NCT03963401

A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	PF-06700841	Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
OTHER	Placebo	Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.

Timeline

• Start date: 2019-06-13
• Primary completion: 2020-04-06
• Completion: 2021-01-15
• First posted: 2019-05-24
• Last updated: 2021-08-04
• Results posted: 2021-08-04

Locations

48 sites across 11 countries: Australia, Bulgaria, Czechia, Estonia, Hungary, Lithuania, Poland, Russia, Serbia, Slovakia, Spain

Regulatory

• FDA-regulated drug study