Actively Recruiting
A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis
Led by Mage Biologics · Updated on 2026-04-14
100
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if MB-001, an oral biologic, is able to treat patients with ulcerative colitis. Participants will be asked to take MB-001 or a matching placebo once-daily for a period of 12 weeks. Researchers will compare MB-001 to placebo to investigate its effects on clinical symptoms as well as endoscopic and histopathological findings. Patients will be offered open-label extension for another 12 weeks following the double-blind, placebo-controlled part of the study. Participants will keep a daily diary to record their symptoms and will have up to nine clinic visits.
CONDITIONS
Official Title
A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of ulcerative colitis extending 15 cm or more from the anal verge, established at least 3 months prior to screening by clinical and endoscopic evidence and confirmed by histology
- Moderately to severely active ulcerative colitis, defined by a modified Mayo score of 5 to 9, with endoscopic subscore of at least 2 and rectal bleeding subscore of at least 1
- Colonoscopy required if extensive colitis or pancolitis duration > 8 years or left-sided colitis > 12 years and no colonoscopy within 1 year; otherwise, flexible sigmoidoscopy may be used
- Inadequate response, loss of response, or intolerance to at least one approved treatment for UC including oral 5-ASA, corticosteroids, immunosuppressants, anti-integrin antibodies, anti-IL-12/23 antibodies, anti-IL-23 p19 antibodies, or S1PR modulators
- Stable dose or stopped specified UC medications for required periods before screening endoscopy
- Nonpregnant, nonlactating; if of childbearing potential, using acceptable contraception during and 28 days after treatment and negative pregnancy test within 24 hours before first dose
- Willing and able to participate fully and provide informed consent
You will not qualify if you...
- Acute severe ulcerative colitis with defined criteria or imminent hospitalization
- Previous extensive colonic surgery such as subtotal or total colectomy
- Conditions like short bowel syndrome, ileostomy, colostomy, ileoanal pouch, fistulae, or intestinal stenosis
- Recent or current toxic megacolon or bowel perforation
- Diagnoses other than ulcerative colitis, including Crohn's disease, indeterminate colitis, ischemic colitis, NSAID-induced colitis, radiation colitis, microscopic colitis, infectious colitis, colonic dysplasia, or untreated bile acid malabsorption
- Primary sclerosing cholangitis with uncontrolled liver function
- Malignancy within 5 years except certain treated skin or cervical cancers
- History of adenomatous polyps unless removed
- Lymphoproliferative disease or symptoms suggestive of it
- Severe cardiovascular disease (Class III or IV)
- Abnormal vital signs, ECG abnormalities including prolonged QTc, or risk factors for QT prolongation
- History of bleeding disorders
- Major neurological disorders like stroke, epilepsy, demyelinating or neurodegenerative diseases
- Increased risk of infections or immunodeficiency including positive TB, HBV, or HCV tests as defined
- Recent significant infections or history of opportunistic infections
- Autoimmune disorders requiring immunosuppressants
- Laboratory abnormalities beyond specified limits
- Inadequate response to more than one advanced UC therapy
- Recent use of biologics, S1PR modulators, IV antibiotics, rectal UC therapies, NSAIDs, or medications affecting peristalsis
- Participation in another clinical trial with investigational therapy recently
- Prior enrollment in this study with IMP exposure
- Substance abuse interfering with compliance
- Known allergy to IMP or excipients
- Restrictions due to military service, legal issues, or institutionalization
- Close relationship to study staff
- Other severe medical or psychiatric conditions increasing risk or interfering with study conduct
AI-Screening
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Trial Site Locations
Total: 1 location
1
Site 3001
Chisinau, Moldova
Actively Recruiting
Research Team
J
Johannes Spleiss, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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