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

August 13, 2019 updated by: Modern Biosciences Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
As described in the arm descriptions
Active Comparator: MBS2320
Drug: MBS2320
As described in the arm descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (safety and tolerability)
Time Frame: 12 weeks
Incidence of all grade adverse events
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity Score 28 (DAS28)
Time Frame: 12 weeks
Disease Activity Score according to the EULAR response criteria
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Modern Biosciences Ltd

Investigators

  • Principal Investigator: Inga Bodrug, MD, ARENSIA Exploratory Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Actual)

November 16, 2018

Study Completion (Actual)

August 13, 2019

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120012A
  • 2016-004038-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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