Actively Recruiting
A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis
Led by Mage Biologics · Updated on 2026-04-14
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MB-001, an oral biologic medication, as a treatment for adults with moderately to severely active ulcerative colitis. This double-blind, placebo-controlled clinical trial aims to assess the safety and effectiveness of MB-001 compared to a matching placebo. The study also investigates endoscopic and histological responses, as well as pharmacokinetics and pharmacodynamic changes. The trial is sponsored by Mage Biologics and includes participants aged 18 to 75 years. Participants will take either MB-001 or a matching placebo capsule once daily for 12 weeks during the double-blind phase. Following this, those completing the initial phase may enter an open-label extension lasting another 12 weeks where all participants receive the active treatment. The study includes up to nine clinic visits and daily symptom diaries to monitor the participant's condition throughout the treatment and extension phases. During the study, participants will undergo clinical symptom evaluations, laboratory tests, and endoscopic examinations to measure outcomes such as clinical remission, endoscopic improvement, and histologic remission. Researchers will monitor adverse events and laboratory parameters like blood cell counts and liver function until four weeks after treatment ends. The total involvement for participants can last up to 24 weeks, including both study phases and follow-up assessments.
CONDITIONS
Brief 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, confirmed by clinical, endoscopic, and histological evidence at least 3 months before screening
- Moderately to severely active ulcerative colitis with specific activity scores (mMS 5-9, MES ≥ 2, RB subscore ≥ 1)
- Required colonoscopy or flexible sigmoidoscopy based on disease duration and prior examinations
- Inadequate response, loss of response, or intolerance to at least one approved UC treatment including 5-ASA, corticosteroids, immunosuppressants, anti-integrin, anti-IL-12/23, anti-IL-23 p19 antibodies, or S1PR modulators
- Stable or stopped doses of certain UC medications before screening endoscopy
- Women of childbearing potential must use acceptable contraception and have a negative pregnancy test before dosing
- Ability to fully participate and provide informed consent
You will not qualify if you...
- Acute severe ulcerative colitis or recent hospitalization for UC treatment
- Previous extensive colon surgery or conditions like short bowel syndrome, ileostomy, colostomy, or bowel stenosis
- Toxic megacolon or recent history of bowel perforation
- Diagnoses other than ulcerative colitis such as Crohn's disease, indeterminate colitis, ischemic or infectious colitis
- Uncontrolled liver disease or primary sclerosing cholangitis
- Recent or history of malignancy within 5 years (with some exceptions)
- History of lymphoproliferative disease or significant cardiovascular morbidity
- Abnormal vital signs, ECG abnormalities related to QT prolongation, or bleeding disorders
- Major neurological disorders or increased risk of infections including positive TB or hepatitis tests
- Autoimmune disorders requiring immunosuppressants
- Certain laboratory abnormalities outside defined limits
- Inadequate response to multiple advanced UC therapies
- Recent use of biologics, S1PR modulators, IV antibiotics, rectal therapies, NSAIDs, or medications affecting peristalsis
- Recent fecal microbiota transplant or live vaccinations
- Recent major surgery or participation in another investigational trial
- History of substance abuse or allergy to study drug
- Conditions limiting study participation such as mandatory military service or judicial restrictions
- Immediate family or dependent relationships with study staff
- Other severe medical or psychiatric conditions that increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral capsules of MB-001 or matching placebo to treat moderately to severely active ulcerative colitis.
Weekly visits for up to 12 weeks
Duration - 4 weeks
Participants are monitored for safety and treatment effects for 4 weeks after treatment ends.
1 to 2 visits depending on safety assessments
Trial Site Locations
Total: 1 location
1
Site 3001
Chisinau, Moldova
Actively Recruiting
Research Team
J
Johannes Spleiss, MSc
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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