2022-502938-30-00
Active, not recruiting
Phase 3
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis
Abbvie Deutschland GmbH & Co. KG30 sites in 9 countries187 target enrollmentStarted: July 18, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 187
- Locations
- 30
- Primary Endpoint
- 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
Overview
Brief Summary
To assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe Atopic Dermatitis who are candidates for systemic therapy.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Blinded Extension period of up to Week 260
- Masking
- Double (Subject, Monitor, Investigator, Analyst, Carer)
Eligibility Criteria
- Ages
- 0 years to 65+ years (18-64 Years, 65+ Years, 0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female subjects 12-75 years of age
- •Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus
- •Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
Exclusion Criteria
- •Prior exposure to any JAK inhibitor
- •Unable or unwilling to discontinue current AD treatments prior to the study
- •Requirement of prohibited medications during the study
- •Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Outcomes
Primary Outcomes
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 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.
Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16.
Secondary Outcomes
- Proportion of subjects achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline at Week 16 for subjects with pruritus NRS ≥4 at baseline;
- Proportion of subjects achieving EASI 90 at Week 16
- Percent change from Baseline of worst pruritus NRS at Week 16
- Percent change in EASI 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 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 an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Week 1 for subjects with pruritus NRS ≥ 4 at Baseline
- Proportion of subjects achieving an improvement (reduction) in Patient Oriented Eczema Measure (POEM) ≥ 4 from Baseline at Week 16 for subjects with POEM ≥ 4 at Baseline
- Proportion of subjects age ≥ 16 years old at screening achieving an improvement (reduction) in Dermatology Life Quality Index (DLQI) ≥ 4 from Baseline at Week 16 for subjects with DLQI ≥ 4 at Baseline
- Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Day 2 for subjects with pruritus NRS ≥ 4 at Baseline (upadacitinib 30 mg vs. placebo)
- Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Day 3 for subjects with pruritus NRS ≥ 4 at Baseline (upadacitinib 15 mg vs. placebo)
- Proportion of subjects achieving EASI 50 at Week 1
- Proportion of subjects experiencing a flare, characterized as a clinically meaningful worsening in EASI, defined as an increase of EASI by ≥ 6.6 from Baseline, during double-blind treatment period (DB Period)
- Proportion of subjects age ≥ 16 years old at screening achieving DLQI score of 0 or 1 at Week 16
- Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline at Week 16
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 16
- Proportion of subjects achieving a Hospital Anxiety and Depression Scale-anxiety (HADS-A) < 8 and Hospital Anxiety and Depression Scale depression (HADS-D) < 8 at Week 16 among subjects with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline
- Proportion of subjects achieving an improvement (reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) sleep domain score ≥ minimal clinically important difference (MCID) from Baseline at Week 16 for subjects with ADerm-IS sleep domain score ≥ MCID at Baseline
- Proportion of subjects achieving an improvement (reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) skin pain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-SS skin pain score ≥ MCID at Baseline
- Proportion of subjects achieving an improvement (reduction) in ADerm-SS 7-item total symptom score (TSS-7) ≥ MCID from Baseline at Week 16 for subjects with ADerm TSS-7 ≥ MCID at Baseline; ADerm-SS TSS-7 is defined as the algebraic sum of the responses to items 1 – 7 of the ADerm-SS
- Proportion of subjects achieving an improvement (reduction) in ADerm-IS emotional state domain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-IS emotional state domain score ≥ MCID at Baseline
- Proportion of subjects achieving an improvement (reduction) in ADerm-IS daily activities domain score ≥ MCID from Baseline at Week 16 for subjects with ADerm-IS daily activities domain score ≥ MCID at Baseline
- Proportion of subjects achieving EASI 100 at Week 16
- Proportion of subjects achieving an improvement (reduction) in ADerm-SS TSS-7 ≥ MCID from Baseline at Week 4 for subjects with ADerm-SS TSS-7 ≥ MCID at Baseline
- Proportion of subjects achieving an improvement (reduction) in ADerm-IS sleep domain score ≥ MCID from Baseline at Week 4 for subjects with ADerm-IS sleep domain score ≥ MCID at Baseline
- Proportion of subjects achieving a vIGA-AD of 0 with a reduction from Baseline of ≥ 2 points at Week 16
Investigators
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
Study Sites (30)
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