Rheumatoid ArthritisPhase 2NCT05460832
Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
A Phase 2 study testing MBS2320 5 mg, MBS2320 20 mg and MBS2320 40 mg in people with Rheumatoid Arthritis, run by Modern Biosciences Ltd at 46 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MBS2320 5 mg, MBS2320 20 mg and MBS2320 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 29 Aug 2022to 3 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
- This list contains only key inclusion criteria.
Who cannot join
- 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.
- This list contains only key exclusion criteria.
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
Poland8 sites
Site 1006 - ClinicMed Daniluk, Nowak Spółka Jawna
Bialystok
Site 1002 - MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
Site 1009 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz
Site 1007 - NZOZ Lecznica MAK-MED
Nadarzyn
Site 1004 -Twoja Przychodnia NCM
Nowa Sól
Site 1001 - ETYKA Osrodek Badan Klinicznych
Olsztyn
Site 1003 - Centrum Medyczne Reuma Park NZOZ
Warsaw
Site 1008 - Centrum Medyczne AMED
Warsaw
Bulgaria7 sites
Site 1308 - Medical Center Medconsult Pleven OOD
Pleven
Site 1302 - Medical Center Artmed OOD
Plovdiv
Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia
Site 1306 - Diagnostic- Consultative Center Convex EOOD
Sofia
Site 1307 - Medical Center Excelsior OOD - PPDS
Sofia
Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora
Site 1304 - Medical Center Leo Clinic EOOD, Varna
Varna
Chile7 sites
Site 2103 - Enroll SpA - PPDS
Providencia
Site 2105 - CTR Estudios
Providencia
Site 2104 - Meditek Ltda
Santiago
Site 2106 - Biocinetic SpA
Santiago
Site 2107 - Hospital Dr Sotero Del Rio
Santiago
Site 2102 - Clinical Research Chile SpA - PPDS
Valdivia
Site 2101 - Oncocentro APYS
Viña del Mar
Mexico6 sites
Site 2206 - Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
Burócratas del Estado
Site 2203 - Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara
Site 2202 - Morales Vargas Centro de Investigacion SC
León
Site 2201 - Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali
Site 2205 - Biológicos Especializados S.A. de C.V.
Mexico City
Site 2204 - Centro de Investigación y Tratamiento Reumatológico S.C
Miguel Hidalgo
Serbia6 sites
Site 1402 - Institute of Rheumatology Belgrade - PPDS
Belgrade
Site 1403 - Institute of Rheumatology Belgrade - PPDS
Belgrade
Site 1404 - Military Medical Academy
Belgrade
Site 1405 - Institute of Rheumatology Belgrade - PPDS
Belgrade
Site 1406 - Institute for Treatment and Rehabilitation Niska Banja
Niška Banja
Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad
Guatemala5 sites
Site 2401 - Clinica Medica Con Especialidad Reumatologia
Guatemala City
Site 2402 - Clinica Medica Especializada en Reumatologia
Guatemala City
Site 2404 - Reumacentro
Guatemala City
Site 2405 - Hospital Herrera Llerandi
Guatemala City
Site 2406 - Clinica Medica Especializada en Medicina Interna
Guatemala City
Czechia4 sites
Site 1104 - CCR Ostrava s.r.o.
Ostrava
Site 1101 - CCR Czech
Pardubice
Site 1103 - CLINTRIAL s.r.o.
Prague
Site 1102 - MEDICAL PLUS, s.r.o.
Uherské Hradište
Bosnia and Herzegovina3 sites
Site 1201 - Univerzitetski Klinicki Centar Republike Srpske
Banja Luka
Site 1204 - Univerzitetski Klinicki Centar Republike Srpske
Banja Luka
Site 1202 - General Hospital Gradiška
Gradiska
About this study
Official title: 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
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).
Read more
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
- Being tested
- MBS2320 5 mg, MBS2320 20 mg, MBS2320 40 mg, Placebo
- Keywords
- Rheumatoid Arthritis (RA), MBS2320
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS2320 5 mgDrug
Oral capsule
MBS2320 20 mgDrug
Oral capsule
MBS2320 40 mgDrug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MBS2320 5 mg | Experimental | Not described Receives: Drug: MBS2320 5 mg |
| MBS2320 20 mg | Experimental | Not described Receives: Drug: MBS2320 20 mg |
| MBS2320 40 mg | Experimental | Not described Receives: Drug: MBS2320 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Physician's global assessment of disease activity
- Participant's global assessment of disease activity
- Participant's assessment of arthritis pain
- Health Assessment Questionnaire - Disability Index (HAQ-DI)
- High-sensitivity C-reactive protein (hsCRP)
Measured: Week 12
Secondary outcomes (1)
Safety and Tolerability of MBS2320
Incidence of all grade adverse events
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start29 Aug 2022
- Primary completion28 Dec 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modern Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IST-06 IST-06, Study director, Modern Biosciences Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460832
- Sponsor's protocol ID
- IST-06
- Other IDs
- 2020-005496-13
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2022
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05460832
- Acronym / sponsor ID
- IST-06
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis (RA), MBS2320
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Modern Biosciences LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBS2320 5 mgOral capsule | Drug | MBS2320 5 mg |
| MBS2320 20 mgOral capsule | Drug | MBS2320 20 mg |
| MBS2320 40 mgOral capsule | Drug | MBS2320 40 mg |
| PlaceboOral capsule | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)
Time frame: Week 12
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)
1 secondary outcome
Safety and Tolerability of MBS2320
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IST-06 IST-06 study director
Modern Biosciences Ltd
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBS2320 5 mg, MBS2320 20 mg and MBS2320 40 mg in people with Rheumatoid Arthritis, run by Modern Biosciences Ltd at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Poland, Bulgaria, Chile, Mexico, Serbia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.