INCB047986 in Rheumatoid Arthritis

NCT ID: NCT02151474

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

INCB047986 4 mg QD

INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days.

Group Type: EXPERIMENTAL

INCB047986

Intervention Type: DRUG

INCB047986 8 mg QD

INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days.

Group Type: EXPERIMENTAL

INCB047986

Intervention Type: DRUG

INCB047986 12 mg QD

INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days.

Group Type: EXPERIMENTAL

INCB047986

Intervention Type: DRUG

INCB047986 placebo QD

INCB047986 placebo will be orally self-administered once daily (QD) for 28 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Interventions

INCB047986

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women aged 18 to 75 years, inclusive.
• Body mass index between 18 and 40 kg/m^2, inclusive.
• Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
• Subjects must have active moderate to severe RA as determined by the following:

• ≥ 6 tender joints (28 joint count),
• ≥ 4 swollen joints (28 joint count), and
• CRP level ≥ 6 mg/L.
• Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.

Exclusion Criteria

• Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
• Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
• Onset of RA before the age of 16 years.
• History of known or currently suspected inflammatory disease other than RA
• Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks.
• Previous treatment with at Janus kinase (JAK) inhibitor.
• Significant impairment of bone marrow function present at screening
• Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Levy, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Orange, California, United States

DeBary, Florida, United States

Palm Harbor, Florida, United States

Tampa, Florida, United States

Frederick, Maryland, United States

Charlotte, North Carolina, United States

Oklahoma City, Oklahoma, United States

Austin, Texas, United States

The Woodlands, Texas, United States

Countries

United States

Other Identifiers

INCB 47986-202

Identifier Type: -

Identifier Source: org_study_id