Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
Summary
Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Met primary endpoint
Stopped (Business): “Study terminated 26 June 2015 due to changes in the drug development portfolio. This study was not terminated for reasons of safety and/or efficacy”
registry analysis (superiority or other test); Placebo vs PF-04965842 200 Milligram (mg) Once Daily; Least square (LS) mean difference -5.08 (90% CI -9.15 to -1.01) NCT02201524 ↗
registry analysis (superiority or other test); Placebo vs PF-04965842 400 mg Once Daily; LS mean difference -5.61 (90% CI -9.61 to -1.62) NCT02201524 ↗
registry analysis (superiority or other test); Placebo vs PF-04965842 200 mg Twice Daily; LS mean difference -9.98 (90% CI -14.19 to -5.77) NCT02201524 ↗
Publications
- Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. 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. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
- Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.
- Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abrocitinib | Small molecule | 200 mg | Oral |
| Subject | Abrocitinib | Small molecule | 400 mg | Oral |