Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
Conditions
Brief summary
Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16, Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
Detailed description
Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected, Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24, Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24, Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction, Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction, Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24, Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24, Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24, Cohort B: Remission Attainment at Week 24, Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24, Cohort B: Change from Baseline in Physician's Global Assessment at Week 24, Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare, Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare, Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24, Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24, Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24, Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16, Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected, Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24, Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24, Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction, Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction, Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24, Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24, Cohort B: L | — |
Countries
Bulgaria, Greece, Poland, Romania, Spain