Phase 3
Completed N=285
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03796676 ↗Enrolled (actual)
285
Serious AEs
1.1%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 — 24.5; 41.6; 46.2 Percentage of participants — p=0.0147
◆ Published Evidence
Highly cited
160citations · ~32 / year
Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial.
Summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD.
Linked Publications (5)
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Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial.
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Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes.
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Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis.
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Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis.
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Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12 |
24.5; 41.6; 46.2 | 0.0147 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12 |
41.5; 68.5; 72.0 | 0.0002 sig |
| SECONDARY Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 |
12.6; 27.2; 38.6; 20.7; 31.5; 50.0 | 0.0119 sig |
| SECONDARY Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12 |
-2.0; -2.5; -2.7 | 0.0664 |
| SECONDARY Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 |
1.1; 6.5; 12.8; 3.1; 19.6; 38.3 | — |
| SECONDARY Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 |
4.4; 19.6; 25.5; 14.6; 41.3; 63.8 | — |
| SECONDARY Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline |
24.2; 55.4; 64.9; 51.0; 75.0; 81.9 | — |
| SECONDARY Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline |
0; 8.7; 10.6; 2.1; 17.4; 30.9 | — |
| SECONDARY Percentage of Participants Achieving EASI Response =100% Improvement From Baseline |
0; 1.1; 0; 0; 2.2; 5.3 | — |
| SECONDARY Percent Change From Baseline in EASI Score |
-27.6; -51.5; -54.5; -41.7; -66.1; -74.3 | — |
| SECONDARY Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 |
1.2; 2.8; 3.9; 0; 5.1; 7.7 | — |
| SECONDARY Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus |
90.0; 70.0; 29.0 | — |
| SECONDARY Percent Change From Baseline in PP-NRS for Severity of Pruritus |
-0.9; -9.5; -5.4; -1.1; -11.3; -10.2 | — |
| SECONDARY Change From Baseline in Percentage Body Surface Area (BSA) |
-10.9; -21.0; -20.7; -15.1; -27.7; -32.6 | — |
| SECONDARY Percent Change From Baseline in Percentage BSA |
-20.6; -40.4; -42.2; -29.0; -55.4; -66.0 | — |
| SECONDARY Percentage of Participants Achieving Percentage BSA < 5% at Week 12 |
24.5; 38.2; 36.6 | — |
| SECONDARY Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline |
8.6; 22.6; 29.0; 24.0; 44.1; 64.1 | — |
| SECONDARY Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline |
0; 5.4; 7.5; 0; 11.8; 21.7 | — |
| SECONDARY Change From Baseline in SCORAD Total Score |
-12.3; -24.6; -25.8; -20.2; -32.4; -38.0 | — |
| SECONDARY Percent Change From Baseline in SCORAD Total Score |
-18.7; -36.1; -38.7; -30.0; -47.4; -56.9 | — |
| SECONDARY Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss |
-0.9; -2.1; -2.6; -1.8; -2.9; -3.4 | — |
| SECONDARY Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss |
2.6; 65.1; -36.5; -20.0; -35.2; -53.4 | — |
| SECONDARY Number of Days When a Corticosteroid Not Used up to Day 88 |
6.8; 10.9; 15.1 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (DLQI) |
-4.2; -6.1; -6.3; -5.4; -7.3; -7.6 | — |
| SECONDARY Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI |
61.5; 73.6; 71.3; 73.7; 82.4; 73.4 | — |
| SECONDARY Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) |
-1.2; -1.6; -1.3; -1.5; -1.6; -1.9 | — |
| SECONDARY Change From Baseline in Depression of HADS |
-0.8; -1.2; -0.8; -0.8; -1.3; -1.3 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) |
-3.4; -6.9; -8.2; -4.8; -9.5; -10.6 | — |
| SECONDARY Change From Baseline in Dermatitis Family Impact (DFI) at Week 12 |
-5.2; -6.7; -7.3 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) |
-0.4; -0.7; -1.0; -0.7; -0.9; -1.2 | — |
| SECONDARY Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA |
1.1; 5.4; 5.3; 4.2; 14.1; 20.2 | — |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score |
7.140; 11.241; 12.141; 8.784; 13.222; 14.677 | — |
| SECONDARY Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 |
2.5; 4.5; 4.3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
50; 54; 59; 16; 20; 31 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
2; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Discontinued From the Study Due to TEAEs |
2; 1; 2; 0; 0; 2 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Categorization of Vital Signs Data Meeting Prespecified Criteria |
3; 1; 9; 3; 6; 6 | — |
| SECONDARY Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination |
14.00; 6.51; 34.61; 15.19; 11.48; 22.77 | — |
| SECONDARY Plasma PF-04965842 Concentration at Week 8 |
7.882; 32.33 | — |
| SECONDARY Plasma PF-04965842 Concentration at Week 12 |
486.6; 1271 | — |
Eligibility Criteria
Inclusion Criteria
- Aged between 12 and to 17 with a minimum body weight of 40 kg
- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
Exclusion Criteria
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with JAK inhibitors
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Data sourced from ClinicalTrials.gov (NCT03796676) and the linked publication. 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. Informational only — not medical advice.