Phase 3
N=912
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03569293 ↗Enrolled (actual)
912
Serious AEs
2.4%
Results posted
Feb 2022
Primary outcome: Primary: Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 — 16.3; 69.6; 79.7 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo for Upadacitinib (Drug); Upadacitinib (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 |
16.3; 69.6; 79.7 | <0.001 sig |
| PRIMARY Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 |
8.4; 48.1; 62.0 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 |
11.8; 52.2; 60.0 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 |
8.1; 53.1; 65.8 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 |
4.4; 51.5; 66.8 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 |
3.6; 38.1; 47.4 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 |
0.4; 15.0; 19.6 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2 |
3.7; 10.5; 11.8 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3 |
3.3; 16.4; 21.1 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period |
25.2; 1.1; 0.0 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16 |
13.2; 55.0; 66.1 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16 |
15.0; 53.6; 63.5 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16 |
15.0; 53.6; 67.9 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16 |
19.8; 62.6; 72.6 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16 |
20.3; 65.0; 73.2 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 |
1.8; 16.7; 27.0 | <0.001 sig |
| SECONDARY Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16 |
-26.06; -62.79; -72.04 | <0.001 sig |
| SECONDARY Main Study: Percent Change From Baseline in EASI Score at Week 16 |
-40.71; -80.24; -87.74 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16 |
22.8; 75.0; 81.4 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
29.0; 75.4; 82.0 | <0.001 sig |
| SECONDARY Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16 |
-32.68; -65.71; -73.07 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16 |
14.3; 45.5; 49.2 | <0.001 sig |
| SECONDARY Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16 |
4.4; 30.3; 41.5 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16 |
11.5; 73.4; 78.1 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 |
6.6; 45.3; 64.1 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16 |
10.0; 48.4; 56.5 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16 |
3.3; 46.9; 67.2 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 |
3.3; 48.4; 58.1 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2 |
3.3; 39.1; 50.4 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 |
0.0; 9.7; 21.0 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2 |
1.7; 8.3; 12.7 | 0.015 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3 |
5.1; 16.7; 15.9 | 0.045 sig |
| SECONDARY Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period |
22.0; 0.0; 0.0 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16 |
12.5; 46.9; 66.0 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16 |
9.1; 42.6; 64.4 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16 |
16.3; 51.9; 67.3 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16 |
23.9; 61.7; 78.7 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16 |
30.2; 58.1; 81.4 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16 |
0.0; 15.6; 31.3 | <0.001 sig |
| SECONDARY Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16 |
-24.40; -58.28; -66.82 | <0.001 sig |
| SECONDARY Adolescents: Percent Change From Baseline in EASI Score at Week 16 |
-43.19; -81.04; -85.03 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16 |
31.0; 81.0; 85.9 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16 |
36.4; 82.1; 81.3 | <0.001 sig |
| SECONDARY Adolescents: Percent Change From Baseline in SCORAD Score at Week 16 |
-32.52; -65.22; -71.44 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16 |
3.8; 48.6; 55.6 | <0.001 sig |
| SECONDARY Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16 |
4.5; 21.4; 30.3 | 0.006 sig |
Summary
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Eligibility Criteria
Inclusion Criteria
- Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe AD defined by:
- Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
- Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
- ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
- Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit
Exclusion Criteria
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis 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
Data sourced from ClinicalTrials.gov (NCT03569293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.