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

Sponsor
Modern Biosciences Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03139136
Collaborator
(none)
121
Enrollment
3
Locations
2
Arms
26.4
Actual Duration (Months)
40.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
May 30, 2017
Actual Primary Completion Date :
Nov 16, 2018
Actual Study Completion Date :
Aug 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MBS2320

Drug: MBS2320
As described in the arm descriptions
Placebo Comparator: Placebo

Drug: Placebo
As described in the arm descriptions

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events (safety and tolerability) [12 weeks]

    Incidence of all grade adverse events

Secondary Outcome Measures

  1. Disease Activity Score 28 (DAS28) [12 weeks]

    Disease Activity Score according to the EULAR response criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arensia Tbilisi Georgia
2 Arensia Chisinau Moldova, Republic of
3 Arensia Bucharest Romania

Sponsors and Collaborators

  • Modern Biosciences Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Modern Biosciences Ltd
ClinicalTrials.gov Identifier:
NCT03139136
Other Study ID Numbers:
  • 120012A
  • 2016-004038-24
First Posted:
May 3, 2017
Last Update Posted:
Aug 14, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Aug 14, 2019