses * Active severe or unstable neuropsychiatric SLE * Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in CLASI Activity Score at Week 16 | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Mean Change From Baseline in CLASI-A Score. | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0. | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 Complete Response (CR) on CLASI-A defined as a score of 0. |
| Number of Participants With Safety Related Events in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with safety related events in the placebo controlled period |
| Number of Participants With Safety Related Events in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with safety related events in the active treatment period |
| Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant laboratory abnormalities in the active treatment period |
| Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant vital sign abnormalities in the placebo controlled period |
| Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant vital sign abnormalities in the active treatment period |
| Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period | From signing informed consent to end of active treatment period (Approximately 56 weeks) | Number of participants with clinically significant ECG abnormalities in the placebo controlled period |
| Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period | From signing informed consent to end of active treatment period (Approximately 56 weeks) | Number of participants with clinically significant ECG abnormalities in the active treatment period |
| Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant laboratory abnormalities in the placebo controlled period |
Countries
Argentina, Australia, France, Germany, Mexico, Poland, Taiwan, United States
Participant flow
Pre-assignment details
74 participants randomized and 73 treated in the placebo controlled period. 18 participants who received placebo in the placebo controlled period were randomized into 2 separate treatment arms during active treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo-Controlled Period: Treatment 1 Deucravactinib 3mg | 25 |
| Placebo-Controlled Period: Treatment 2 Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period | 25 |
| Placebo-Controlled Period: Placebo Placebo | 24 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Active Treatment Period | administrative reason by sponsor | 1 | 5 | 0 | 2 | 2 |
| Active Treatment Period | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 |
| Active Treatment Period | Ongoing Study Period | 2 | 4 | 0 | 1 | 0 |
| Active Treatment Period | other reasons | 1 | 1 | 0 | 0 | 1 |
| Active Treatment Period | request to discontinue | 0 | 1 | 0 | 1 | 0 |
| Placebo-Controlled Period | Ongoing study period | 0 | 1 | 0 | 0 | 0 |
| Placebo-Controlled Period | Pregnancy | 1 | 1 | 0 | 0 | 0 |
| Placebo-Controlled Period | Request to discontinue | 2 | 2 | 0 | 0 | 0 |
| Placebo-Controlled Period | withdrew consent | 1 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo-Controlled Period: Treatment 1 | Placebo-Controlled Period: Treatment 2 | Placebo-Controlled Period: Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 25 Participants | 21 Participants | 68 Participants |
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 15.06 | 42.8 Years STANDARD_DEVIATION 12.16 | 46.2 Years STANDARD_DEVIATION 12.82 | 45.4 Years STANDARD_DEVIATION 13.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 5 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 20 Participants | 11 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 17 Participants | 13 Participants | 13 Participants | 43 Participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 18 Participants | 54 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 | 0 / 24 | 0 / 16 | 0 / 20 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 15 / 25 | 15 / 24 | 8 / 24 | 11 / 16 | 10 / 20 | 5 / 9 | 6 / 9 |
| serious Total, serious adverse events | 2 / 25 | 2 / 24 | 1 / 24 | 1 / 16 | 0 / 20 | 0 / 9 | 1 / 9 |
Outcome results
Primary
Percentage Change From Baseline in CLASI Activity Score at Week 16
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Time frame: From first dose to Week 16 (approximately 16 weeks)
Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Percentage Change From Baseline in CLASI Activity Score at Week 16 | -48.56 Percentage change from baseline | Standard Deviation 44.684 |
| Placebo-Controlled Period: Treatment 2 | Percentage Change From Baseline in CLASI Activity Score at Week 16 | -48.93 Percentage change from baseline | Standard Deviation 33.302 |
| Placebo-Controlled Period: Placebo | Percentage Change From Baseline in CLASI Activity Score at Week 16 | -27.31 Percentage change from baseline | Standard Deviation 29.716 |
Secondary
Mean Change From Baseline in CLASI-A Score.
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Time frame: From first dose to Week 16 (approximately 16 weeks)
Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Mean Change From Baseline in CLASI-A Score. | -9.8 Score on a Scale | Standard Deviation 12.69 |
| Placebo-Controlled Period: Treatment 2 | Mean Change From Baseline in CLASI-A Score. | -7.5 Score on a Scale | Standard Deviation 5.92 |
| Placebo-Controlled Period: Placebo | Mean Change From Baseline in CLASI-A Score. | -4.3 Score on a Scale | Standard Deviation 5.54 |
Secondary
Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period
Number of participants with clinically significant ECG abnormalities in the active treatment period
Time frame: From signing informed consent to end of active treatment period (Approximately 56 weeks)
Population: All Treated Population in the active treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period | 0 Participants |
Secondary
Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period
Number of participants with clinically significant ECG abnormalities in the placebo controlled period
Time frame: From signing informed consent to end of active treatment period (Approximately 56 weeks)
Population: All Treated Population in the Placebo Controlled Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period
Number of participants with clinically significant laboratory abnormalities in the active treatment period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the active treatment period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | ALT > 3xULN | 0 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | AST > 3xULN | 0 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Creatinine Kinase ≥ 2.5x ULN | 3 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Hemoglobin < 9 g/dL (90g/L) | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | AST > 3xULN | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Creatinine Kinase ≥ 2.5x ULN | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Hemoglobin < 9 g/dL (90g/L) | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | ALT > 3xULN | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Creatinine Kinase ≥ 2.5x ULN | 2 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | AST > 3xULN | 1 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Hemoglobin < 9 g/dL (90g/L) | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | ALT > 3xULN | 1 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Hemoglobin < 9 g/dL (90g/L) | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | AST > 3xULN | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | ALT > 3xULN | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | Creatinine Kinase ≥ 2.5x ULN | 1 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period
Number of participants with clinically significant laboratory abnormalities in the placebo controlled period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the Placebo Controlled Period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Creatinine Kinase ≥ 2.5x ULN | 1 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Hemoglobin < 9 g/dL (90g/L) | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Creatinine Kinase ≥ 2.5x ULN | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Hemoglobin < 9 g/dL (90g/L) | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Creatinine Kinase ≥ 2.5x ULN | 2 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | Hemoglobin < 9 g/dL (90g/L) | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period
Number of participants with clinically significant vital sign abnormalities in the active treatment period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the active treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period
Number of participants with clinically significant vital sign abnormalities in the placebo controlled period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the Placebo Controlled Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | 0 Participants |
Secondary
Number of Participants With Safety Related Events in the Active Treatment Period
Number of participants with safety related events in the active treatment period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the active treatment period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Active Treatment Period | TEAEs | 11 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related TEAEs | 5 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Active Treatment Period | Serious TEAEs | 1 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related serious TEAE | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related TEAEs | 5 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Serious TEAEs | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related serious TEAE | 0 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | TEAEs | 10 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Active Treatment Period | Serious TEAEs | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related TEAEs | 2 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related serious TEAE | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Active Treatment Period | TEAEs | 5 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related serious TEAE | 0 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Treatment related TEAEs | 2 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | TEAEs | 6 Participants |
| Active-Treatment Period: Treatment 2 | Number of Participants With Safety Related Events in the Active Treatment Period | Serious TEAEs | 1 Participants |
Secondary
Number of Participants With Safety Related Events in the Placebo Controlled Period
Number of participants with safety related events in the placebo controlled period
Time frame: From signing informed consent to end of safety follow up period (Approximately 60 weeks)
Population: All Treated Population in the Placebo Controlled Period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Placebo Controlled Period | TEAE | 17 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment-related TEAEs | 11 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Serious TEAE | 2 Participants |
| Placebo-Controlled Period: Treatment 1 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment related Serious TEAE | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment related Serious TEAE | 1 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Placebo Controlled Period | TEAE | 19 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Serious TEAE | 2 Participants |
| Placebo-Controlled Period: Treatment 2 | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment-related TEAEs | 11 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment related Serious TEAE | 0 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Placebo Controlled Period | Treatment-related TEAEs | 3 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Placebo Controlled Period | Serious TEAE | 1 Participants |
| Placebo-Controlled Period: Placebo | Number of Participants With Safety Related Events in the Placebo Controlled Period | TEAE | 12 Participants |
Secondary
Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0.
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 Complete Response (CR) on CLASI-A defined as a score of 0.
Time frame: From first dose to Week 16 (approximately 16 weeks)
Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0. | 12.0 Percentage of Participants |
| Placebo-Controlled Period: Treatment 2 | Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0. | 4.2 Percentage of Participants |
| Placebo-Controlled Period: Placebo | Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0. | 0 Percentage of Participants |
Secondary
Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Time frame: From first dose to Week 16 (approximately 16 weeks)
Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | 60.0 Percentage of participants |
| Placebo-Controlled Period: Treatment 2 | Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | 66.7 Percentage of participants |
| Placebo-Controlled Period: Placebo | Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | 39.1 Percentage of participants |
Secondary
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Time frame: From first dose to Week 16 (approximately 16 weeks)
Population: All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Controlled Period: Treatment 1 | Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | 60.0 Percentage of participants |
| Placebo-Controlled Period: Treatment 2 | Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | 54.2 Percentage of participants |
| Placebo-Controlled Period: Placebo | Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | 21.7 Percentage of participants |