Phase 3
Completed N=387
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT03349060 ↗
Enrolled (actual)
387
Serious AEs
3.4%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12 — 23.7; 43.8; 7.9 percentage of participants — p=0.0037
◆ Published Evidence
Emerging
12citations · ~6 / year
Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies.
Summary
B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Linked Publications (5)
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Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies.
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Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis.
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Abrocitinib may improve itch and quality of life in patients with itch-dominant 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 Greater Than or Equal to 2 Points Improvement From Baseline at Week 12 |
23.7; 43.8; 7.9 | 0.0037 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12 |
39.7; 62.7; 11.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) |
20.4; 45.6; 2.7; 32.2; 58.8; 17.2 | 0.0004 sig |
| SECONDARY Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS) |
20.5; 47.6; 3.7; 34.0; 63.3; 20.7 | 0.0055 sig |
| SECONDARY Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set |
-1.5; -2.1; -0.5; -1.8; -3.0; -0.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set |
-2.4; -3.4; -1.1 | 0.0002 sig |
| SECONDARY Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus |
84.0; 14.0; 92.0 | 0.0071 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8 |
10.3; 24.0; 3.9; 27.6; 47.4; 14.5 | 0.0869 |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8 |
3.9; 9.7; 0; 10.5; 27.0; 5.3 | 0.0802 |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 |
0; 0; 0; 0; 6.6; 0 | 0.0234 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 |
34.2; 55.2; 10.4; 54.6; 73.7; 21.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 |
1.9; 5.2; 1.3; 7.9; 24.3; 3.9 | 0.7285 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 |
0; 0; 0; 0; 6.6; 0 | 0.0234 sig |
| SECONDARY Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 |
-9.8; -14.7; -4.1; -14.7; -19.6; -6.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 |
-11.8; -18.8; -4.0; -20.2; -27.0; -8.5 | 0.0004 sig |
| SECONDARY Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 |
2.6; 5.2; 1.3; 8.6; 27.6; 3.9 | 0.5210 |
| SECONDARY Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 |
14.9; 34.0; 4.0; 34.5; 50.7; 12.9 | 0.0151 sig |
| SECONDARY Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 |
1.4; 6.0; 0; 2.8; 18.2; 2.9 | 0.3151 |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 |
-2.1; -3.1; -0.8; -2.5; -3.7; -1.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 |
-16.4; -24.4; -5.5; -23.1; -32.6; -10.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 |
51.1; 68.9; 28.4; 62.7; 77.3; 44.8 | 0.0028 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 |
-5.9; -7.6; -2.1; -6.8; -9.6; -3.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 |
-4.5; -5.8; -3.3; -5.3; -8.2; -1.8 | 0.2750 |
| SECONDARY Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 |
10.0; 23.5; 3.4; 15.3; 32.5; 8.5 | 0.1238 |
| SECONDARY Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 |
3.2; 0; 0; 13.3; 9.7; 0 | 0.4795 |
| SECONDARY Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 |
67.5; 71.8; 35.7; 72.2; 85.2; 51.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 |
73.3; 74.2; 56.3; 69.0; 83.9; 40.0 | 0.2497 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 |
-0.7; -1.3; -0.2; -1.1; -1.7; 0.1 | 0.1718 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 |
-1.1; -1.7; -0.9; -1.4; -2.2; -1.0 | 0.6134 |
| SECONDARY Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 |
48.5; 64.7; 38.9; 50.0; 54.5; 55.6 | 0.5539 |
| SECONDARY Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 |
45.5; 60.0; 22.2; 68.2; 68.4; 55.6 | 0.2278 |
| SECONDARY Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 |
56.3; 46.2; 75.0; 56.3; 58.3; 75.0 | 0.4036 |
| SECONDARY Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 |
20.0; 75.0; 100.0; 60.0; 75.0; 66.7 | 0.0546 |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 |
-4.6; -8.1; -1.8; -6.2; -10.8; -2.4 | 0.0006 sig |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 |
-0.6; -1.1; -0.3; -0.8; -1.3; -0.4 | 0.0020 sig |
| SECONDARY Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 |
7.2; 19.2; 1.3; 14.6; 31.5; 5.4 | 0.0575 |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 |
0.049; 0.084; 0.016; 0.062; 0.092; 0.037 | 0.0453 sig |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 |
5.586; 9.697; 1.038; 6.207; 11.931; 1.846 | 0.0319 sig |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 |
0.115; 0.209; 0.119; 0.168; 0.278; -0.006 | 0.9568 |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 |
5.515; 14.933; 3.384; 5.359; 15.496; -1.494 | 0.6467 |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12 |
2.4; 3.3; -1.3 | 0.0102 sig |
| SECONDARY Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12 |
2.2; 2.1; 1.2 | 0.5241 |
| SECONDARY Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary |
4.3; 5.2; 0.5 | 0.0013 sig |
| SECONDARY Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary |
1.5; 2.8; -0.2 | 0.2256 |
| SECONDARY Plasma Concentration Versus Time Summary of PF-04965842 |
14.57; 58.16; 485.3; 889.7; 440.6; 933.9 | — |
Eligibility Criteria
Inclusion Criteria
- 12 years of age or older 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 4)
- Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control
Exclusion Criteria
- 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 nonAD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, 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 (NCT03349060) 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.