Ulcerative Colitis
Conditions
Brief summary
A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.
Interventions
BIOLOGICALMB310
Live bacterial therapeutic for oral administration
OTHERPlacebo
MB310-matching placebo for oral administration
DRUGVancomycin
Antibiotic
Sponsors
Microbiotica Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Must be aged 18 to 70 years, inclusive, at the time of signing informed consent; * Must have newly diagnosed or a history of recurrent UC based on clinical, endoscopic, and histological assessments; * Must have active, mild-to-moderate UC as defined by the Modified Mayo Score (MMS) of ≥4 and ≤7, and an Endoscopic Subscore of ≤2 in the most affected area proximally ≥15 cm from anal verge; * Male patients, and female patients of childbearing potential who are at risk of pregnancy, must agree to use a highly effective method of birth control * Female patients must not be pregnant or breastfeeding; * Male patients must agree to abstain from sperm donation; * Must be able to understand and comply with the Protocol requirements; and * Must be willing and able to provide written informed consent at Screening (Visit 1).
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs | From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment) |
| Incidence of treatment-emergent clinically significant changes in laboratory parameters, based on haematology, clinical chemistry, and urinalysis test results | From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment) |
| Incidence of treatment-emergent clinically significant changes in 12-lead ECG parameters, vital signs, and physical examination | From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving clinical remission at Day 91 | Day 91 | Clinical remission defined as a Modified Mayo Score (MMS) 0 to 2 with endoscopic subscore of 0 or 1 |
| Percentage of patients achieving steroid-free remission at Day 91 | Day 91 | No steroid exposure at Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1 |
| Percentage of patients achieving persistent steroid-free remission at Day 91 | Day 64 to Day 91 | No steroid exposure between Day 64 and Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1 |
| Percentage of patients achieving clinical response at Day 91 | Day 91 | Clinical response defined as a decrease in MMS by 2 or more points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of 1 or more or an absolute rectal bleeding subscore of 0 or 1 |
| Percentage of patients achieving endoscopic improvement at Day 91 | Day 91 | Endoscopic improvement is defined as a decrease in MMS endoscopic subscore by 1 or more point from baseline |
| Percentage of patients who achieve clinical improvement at Day 64 (Visit 10) and Day 91 (Visit 11) | Day 91 | Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline |
| Time to clinical improvement | End of Follow-Up (12 weeks after the last dose of study treatment) | Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline |
| Engraftment of MB310 bacteria into patients' intestinal microbial community | Up to End of Follow-Up (12 weeks after the last dose of study treatment) | Measurement of MB310 strain colonisation in stool samples using a qPCR-based approach. |
Countries
Austria, Bulgaria, Poland, Spain, United Kingdom
Outcome results
None listed