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Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone

NCT05460832•Modern Biosciences Ltd

View on ClinicalTrials.gov

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. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR criteria for ≥3 months prior to screening.
•2. Has active RA as defined by the following minimum disease activity criteria:
•* ≥6 swollen joints (based on 66 joint counts)
•* ≥6 tender joints (based on 68 joint counts)
•* hsCRP \> upper limit of normal reference range (ULN)
•3. Considered to be inadequately responding to oral or parenteral MTX therapy for ≥3 months and \<10 years prior to screening and to be tolerating a dose of 15 to 25 mg per week. Participants should also be on a stable dose of folic acid (or equivalent).
•4. Except for MTX, must have discontinued all oral DMARDs prior to baseline visit.
•5. If participants are taking NSAIDs or acetaminophen for stable medical conditions, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit and the doses of the medications should be kept stable throughout the study.
•6. If participants are taking oral corticosteroids (equivalent to prednisolone ≤10 mg), or inhaled corticosteroids, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions.

Exclusion Criteria

•1. Abnormality in the 12-lead ECG, heart rate or blood pressure at screening.
•2. Any clinically significant neurological, GI, renal, hepatic, CV, psychiatric, respiratory, metabolic, endocrine, haematological, ophthalmic, or other major disorder which, in the opinion of the Investigator, would put the participant at risk by participating in the study.
•3. Any current malignancy or a history of malignancy within 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
•4. Any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
•5. Active infection that is clinically significant in the Investigator's opinion, or any infection requiring hospitalisation or treatment with intravenous antimicrobials ≤60 days of screening, or any infection requiring oral antimicrobial therapy ≤2 weeks of the baseline visit.
•6. Clinically significant features of arthroses that could interfer with study assessments and objectives.

Locations (46)

Site 1201 - Univerzitetski Klinicki Centar Republike Srpske

Banja Luka, Bosnia and Herzegovina

Site 1204 - Univerzitetski Klinicki Centar Republike Srpske

Banja Luka, Bosnia and Herzegovina

Site 1202 - General Hospital Gradiška

Gradiška, Bosnia and Herzegovina

Site 1308 - Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Site 1302 - Medical Center Artmed OOD

Plovdiv, Bulgaria

Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria

Site 1306 - Diagnostic- Consultative Center Convex EOOD

Sofia, Bulgaria

Site 1307 - Medical Center Excelsior OOD - PPDS

Sofia, Bulgaria

Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, Bulgaria

Site 1304 - Medical Center Leo Clinic EOOD, Varna

Varna, Bulgaria

Key Dates

Start Date

August 29, 2022

Primary Completion Date

December 28, 2023

Completion Date

January 3, 2024

Last Updated

April 24, 2025

Enrollment

248

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

MBS2320 5 mg

DRUG

MBS2320 20 mg

DRUG

MBS2320 40 mg

DRUG

Placebo

DRUG

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Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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