Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03796676 | JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis | PHASE3 | COMPLETED | 287 | — | — | Feb 18, 2019 | Apr 8, 2020 | Apr 13, 2022 | 136 | United States, Australia +12 |
| NCT03915496 | Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis | PHASE2 | COMPLETED | 46 | — | — | Jun 18, 2020 | Nov 16, 2021 | Feb 8, 2023 | 11 | United States, Canada |
| NCT02780167 | Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis | PHASE2 | COMPLETED | 269 | — | — | Apr 1, 2016 | Apr 1, 2017 | May 2, 2019 | 64 | United States, Australia +3 |
The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Mean fold-changes from baseline at Week 12 in the biomarkers for general inflammation (Matrix Metallopeptidase \[MMP\]12), hyperplasia (Keratin \[KRT\]16), Th2 immune response (C-C motif chemokine ligand \[CCL\]17, CCL18, CCL26), and Th22 immune response (S100 calcium binding protein A \[S100A\]8, S100A9, S100A12), in lesional (LS) and non-lesional (NL) skin tissues, respectively. Expression levels from RT-PCR are normalized to the housekeeping gene RPLP0 by negatively transforming the Ct values to -dCt.
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PF-04965842 100 mg QD | EXPERIMENTAL | active |
| PF-04965842 200 mg QD | EXPERIMENTAL | active |
| PF-04965842 200 mg | EXPERIMENTAL | - |
| PF-04965842 100 mg | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | 10 mg of PF-04965842 QD |
| Cohort 2 | EXPERIMENTAL | 30 mg of PF-04965842 QD |
| Cohort 3 | EXPERIMENTAL | 100 mg of PF-04965842 QD |
| Cohort 4 | EXPERIMENTAL | 200 mg of PF-04965842 QD |
| Cohort 5 | PLACEBO_COMPARATOR | placebo QD |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-04965842 | DRUG | 100 mg QD |
| PF04965842 | DRUG | 200 mg QD |
| PF-04965842 200 mg | DRUG | PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks |
| PF-04965842 100 mg | DRUG | PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks |
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 o...