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Completed

NCT Number: NCT03139136

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arensia, Tbilisi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
  • between 18 and 75 years of age, inclusive.

Exclusion criteria

  • Patients who are currently pregnant or breastfeeding.
  • Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy.
  • Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.

Treatment and study plan

MBS2320

Drug

As described in the arm descriptions

Placebo

Drug

As described in the arm descriptions

Primary outcomes

  1. Incidence of treatment-emergent adverse events (safety and tolerability)

    Time frame: 12 weeks

    Incidence of all grade adverse events

Secondary outcomes

  1. Disease Activity Score 28 (DAS28)

    Time frame: 12 weeks

    Disease Activity Score according to the EULAR response criteria

Sponsors and collaborators

Lead sponsor

Modern Biosciences Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 3, 2017
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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