Trial Outcomes & Findings for Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (NCT NCT05460832)
NCT ID: NCT05460832
Last Updated: 2025-04-24
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
248 participants
Primary outcome timeframe
Week 12
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Oral capsule
|
MBS2320 5 mg
MBS2320 5 mg: Oral capsule
|
MBS2320 20 mg
MBS2320 20 mg: Oral capsule
|
MBS2320 40 mg
MBS2320 40 mg: Oral capsule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
63
|
61
|
|
Overall Study
COMPLETED
|
57
|
61
|
54
|
57
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
Baseline characteristics by cohort
| Measure |
MBS2320 5 mg
n=62 Participants
MBS2320 5 mg once daily for 12 weeks
|
MBS2320 20 mg
n=63 Participants
MBS2320 20 mg once daily for 12 weeks
|
MBS2320 40 mg
n=61 Participants
MBS2320 40 mg once daily for 12 weeks
|
Placebo
n=62 Participants
Matching placebo capsules were provided containing the same excipients as the MBS2320 capsules but minus the active drug. The dosing instructions were the same as for MBS2320.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
209 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
55.0 Years
STANDARD_DEVIATION 12.48 • n=7 Participants
|
53.0 Years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
55.5 Years
STANDARD_DEVIATION 11.42 • n=4 Participants
|
55.0 Years
STANDARD_DEVIATION 12.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
213 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Achieving 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)
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Oral capsule
|
MBS2320 5 mg
n=62 Participants
MBS2320 5 mg: Oral capsule
|
MBS2320 20 mg
n=63 Participants
MBS2320 20 mg: Oral capsule
|
MBS2320 40 mg
n=61 Participants
MBS2320 40 mg: Oral capsule
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)
|
48.4 percentage of patients
|
49.2 percentage of patients
|
42.4 percentage of patients
|
57.7 percentage of patients
|
SECONDARY outcome
Timeframe: Week 12Incidence of all grade adverse events
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MBS2320 5 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MBS2320 20 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MBS2320 40 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=62 participants at risk
Placebo: Oral capsule
|
MBS2320 5 mg
n=62 participants at risk
MBS2320 5 mg: Oral capsule
|
MBS2320 20 mg
n=63 participants at risk
MBS2320 20 mg: Oral capsule
|
MBS2320 40 mg
n=61 participants at risk
MBS2320 40 mg: Oral capsule
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/63 • Through study completion, a period of 12 weeks.
|
1.6%
1/61 • Number of events 1 • Through study completion, a period of 12 weeks.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/63 • Through study completion, a period of 12 weeks.
|
1.6%
1/61 • Number of events 1 • Through study completion, a period of 12 weeks.
|
Other adverse events
| Measure |
Placebo
n=62 participants at risk
Placebo: Oral capsule
|
MBS2320 5 mg
n=62 participants at risk
MBS2320 5 mg: Oral capsule
|
MBS2320 20 mg
n=63 participants at risk
MBS2320 20 mg: Oral capsule
|
MBS2320 40 mg
n=61 participants at risk
MBS2320 40 mg: Oral capsule
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
6.5%
4/62 • Number of events 4 • Through study completion, a period of 12 weeks.
|
6.5%
4/62 • Number of events 4 • Through study completion, a period of 12 weeks.
|
6.3%
4/63 • Number of events 4 • Through study completion, a period of 12 weeks.
|
0.00%
0/61 • Through study completion, a period of 12 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/63 • Through study completion, a period of 12 weeks.
|
6.6%
4/61 • Number of events 4 • Through study completion, a period of 12 weeks.
|
|
Investigations
Blood bicarbonate decreased
|
6.5%
4/62 • Number of events 4 • Through study completion, a period of 12 weeks.
|
6.5%
4/62 • Number of events 4 • Through study completion, a period of 12 weeks.
|
6.3%
4/63 • Number of events 4 • Through study completion, a period of 12 weeks.
|
0.00%
0/61 • Through study completion, a period of 12 weeks.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
12.9%
8/62 • Number of events 8 • Through study completion, a period of 12 weeks.
|
0.00%
0/63 • Through study completion, a period of 12 weeks.
|
8.2%
5/61 • Number of events 5 • Through study completion, a period of 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/62 • Through study completion, a period of 12 weeks.
|
0.00%
0/63 • Through study completion, a period of 12 weeks.
|
6.6%
4/61 • Number of events 4 • Through study completion, a period of 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Trial Agreement
- Publication restrictions are in place
Restriction type: OTHER