drugset
drugset / Trial / NCT03163966

A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

NCT03163966 ↗

Phase 2 Completed 248 enrolled Rottapharm Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

CR6086 is a new, potent and selective, orally available, small molecule prostaglandin EP4 receptor antagonist, endowed with immunomodulatory properties. The pharmacological properties of CR6086, along with its oral bioavailability, predictable pharmacokinetics and good safety, make it the ideal candidate to be tested alone or in combination with methotrexate (MTX) in patients with early Rheumatoid Arthritis who are naïve to Disease-Modifying Antirheumatic Drugs (DMARDs). The compound has indeed the potential to provide a safer and more effective treatment than MTX (or other conventional synthetic DMARDs - csDMARDs), and could significantly improve the proportion of responder patients and avoid/delay the recourse to biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs).

Timeline

Start
2017-10-05
Primary completion
2019-01-08
Completion
2019-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorbipiprant Small molecule 30 mg Oral
Subject Vorbipiprant Small molecule 90 mg Oral
Subject Vorbipiprant Small molecule 180 mg Oral
Background Methotrexate Small molecule — Oral

Indications

No indication recorded.