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

NCT ID: NCT05460832

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2024-01-03

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral capsule

MBS2320 5 mg

Group Type: EXPERIMENTAL

MBS2320 5 mg

Intervention Type: DRUG

Oral capsule

MBS2320 20 mg

Group Type: EXPERIMENTAL

MBS2320 20 mg

Intervention Type: DRUG

Oral capsule

MBS2320 40 mg

Group Type: EXPERIMENTAL

MBS2320 40 mg

Intervention Type: DRUG

Oral capsule

Interventions

MBS2320 5 mg

Oral capsule

Intervention Type: DRUG

MBS2320 20 mg

Oral capsule

Intervention Type: DRUG

MBS2320 40 mg

Oral capsule

Intervention Type: DRUG

Placebo

Oral capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Modern Biosciences Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

IST-06 IST-06

Role: STUDY_DIRECTOR

Modern Biosciences Ltd

Locations

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

Site 2103 - Enroll SpA - PPDS

Providencia, , Chile

Site 2105 - CTR Estudios

Providencia, , Chile

Site 2104 - Meditek Ltda

Santiago, , Chile

Site 2106 - Biocinetic SpA

Santiago, , Chile

Site 2107 - Hospital Dr Sotero Del Rio

Santiago, , Chile

Site 2102 - Clinical Research Chile SpA - PPDS

Valdivia, , Chile

Site 2101 - Oncocentro APYS

Viña del Mar, , Chile

Site 1104 - CCR Ostrava s.r.o.

Ostrava, , Czechia

Site 1101 - CCR Czech

Pardubice, , Czechia

Site 1103 - CLINTRIAL s.r.o.

Prague, , Czechia

Site 1102 - MEDICAL PLUS, s.r.o.

Uherské Hradište, , Czechia

Site 2401 - Clinica Medica Con Especialidad Reumatologia

Guatemala City, , Guatemala

Site 2402 - Clinica Medica Especializada en Reumatologia

Guatemala City, , Guatemala

Site 2404 - Reumacentro

Guatemala City, , Guatemala

Site 2405 - Hospital Herrera Llerandi

Guatemala City, , Guatemala

Site 2406 - Clinica Medica Especializada en Medicina Interna

Guatemala City, , Guatemala

Site 2206 - Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

Burócratas del Estado, , Mexico

Site 2203 - Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, , Mexico

Site 2202 - Morales Vargas Centro de Investigacion SC

León, , Mexico

Site 2201 - Centro de Investigación en Artritis y Osteoporosis - PPDS

Mexicali, , Mexico

Site 2205 - Biológicos Especializados S.A. de C.V.

Mexico City, , Mexico

Site 2204 - Centro de Investigación y Tratamiento Reumatológico S.C

Miguel Hidalgo, , Mexico

Site 1006 - ClinicMed Daniluk, Nowak Spółka Jawna

Bialystok, , Poland

Site 1002 - MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, , Poland

Site 1009 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Site 1007 - NZOZ Lecznica MAK-MED

Nadarzyn, , Poland

Site 1004 -Twoja Przychodnia NCM

Nowa Sól, , Poland

Site 1001 - ETYKA Osrodek Badan Klinicznych

Olsztyn, , Poland

Site 1003 - Centrum Medyczne Reuma Park NZOZ

Warsaw, , Poland

Site 1008 - Centrum Medyczne AMED

Warsaw, , Poland

Site 1402 - Institute of Rheumatology Belgrade - PPDS

Belgrade, , Serbia

Site 1403 - Institute of Rheumatology Belgrade - PPDS

Belgrade, , Serbia

Site 1404 - Military Medical Academy

Belgrade, , Serbia

Site 1405 - Institute of Rheumatology Belgrade - PPDS

Belgrade, , Serbia

Site 1406 - Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, , Serbia

Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad

Novi Sad, , Serbia

Countries

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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-005496-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IST-06

Identifier Type: -

Identifier Source: org_study_id