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A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502937-24-00
Acronym
M16-047
Enrollment
444
Registered
2023-09-20
Start date
2019-01-02
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16, Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.

Detailed description

Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16, Percent change from Baseline of Worst Pruritus NRS at Week 16, Percent change in EASI score from Baseline at Week 16., Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving EASI 75 at Week 4, Proportion of subjects achieving EASI 75 at Week 2, Proportion of subjects achieving EASI 90 at Week 4, Proportion of subjects achieving EASI 100 at Week 16 for 30 mg, Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline.

Interventions

DRUGTACROLIMUS
DRUGTRIAMCINOLONE
DRUGHYDROCORTISONE
DRUGPIMECROLIMUS
DRUGUpadacitinib

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16, Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.

Secondary

MeasureTime frame
Proportion of subjects achieving an improvement (reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16, Percent change from Baseline of Worst Pruritus NRS at Week 16, Percent change in EASI score from Baseline at Week 16., Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline, Proportion of subjects achieving EASI 75 at Week 4, Proportion of subjects achieving EASI 75 at Week 2, Proportion of subjects achieving EASI 90 at Week 4, Proportion of subjects achieving EASI 100 at Week 16 for 30 mg, Proportion of subjects achieving an improvement (reduction) in Worst Pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with Worst Pruritus NRS ≥ 4 at Baseline.

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026