A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Live bacterial therapeutic for oral administration
MB310-matching placebo for oral administration
Antibiotic
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Klinikum Klagenfurt am Woerthersee
Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs
Time frame: 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
Time frame: 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
Time frame: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)
Percentage of patients achieving clinical remission at Day 91
Clinical remission defined as a Modified Mayo Score (MMS) 0 to 2 with endoscopic subscore of 0 or 1
Time frame: Day 91
Percentage of patients achieving steroid-free remission at Day 91
No steroid exposure at Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1
Time frame: Day 91
Percentage of patients achieving persistent steroid-free remission at 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
Time frame: Day 64 to Day 91
Percentage of patients achieving clinical response at 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
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Klagenfurt, Austria
Uniklinikum Salzburg
Salzburg, Austria
Medizinische Universitaet Wien
Vienna, Austria
Acibadem City Clinic, Tokuda Hospital
Sofia, Bulgaria
Diagnostic Consulting Center Convex EOOD
Sofia, Bulgaria
Medical Center Rusemed EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment
Stara Zagora, Bulgaria
Diagnostic-Consulting Center
Varna, Bulgaria
Centrum Medyczne Kermed
Bydgoszcz, Poland
...and 12 more locations
Time frame: Day 91
Percentage of patients achieving endoscopic improvement at Day 91
Endoscopic improvement is defined as a decrease in MMS endoscopic subscore by 1 or more point from baseline
Time frame: Day 91
Percentage of patients who achieve clinical improvement at Day 64 (Visit 10) and Day 91 (Visit 11)
Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline
Time frame: Day 91
Time to clinical improvement
Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline
Time frame: End of Follow-Up (12 weeks after the last dose of study treatment)
Engraftment of MB310 bacteria into patients' intestinal microbial community
Measurement of MB310 strain colonisation in stool samples using a qPCR-based approach.
Time frame: Up to End of Follow-Up (12 weeks after the last dose of study treatment)