Systemic Lupus Erythematosus
Conditions
Brief summary
Adverse events and serious adverse events, vital sign measurements, and laboratory parameters
Detailed description
Efficacy: CLASI response, 40-joint count for tender, swollen, and tender + swollen joints, SRI(4) response, BICLA response, PGA, Corticosteroid use (yes/no), Corticosteroid dose ≤7.5 mg/day (yes/no), Flare Analysis o Time to first flare o Number and frequency of flares o Flares leading to hospitalization, SDI total score, BILAG response, SLEDAI-2K score, LLDAS response, PROMIS Fatigue Short Form 7a score, Pharmacokinetic: - Plasma concentrations of BMS-986165, Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR
Interventions
DRUGdeucravacitinib 12 mg tablet
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events, vital sign measurements, and laboratory parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: CLASI response, 40-joint count for tender, swollen, and tender + swollen joints, SRI(4) response, BICLA response, PGA, Corticosteroid use (yes/no), Corticosteroid dose ≤7.5 mg/day (yes/no), Flare Analysis o Time to first flare o Number and frequency of flares o Flares leading to hospitalization, SDI total score, BILAG response, SLEDAI-2K score, LLDAS response, PROMIS Fatigue Short Form 7a score, Pharmacokinetic: - Plasma concentrations of BMS-986165, Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR | — |
Countries
Hungary, Poland, Romania, Spain
Outcome results
None listed