NCT02151474

INCB047986 in Rheumatoid Arthritis

A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.

Detailed description

This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	INCB047986
DRUG	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-05-30
• Last updated: 2015-02-23

Locations

9 sites across 1 country: United States