A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

NCT06582264 | Completed Phase 1

• 2 other identifiers: MB310-012023-507376-50
• Study Type: interventional
• Target: 29
• Locations: 4 countries
• Sites: 18

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Percentage of patients achieving clinical remission at Day 91

  Day 91

• Percentage of patients achieving steroid-free remission at Day 91

  Day 91

• Percentage of patients achieving persistent steroid-free remission at Day 91

  Day 64 to Day 91

• Percentage of patients achieving clinical response at Day 91

  Day 91

• Percentage of patients achieving endoscopic improvement at Day 91

  Day 91

Study Arms (2)

Vancomycin preconditioning followed by MB310

EXPERIMENTAL

Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks

Biological: MB310; Drug: Vancomycin

Vancomycin preconditioning followed by Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Drug: Vancomycin

Interventions

MB310 BIOLOGICAL

Live bacterial therapeutic for oral administration

Vancomycin preconditioning followed by MB310

Vancomycin DRUG

Antibiotic

Vancomycin preconditioning followed by MB310; Vancomycin preconditioning followed by Placebo

Placebo OTHER

MB310-matching placebo for oral administration

Vancomycin preconditioning followed by Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• Severe/fulminant UC;
• 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;
• 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;

Sponsors & Collaborators

• Microbiotica Ltd: lead

Study Sites (18)

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Location

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Austria

Location

Uniklinikum Salzburg

Salzburg, Austria

Location

Medizinische Universitaet Wien

Vienna, Austria

Location

Acibadem City Clinic, Tokuda Hospital

Sofia, Bulgaria

Location

Diagnostic Consulting Center Convex EOOD

Sofia, Bulgaria

Location

Medical Center Rusemed EOOD

Sofia, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Stara Zagora, Bulgaria

Location

Diagnostic-Consulting Center

Varna, Bulgaria

Location

Centrum Medyczne Kermed

Bydgoszcz, Poland

Location

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

Location

Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych

Warsaw, Poland

Location

Warsaw IBD Point

Warsaw, Poland

Location

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych

Warsaw, Poland

Location

University Hospital Birmingham

Birmingham, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 3, 2024
• Study Start: September 27, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

AU (4); PL (5); GB (4); BU (5)