A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Conditions

Active Systemic Lupus Erythematosus (SLE)

Brief summary

Proportion of participants who achieve SRI(4) response at Week 52

Detailed description

Proportion of participants who achieve BICLA response at Week 52. Proportion of participants who achieve both SRI(4)and BICLA (dual responders) at Week 52., Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score at Week 52. Proportion of participants who achieve LLDAS at Week 52., Proportion of participants taking ≤7.5 mg per day CS at Week24 with no dose increase beyond protocol-specified limits to Week52. Proportion of participants with ≥ 6 active (tender+ swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints at Week 52., Change from baseline in patient-reported fatigue according to FACIT-Fatigue at Week 52. Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline and/or abnormalities in laboratory, electrocardiogram (ECG), and vital signs

Related papers

No related papers found yet.

Interventions

DRUGDeucravacitinib placebo film-coated tablets oral use

DRUGdeucravacitinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants who achieve SRI(4) response at Week 52	—

Secondary

Measure	Time frame
Proportion of participants who achieve BICLA response at Week 52. Proportion of participants who achieve both SRI(4)and BICLA (dual responders) at Week 52., Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score at Week 52. Proportion of participants who achieve LLDAS at Week 52., Proportion of participants taking ≤7.5 mg per day CS at Week24 with no dose increase beyond protocol-specified limits to Week52. Proportion of participants with ≥ 6 active (tender+ swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints at Week 52., Change from baseline in patient-reported fatigue according to FACIT-Fatigue at Week 52. Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline and/o	—

Measure

Time frame

Proportion of participants who achieve BICLA response at Week 52. Proportion of participants who achieve both SRI(4)and BICLA (dual responders) at Week 52., Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score at Week 52. Proportion of participants who achieve LLDAS at Week 52., Proportion of participants taking ≤7.5 mg per day CS at Week24 with no dose increase beyond protocol-specified limits to Week52. Proportion of participants with ≥ 6 active (tender+ swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints at Week 52., Change from baseline in patient-reported fatigue according to FACIT-Fatigue at Week 52. Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline and/o

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Countries

Bulgaria, Czechia, Greece, Hungary, Poland, Portugal, Spain

Outcome results

None listed