Clinical Trials

Date: 2017-12-14

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Pfizer (USA - NY)

Product: PF-04965842

Action mechanism:

janus kinase inhibitor. PF-04965842 is an oral small molecule that selectively inhibits Janus kinase 1 (JAK1). Inhibition of JAK1 modulates multiple cytokines involved in pathophysiology of atopic dermatitis including interleukin (IL)-4, IL-13, IL-31 and interferon gamma (IFN?).

Disease: moderate-to-severe atopic dermatitis (AD)

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country: USA

Trial details:

This Phase 3 trial ( B7451012) is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of PF-04965842 in 375 patients 12 years and older with moderate-to-severe atopic dermatitis. Trial participants will be randomly assigned to receive 200 mg or 100 mg once daily or placebo.
The primary endpoints are the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and ?2 point improvement, and the proportion of patients with at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score.
Key secondary endpoints include the pruritus numerical rating scale, the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) electronic diary and safety measures such as the incidence of treatment emergent adverse events and laboratory abnormalities.
The treatment duration will be 12 weeks, the same duration as the Phase 2b study B7451006, with a 4 week safety follow-up period or the option to enter a long-term extension study (B7451015) at Week 12.
The design of the Phase 3 trial is based on the Phase 2 results that were presented at the 26th Congress of the European Academy of Dermatology and Venereology in September 2017. (NCT03349060)

Latest news:

• On December 14, 2017, Pfizer announced the initiation of a Phase 3 program for its once-daily Janus kinase 1 (JAK1) inhibitor PF-04965842, to evaluate its efficacy and safety for the treatment of moderate-to-severe atopic dermatitis (AD). This is the first trial in the J AK1 A topic D ermatitis E fficacy and safety (JADE) global development program.