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

NCT03163966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-10-05

No results posted yet for this study

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).

Conditions

  • Rheumatoid Arthritis, DMARD-naive and Early Disease Patients

Interventions

DRUG

CR6086

oral CR6086 capsules

DRUG

Methotrexate

oral Methotrexate tablets

DRUG

Placebo

oral CR6086 Placebo capsules

Sponsors & Collaborators

  • Rottapharm Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Czechia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163966 on ClinicalTrials.gov