PF-04965842 is an oral small molecule vaccine candidate that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD including interleukin (IL)-4, IL-13, IL-31, and interferon-gamma.
PF-04965842 is currently in clinical trials and is indicated for subjects aged 12 Years and older with moderate to severe atopic dermatitis
PF-04965842 is being tested as an oral vaccine with two different doses. 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation
May 15, 2019: Pfizer announced positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD).
Top-line results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo.
In addition, the results demonstrate a response to treatment for a statistically significant number of patients during the first two to four weeks following the first dose.
Clinical Trial NCT03349060: Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1)
- This Phase 3 study is 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.