A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)

Conditions

Dermatitis atopic

Brief summary

Achievement of EASI 90 at Week 24

Detailed description

Achievement of EASI 75 / 100 at Week 24., Achievement of EASI 75 / 90 / 100 at Week 12., Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24., Achievement of a vIGA-AD of 0 or 1 at Week 12., Achievement of vIGA-AD of 0 or 1 at Week 24., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24., Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 24., Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12., Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.

Related papers

No related papers found yet.

Interventions

DRUGUpadacitinib

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Achievement of EASI 90 at Week 24	—

Secondary

Measure	Time frame
Achievement of EASI 75 / 100 at Week 24., Achievement of EASI 75 / 90 / 100 at Week 12., Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24., Achievement of a vIGA-AD of 0 or 1 at Week 12., Achievement of vIGA-AD of 0 or 1 at Week 24., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24., Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subj	—

Measure

Time frame

Achievement of EASI 75 / 100 at Week 24., Achievement of EASI 75 / 90 / 100 at Week 12., Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24., Achievement of a vIGA-AD of 0 or 1 at Week 12., Achievement of vIGA-AD of 0 or 1 at Week 24., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12., Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24., Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12., Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subj

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Countries

Belgium, Bulgaria, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain

Outcome results

None listed