NCT05460832

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Modern Biosciences Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MBS2320 5 mg	Oral capsule
DRUG	MBS2320 20 mg	Oral capsule
DRUG	MBS2320 40 mg	Oral capsule
DRUG	Placebo	Oral capsule

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-12-28
• Completion: 2024-01-03
• First posted: 2022-07-15
• Last updated: 2025-04-24
• Results posted: 2025-04-24

Locations

46 sites across 8 countries: Bosnia and Herzegovina, Bulgaria, Chile, Czechia, Guatemala, Mexico, Poland, Serbia