A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT06582264
- Lead Sponsor
- Microbiotica Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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).
The main exclusion criteria include but are not limited to the following:
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Disease limited to proctitis <15 cm from anal verge;
-
Short bowel or malabsorption syndromes;
-
Prior intestinal or colon resection surgery (with exception of cholecystectomy or appendectomy);
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Severe/fulminant UC;
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Other forms of inflammatory bowel disease including diagnostic uncertainty by the Investigator, or functional gastrointestinal disorders;
-
Positive stool test for parasites, bacterial pathogens, or Clostridium difficile;
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Use of any of the following treatments:
- Oral 5-ASA products at a dose >3.0 g per day (unless the use is currently stable and anticipated to remain stable during the study);
- Aspirin or other nonsteroidal anti-inflammatory drugs (except aspirin for cardioprotective reasons at a dose of ≤325 mg per day);
- Loperamide and other antidiarrheal agents or probiotics;
- Antibiotics or other antibacterial treatment (unless an ophthalmic or otic antibiotic preparation, or a topical antibiotic for skin infection);
- Faecal Matter Transplant (FMT) or administration of Vowst®, Rebiotix®, or other Live Biotherapeutic Product (LBP);
- Intravenous or intramuscular corticosteroids;
- Oral corticosteroids >10 mg prednisolone or equivalent per day;
- Any drugs formulated for rectal administration and/or interventions;
- Immunomodulating or immunosuppressing drugs (unless the use is currently stable and anticipated to remain stable during the study);
- Biologics, ozanimod, etrasimod, tofacitinib, filgotinib, or upadacitinib; or
- Proton pump inhibitors (PPIs) or H2 blockers.
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Patients whose disease has not responded to or lost response to 2 or more advanced therapies (biologics or small molecules);
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Significant liver impairment;
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Concurrent primary sclerosing cholangitis;
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Clinically significant hematological function abnormalities;
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Known hypersensitivity, intolerance, or contraindication to oral vancomycin, MB310, and/or any excipients;
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History of, or known malignancy (unless adequately treated (i.e., cured) basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within 5 years prior to Screening);
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Any infectious disease (HIV is allowed where certain protocol-specified criteria are met);
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Significant cardiovascular condition;
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Involvement in another clinical study (unless observational) within 4 weeks of Screening from the last dose of study drug or 5 half-lives, whichever is longer; or
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Any other clinically relevant or poorly controlled, unstable condition that would confound study endpoints or adversely affect patient safety or compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin preconditioning followed by MB310 MB310 Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks Vancomycin preconditioning followed by MB310 Vancomycin Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks Vancomycin preconditioning followed by Placebo Placebo Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310-matching placebo PO (2 capsules once a day) for 12 weeks Vancomycin preconditioning followed by Placebo Vancomycin Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310-matching placebo PO (2 capsules once a day) for 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (18)
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Klinikum Klagenfurt am Woerthersee
🇦🇹Klagenfurt, Austria
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
Medizinische Universitaet Wien
🇦🇹Wien, Austria
Acibadem City Clinic, Tokuda Hospital
🇧🇬Sofia, Bulgaria
Diagnostic Consulting Center Convex EOOD
🇧🇬Sofia, Bulgaria
Medical Center Rusemed EOOD
🇧🇬Sofia, Bulgaria
Diagnostic-Consulting Center
🇧🇬Varna, Bulgaria
Centrum Medyczne Kermed
🇵🇱Bydgoszcz, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszów, Poland
University Multiprofile Hospital for Active Treatment
🇧🇬Stara Zagora, Bulgaria
Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych
🇵🇱Warszawa, Poland
Warsaw IBD Point
🇵🇱Warszawa, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych
🇵🇱Warszawa, Poland
University Hospital Birmingham
🇬🇧Birmingham, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom