Evaluating the safety of MB310 for treating mild-to-moderate ulcerative colitis

A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

This study is testing a new medication called MB310 to see if it's safe for people with mild-to-moderate ulcerative colitis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Microbiotica Ltd (Industry-sponsored)
• Drugs / interventions: tofacitinib, filgotinib, upadacitinib
• Locations: 18 sites (Innsbruck and 17 other locations)
• Trial ID: NCT06582264 on ClinicalTrials.gov

What this trial studies

This Phase 1b trial assesses the safety and tolerability of MB310 in patients diagnosed with active mild-to-moderate ulcerative colitis. Participants will receive either MB310 or a placebo, with the study focusing on those who meet specific clinical criteria for ulcerative colitis severity. The trial aims to gather data on the drug's effects and safety profile in this patient population. The study will involve clinical assessments and monitoring of participants throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed or recurrent mild-to-moderate ulcerative colitis.

Not a fit: Patients with severe ulcerative colitis or those who do not meet the specific clinical criteria for inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from mild-to-moderate ulcerative colitis.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for ulcerative colitis have shown promise in the past.

Eligibility criteria

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 exclusion criteria include but are not limited to the following:

* 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;
  * 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.
* Patients whose disease has not responded to or lost response to 2 or more advanced therapies (biologics or small molecules);
* Significant liver impairment;
* Concurrent primary sclerosing cholangitis;
* Clinically significant hematological function abnormalities;
* Known hypersensitivity, intolerance, or contraindication to oral vancomycin, MB310, and/or any excipients;
* 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);
* Any infectious disease (HIV is allowed where certain protocol-specified criteria are met);
* Significant cardiovascular condition;
* 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
* Any other clinically relevant or poorly controlled, unstable condition that would confound study endpoints or adversely affect patient safety or compliance.

Where this trial is running

Innsbruck and 17 other locations

• Medizinische Universitaet Innsbruck — Innsbruck, Austria (Recruiting)
• Klinikum Klagenfurt am Woerthersee — Klagenfurt, Austria (Recruiting)
• Uniklinikum Salzburg — Salzburg, Austria (Recruiting)
• Medizinische Universitaet Wien — Wien, Austria (Recruiting)
• Acibadem City Clinic, Tokuda Hospital — Sofia, Bulgaria (Recruiting)
• Diagnostic Consulting Center Convex EOOD — Sofia, Bulgaria (Recruiting)
• Medical Center Rusemed EOOD — Sofia, Bulgaria (Recruiting)
• University Multiprofile Hospital for Active Treatment — Stara Zagora, Bulgaria (Recruiting)
• Diagnostic-Consulting Center — Varna, Bulgaria (Recruiting)
• Centrum Medyczne Kermed — Bydgoszcz, Poland (Recruiting)
• Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland (Recruiting)
• Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych — Warszawa, Poland (Recruiting)
• Warsaw IBD Point — Warszawa, Poland (Recruiting)
• Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych — Warszawa, Poland (Recruiting)
• University Hospital Birmingham — Birmingham, United Kingdom (Recruiting)
• Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
• St George's Hospital — London, United Kingdom (Recruiting)
• Royal Victoria Infirmary — Newcastle, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Clinical Development Team

Conditions Ulcerative Colitis