Phase 3
Completed N=1,235
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
dermatitis · Dermatitis, Atopic · Atopic Dermatitis · Skin Diseases
Source: ClinicalTrials.gov NCT03627767 ↗
Enrolled (actual)
1,235
Serious AEs
2.1%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Loss of Response: Double-blind (DB) Period — 77.5; 39.6; 16.5 percentage of participants
◆ Published Evidence
Emerging
12citations · ~4 / year
Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial.
Summary
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Linked Publications (5)
-
Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial.
-
Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis.
-
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.
-
Sustained on/off-treatment disease control with abrocitinib for moderate-to-severe atopic dermatitis.
-
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 With Loss of Response: Double-blind (DB) Period |
77.5; 39.6; 16.5 | — |
| PRIMARY Time to Loss of Response: Double-blind Period |
28.0; 323.0; NA | < 0.0001 sig |
| SECONDARY Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period |
27.0; 78.0; 201.0 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period |
99.6; 99.6; 99.2; 15.4; 55.5; 77.8 | = 0.9495 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
100.0; 100.0; 100.0; 40.8; 83.3; 96.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
99.2; 100.0; 99.6; 27.0; 76.0; 92.5 | = 0.1848 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
84.6; 87.1; 86.4; 13.9; 51.3; 77.1 | = 0.3994 |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
30.5; 30.3; 28.3; 3.7; 15.2; 28.9 | = 0.9313 |
| SECONDARY Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
82.2; 84.0; 81.9; 15.9; 54.6; 75.6 | = 0.6082 |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-95.6; -96.7; -96.7; -68.5; -90.9; -96.3 | — |
| SECONDARY Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-84.0; -84.4; -84.4; -50.4; -71.7; -83.6 | — |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-6.1; -6.1; -6.1; 3.4; 1.2; 0.2 | = 0.9207 |
| SECONDARY Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
97.4; 98.5; 97.0; 25.6; 72.0; 89.1 | = 0.4244 |
| SECONDARY Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
73.6; 75.0; 71.3; 9.4; 38.3; 67.3 | = 0.7232 |
| SECONDARY Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
30.7; 54.6; 60.2; 64.1 | — |
| SECONDARY Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
-71.1; -82.0; -86.4; -87.3 | — |
| SECONDARY Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
56.6; 63.2; 67.2; 56.2 | — |
| SECONDARY Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
-62.8; -76.4; -82.1; -83.3 | — |
| SECONDARY Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
-57.3; -67.5; -68.6; -67.3; -62.5; -72.4 | — |
| SECONDARY Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
55.0; 76.1; 79.6; 79.8 | — |
| SECONDARY Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period |
16.9; 33.9; 44.4; 45.4 | — |
| SECONDARY Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
61.7; 64.5; 59.7; 5.9; 29.8; 48.3 | = 0.4815 |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-13.5; -13.4; -13.5; 6.9; 1.9; 0.4 | = 0.7373 |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-9.8; -9.2; -9.3; 5.9; 1.7; -0.3 | = 0.3339 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-2.7; -2.6; -2.6; 1.4; 0.3; 0.0 | = 0.7556 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-2.0; -1.6; -1.7; 1.4; 0.0; 0.0 | = 0.0674 |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-15.4; -15.8; -15.4; 9.8; 3.7; 0.6 | = 0.3531 |
| SECONDARY Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period |
-4.1; -4.2; -4.2; 2.1; 0.8; 0.1 | = 0.4832 |
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: BSA10%, 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 (NCT03627767) 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.