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

NCT05460832 | Completed Phase 2 Results

• 2 other identifiers: IST-062020-005496-13
• Study Type: interventional
• Target: 248
• Locations: 8 countries
• Sites: 46

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

Keywords

Rheumatoid Arthritis (RA); MBS2320

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)

  Achieving clinical response according to the criteria for ACR20: * ≥20% improvement in 68-Tender Joint Count; * ≥20% improvement in 66-SJC; and * ≥20% improvement in at least 3 of the 5 following parameters: 1. Physician's global assessment of disease activity 2. Participant's global assessment of disease activity 3. Participant's assessment of arthritis pain 4. Health Assessment Questionnaire - Disability Index (HAQ-DI) 5. High-sensitivity C-reactive protein (hsCRP)

  Week 12

Secondary Outcomes (1)

• Safety and Tolerability of MBS2320

  Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MBS2320 5 mg

EXPERIMENTAL

Drug: MBS2320 5 mg

MBS2320 20 mg

EXPERIMENTAL

Drug: MBS2320 20 mg

MBS2320 40 mg

EXPERIMENTAL

Drug: MBS2320 40 mg

Interventions

MBS2320 5 mg DRUG

Oral capsule

MBS2320 5 mg

MBS2320 20 mg DRUG

Oral capsule

MBS2320 20 mg

MBS2320 40 mg DRUG

Oral capsule

MBS2320 40 mg

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR criteria for ≥3 months prior to screening.
• 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)
• 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).
• Except for MTX, must have discontinued all oral DMARDs prior to baseline visit.
• 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.
• 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.

You may not qualify if:

• Abnormality in the 12-lead ECG, heart rate or blood pressure at screening.
• 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.
• 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.
• Any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
• 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.
• Clinically significant features of arthroses that could interfer with study assessments and objectives.

Sponsors & Collaborators

• Modern Biosciences Ltd: lead

Study Sites (46)

Site 1201 - Univerzitetski Klinicki Centar Republike Srpske

Banja Luka, Bosnia and Herzegovina

Location

Site 1204 - Univerzitetski Klinicki Centar Republike Srpske

Banja Luka, Bosnia and Herzegovina

Location

Site 1202 - General Hospital Gradiška

Gradiška, Bosnia and Herzegovina

Location

Site 1308 - Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Location

Site 1302 - Medical Center Artmed OOD

Plovdiv, Bulgaria

Location

Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria

Location

Site 1306 - Diagnostic- Consultative Center Convex EOOD

Sofia, Bulgaria

Location

Site 1307 - Medical Center Excelsior OOD - PPDS

Sofia, Bulgaria

Location

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

Stara Zagora, Bulgaria

Location

Site 1304 - Medical Center Leo Clinic EOOD, Varna

Varna, Bulgaria

Location

Site 2103 - Enroll SpA - PPDS

Providencia, Chile

Location

Site 2105 - CTR Estudios

Providencia, Chile

Location

Site 2104 - Meditek Ltda

Santiago, Chile

Location

Site 2106 - Biocinetic SpA

Santiago, Chile

Location

Site 2107 - Hospital Dr Sotero Del Rio

Santiago, Chile

Location

Site 2102 - Clinical Research Chile SpA - PPDS

Valdivia, Chile

Location

Site 2101 - Oncocentro APYS

Viña del Mar, Chile

Location

Site 1104 - CCR Ostrava s.r.o.

Ostrava, Czechia

Location

Site 1101 - CCR Czech

Pardubice, Czechia

Location

Site 1103 - CLINTRIAL s.r.o.

Prague, Czechia

Location

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

Uherské Hradište, Czechia

Location

Site 2401 - Clinica Medica Con Especialidad Reumatologia

Guatemala City, Guatemala

Location

Site 2402 - Clinica Medica Especializada en Reumatologia

Guatemala City, Guatemala

Location

Site 2404 - Reumacentro

Guatemala City, Guatemala

Location

Site 2405 - Hospital Herrera Llerandi

Guatemala City, Guatemala

Location

Site 2406 - Clinica Medica Especializada en Medicina Interna

Guatemala City, Guatemala

Location

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

Burócratas del Estado, Mexico

Location

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

Guadalajara, Mexico

Location

Site 2202 - Morales Vargas Centro de Investigacion SC

León, Mexico

Location

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

Mexicali, Mexico

Location

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

Mexico City, Mexico

Location

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

Miguel Hidalgo, Mexico

Location

Site 1006 - ClinicMed Daniluk, Nowak Spółka Jawna

Bialystok, Poland

Location

Site 1002 - MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Location

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

Bydgoszcz, Poland

Location

Site 1007 - NZOZ Lecznica MAK-MED

Nadarzyn, Poland

Location

Site 1004 -Twoja Przychodnia NCM

Nowa Sól, Poland

Location

Site 1001 - ETYKA Osrodek Badan Klinicznych

Olsztyn, Poland

Location

Site 1003 - Centrum Medyczne Reuma Park NZOZ

Warsaw, Poland

Location

Site 1008 - Centrum Medyczne AMED

Warsaw, Poland

Location

Site 1402 - Institute of Rheumatology Belgrade - PPDS

Belgrade, Serbia

Location

Site 1403 - Institute of Rheumatology Belgrade - PPDS

Belgrade, Serbia

Location

Site 1404 - Military Medical Academy

Belgrade, Serbia

Location

Site 1405 - Institute of Rheumatology Belgrade - PPDS

Belgrade, Serbia

Location

Site 1406 - Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, Serbia

Location

Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad

Novi Sad, Serbia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Modern Biosciences

IST-06@istesso.co.uk

+44 (0) 207 444 0066

Study Officials

• IST-06 IST-06

  Modern Biosciences Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: August 29, 2022
• Primary Completion: December 28, 2023
• Study Completion: January 3, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GU (5); BO (3); SE (6); ME (6); CL (7); CZ (4); PL (8); BU (7)