A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded-Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy

Conditions

Plaque Psoriasis

Brief summary

Period A: Achievement of PASI 100 at Week 16, Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 90 at Week 52

Detailed description

Period A: Achievement of PASI 100 at Week 16, Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 100 at Week 52, among subjects, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 52, among subjects

Related papers

No related papers found yet.

Interventions

DRUGABBV-066

DRUGDEUCRAVACITINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Period A: Achievement of PASI 100 at Week 16, Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 90 at Week 52	—

Secondary

Measure	Time frame
Period A: Achievement of PASI 100 at Week 16, Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 100 at Week 52, among subjects, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 52, among subjects	—

Measure

Time frame

Period A: Achievement of PASI 100 at Week 16, Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 100 at Week 52, among subjects, Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 52, among subjects

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Countries

Belgium, Germany, Greece, Hungary, Italy, Netherlands, Spain

Outcome results

None listed