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

NCT05460832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-04-24

Study results available
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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

Interventions

DRUG

MBS2320 5 mg

Oral capsule

DRUG

MBS2320 20 mg

Oral capsule

DRUG

MBS2320 40 mg

Oral capsule

DRUG

Placebo

Oral capsule

Sponsors & Collaborators

  • Modern Biosciences Ltd

    lead INDUSTRY

Principal Investigators

  • IST-06 IST-06 · Modern Biosciences Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-29
Primary Completion
2023-12-28
Completion
2024-01-03

Countries

  • Bosnia and Herzegovina
  • Bulgaria
  • Chile
  • Czechia
  • Guatemala
  • Mexico
  • Poland
  • Serbia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05460832 on ClinicalTrials.gov