Actively Recruiting
Confirmatory Clinical Study in Active Ulcerative Colitis
Led by MRM Health NV · Updated on 2026-05-14
204
Participants Needed
5
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
CONDITIONS
Official Title
Confirmatory Clinical Study in Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of ulcerative colitis for at least 3 months before screening
- Active mild-to-moderate ulcerative colitis at screening as defined by mMS of 4 to 7, Mayo Endoscopic Subscore 2 or higher, Mayo Rectal Bleeding score of 1 or 2, and Mayo Stool Frequency score 1 or higher
- Ulcerative colitis lesions extending 10 cm or more from the anal verge
- Receiving a stable dose of oral 5-aminosalicylic acid (5-ASA); or have failed 5-ASA due to insufficient efficacy; or have documented intolerance or contraindication to 5-ASA treatment
- Provide written informed consent or assent (with parent or guardian consent for participants under 18)
- Females of childbearing potential must agree to use acceptable contraception as required by local regulations
You will not qualify if you...
- Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon
- Active, clinically significant gastrointestinal infection
- Severe ulcerative colitis (mMS greater than 7) or ulcerative proctitis only
- Colitis most severe in transverse or ascending colon or planned hospitalization at screening
- History of total colectomy, stoma, ileo-anal pouch, or extensive colonic resection leaving less than 30 cm colon
- Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to ulcerative colitis
- History of colon carcinoma or high-grade dysplasia
- Previous use of advanced ulcerative colitis treatments such as anti-TNF, anti-integrin, anti-IL-12/23 or anti-IL23 agents, Janus kinase inhibitors, or sphingosine-1-phosphate receptor modulators
- Use of sulfasalazine within 4 weeks prior to randomization
- Use of corticosteroids or disease-modifying antirheumatic drugs within 6 weeks prior to randomization except stable low-dose corticosteroids
- Use of antibiotics (except local use), prebiotics, probiotics within 4 weeks prior to randomization or during study
- Use of fecal microbiota transplantation within 52 weeks prior to randomization
- Treatment with other investigational drugs within 30 days prior to screening or within 5 times the investigational drug half-life
- Immunocompromised conditions including active HIV, malignancies, liver cirrhosis, or chemotherapy
- Blood disorders such as leukopenia, neutropenia, anemia, thrombocytopenia, or coagulation disorders with high bleeding risk
- Recent or ongoing renal disease or insufficiency within 3 months
- Recent or ongoing advanced liver dysfunction within 3 months
- Significant bone marrow disease or history of organ or bone marrow transplant
- Active intravenous drug or alcohol abuse
- Pregnancy or breastfeeding at study entry
- Participants deemed inappropriate by the investigator
- Employees or relatives of study staff or sponsor
AI-Screening
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Trial Site Locations
Total: 5 locations
1
ARA Professionals
Miami, Florida, United States, 33155
Not Yet Recruiting
2
Tropical Clinical Trials
Palmetto Bay, Florida, United States, 33176
Not Yet Recruiting
3
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States, 28304
Not Yet Recruiting
4
Peters Medical Research
High Point, North Carolina, United States, 27260
Actively Recruiting
5
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jean-Michel Muhlinghaus, DVM
CONTACT
C
Carmen Fleurinck, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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