Phase 3
Completed N=391
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT03575871 ↗
Enrolled (actual)
391
Serious AEs
2.1%
Results posted
Apr 2020
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 — 28.4; 38.1; 9.1 percentage of participants — p=0.0008
◆ Published Evidence
Emerging
12citations · ~6 / year
Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies.
Summary
B7451013 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 |
28.4; 38.1; 9.1 | 0.0008 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12 |
44.5; 61.0; 10.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12 |
23.1; 35.3; 3.9; 31.4; 50.3; 3.9 | 0.0002 sig |
| SECONDARY Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12 |
-2.4; -3.0; -0.8 | <0.0001 sig |
| SECONDARY Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus |
58.0; 29.0; 112.0 | — |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8 |
10.2; 24.3; 1.3; 26.5; 51.0; 6.5 | 0.0150 sig |
| SECONDARY Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8 |
5.1; 14.5; 0; 14.2; 33.3; 1.3 | 0.0459 sig |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12 |
0; 2.0; 0; 1.9; 4.6; 0 | 0.2262 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12 |
35.7; 55.3; 10.5; 58.7; 78.4; 28.6 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12 |
2.5; 9.2; 0; 9.7; 22.9; 0 | 0.1623 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12 |
0; 1.3; 0; 1.3; 3.9; 0 | 0.3261 |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12 |
-39.2; -51.3; -9.0; -54.3; -69.0; -24.4 | <0.0001 sig |
| SECONDARY Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12 |
-27.8; -35.4; -1.3; -45.0; -55.7; -15.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12 |
1.9; 5.9; 0; 6.5; 17.0; 0 | 0.2353 |
| SECONDARY Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12 |
12.7; 32.9; 0; 36.1; 60.8; 7.8 | 0.0011 sig |
| SECONDARY Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12 |
1.9; 5.3; 0; 7.1; 17.6; 0 | 0.2261 |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12 |
-2.3; -3.5; -0.6; -3.1; -4.3; -1.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12 |
-1.9; -2.9; -0.5; -2.8; -3.9; -1.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12 |
-27.2; -38.5; -6.3; -38.9; -53.1; -17.2 | <0.0001 sig |
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 severity 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 (NCT03575871) 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.