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Study identifier: NCT05460832 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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

Condition: Rheumatoid Arthritis  ·  Sponsor: Modern Biosciences Ltd

PhasePhase 2
Planned participants248
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (46)

Site 1201 - Univerzitetski Klinicki Centar Republike SrpskeBanja Luka, Bosnia and Herzegovina
Site 1204 - Univerzitetski Klinicki Centar Republike SrpskeBanja Luka, Bosnia and Herzegovina
Site 1202 - General Hospital GradiškaGradiska, Bosnia and Herzegovina
Site 1308 - Medical Center Medconsult Pleven OODPleven, Bulgaria
Site 1302 - Medical Center Artmed OODPlovdiv, Bulgaria
Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOODSofia, Bulgaria
Site 1306 - Diagnostic- Consultative Center Convex EOODSofia, Bulgaria
Site 1307 - Medical Center Excelsior OOD - PPDSSofia, Bulgaria
Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich ADStara Zagora, Bulgaria
Site 1304 - Medical Center Leo Clinic EOOD, VarnaVarna, Bulgaria
Site 2103 - Enroll SpA - PPDSProvidencia, Chile
Site 2105 - CTR EstudiosProvidencia, Chile

+ 34 more locations — full list on the registry record.

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