NCT03139136

Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis

A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Modern Biosciences Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.

Detailed description

Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability. The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MBS2320	As described in the arm descriptions
DRUG	Placebo	As described in the arm descriptions

Timeline

• Start date: 2017-05-30
• Primary completion: 2018-11-16
• Completion: 2019-08-13
• First posted: 2017-05-03
• Last updated: 2019-08-14

Locations

3 sites across 3 countries: Georgia, Moldova, Romania