Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akros Pharma Inc.

Criteria

Inclusion Criteria:

• A diagnosis of RA prior to the Screening Visit.

• Active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the Screening and Baseline Visits.

• Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

Exclusion Criteria:

• Prior/current exposure to biologic and/or kinase inhibitor therapy.

• Known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.

• Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or hepatitis C (HCV) virus at the Screening Visit.

• Positive drug of abuse and alcohol test results.

• History of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to Day 1.