Clinical trial NCT05460832: Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis (RA)
MBS2320
Lead sponsor: Modern Biosciences Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

This list contains only key inclusion criteria.

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.

This list contains only key exclusion criteria.

Primary outcomes:
measure: Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)
timeFrame: Week 12
Secondary outcomes:
measure: Safety and Tolerability of MBS2320
timeFrame: Week 12
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Site 1201 - Univerzitetski Klinicki Centar Republike Srpske
city: Banja Luka
country: Bosnia and Herzegovina
facility: Site 1204 - Univerzitetski Klinicki Centar Republike Srpske
city: Gradiška
country: Bosnia and Herzegovina
facility: Site 1202 - General Hospital Gradiška
city: Pleven
country: Bulgaria
facility: Site 1308 - Medical Center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: Site 1302 - Medical Center Artmed OOD
city: Sofia
country: Bulgaria
facility: Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: Site 1306 - Diagnostic- Consultative Center Convex EOOD
city: Sofia
country: Bulgaria
facility: Site 1307 - Medical Center Excelsior OOD - PPDS
city: Stara Zagora
country: Bulgaria
facility: Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
city: Varna
country: Bulgaria
facility: Site 1304 - Medical Center Leo Clinic EOOD, Varna
city: Providencia
country: Chile
facility: Site 2103 - Enroll SpA - PPDS
city: Providencia
country: Chile
facility: Site 2105 - CTR Estudios
city: Santiago
country: Chile
facility: Site 2104 - Meditek Ltda
city: Santiago
country: Chile
facility: Site 2106 - Biocinetic SpA
city: Santiago
country: Chile
facility: Site 2107 - Hospital Dr Sotero Del Rio
city: Valdivia
country: Chile
facility: Site 2102 - Clinical Research Chile SpA - PPDS
city: Viña del Mar
country: Chile
facility: Site 2101 - Oncocentro APYS
city: Ostrava
country: Czechia
facility: Site 1104 - CCR Ostrava s.r.o.
city: Pardubice
country: Czechia
facility: Site 1101 - CCR Czech
city: Prague
country: Czechia
facility: Site 1103 - CLINTRIAL s.r.o.
city: Uherské Hradište
country: Czechia
facility: Site 1102 - MEDICAL PLUS, s.r.o.
city: Guatemala
country: Guatemala
facility: Site 2401 - Clinica Medica Con Especialidad Reumatologia
city: Guatemala
country: Guatemala
facility: Site 2402 - Clinica Medica Especializada en Reumatologia
city: Guatemala
country: Guatemala
facility: Site 2404 - Reumacentro
city: Guatemala
country: Guatemala
facility: Site 2405 - Hospital Herrera Llerandi
city: Guatemala
country: Guatemala
facility: Site 2406 - Clinica Medica Especializada en Medicina Interna
city: Burócratas del Estado
country: Mexico
facility: Site 2206 - Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
city: Guadalajara
country: Mexico
facility: Site 2203 - Centro de Estudios de Investigacion Basica Y Clinica SC
city: León
country: Mexico
facility: Site 2202 - Morales Vargas Centro de Investigacion SC
city: Mexicali
country: Mexico
facility: Site 2201 - Centro de Investigación en Artritis y Osteoporosis - PPDS
city: Mexico City
country: Mexico
facility: Site 2205 - Biológicos Especializados S.A. de C.V.
city: Miguel Hidalgo
country: Mexico
facility: Site 2204 - Centro de Investigación y Tratamiento Reumatológico S.C
city: Bialystok
country: Poland
facility: Site 1006 - ClinicMed Daniluk, Nowak Spółka Jawna
city: Bydgoszcz
country: Poland
facility: Site 1002 - MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Site 1009 - Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Nadarzyn
country: Poland
facility: Site 1007 - NZOZ Lecznica MAK-MED
city: Nowa Sól
country: Poland
facility: Site 1004 -Twoja Przychodnia NCM
city: Olsztyn
country: Poland
facility: Site 1001 - ETYKA Osrodek Badan Klinicznych
city: Warszawa
country: Poland
facility: Site 1003 - Centrum Medyczne Reuma Park NZOZ
city: Warszawa
country: Poland
facility: Site 1008 - Centrum Medyczne AMED
city: Belgrade
country: Serbia
facility: Site 1402 - Institute of Rheumatology Belgrade - PPDS
city: Belgrade
country: Serbia
facility: Site 1403 - Institute of Rheumatology Belgrade - PPDS
city: Belgrade
country: Serbia
facility: Site 1404 - Military Medical Academy
city: Belgrade
country: Serbia
facility: Site 1405 - Institute of Rheumatology Belgrade - PPDS
city: Niška Banja
country: Serbia
facility: Site 1406 - Institute for Treatment and Rehabilitation Niska Banja
city: Novi Sad
country: Serbia
facility: Site 1401 - Special Hospital For Rheumatic Diseases Novi Sad
Study officials:
affiliation: Modern Biosciences Ltd
name: IST-06 IST-06
role: STUDY_DIRECTOR
References: