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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03139136

Enrollment

121

Registered

2017-05-03

Start date

2017-05-30

Completion date

2019-08-13

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

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.

Interventions

DRUGMBS2320

As described in the arm descriptions

DRUGPlacebo

As described in the arm descriptions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Georgia, Moldova, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026