Confirmatory Clinical Study in Active Ulcerative Colitis
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 16 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether MH002 is safe and works for people with active, mild to moderate ulcerative colitis, a bowel disease that causes swelling and sores. MH002 is a medicine with live bacteria meant to help the damaged gut work normally again. The study will test two doses and look at long-term treatment effects.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You were diagnosed with ulcerative colitis at least 3 months before screening, with tissue tests and a bowel exam or imaging.
- Your disease is active and mild to moderate, with bleeding and more frequent stools that meet the study’s test scores.
- Your bowel sores extend at least 10 centimeters from the anus.
- You take a steady dose of oral 5-ASA, a medicine for bowel swelling; it did not work well enough; or you cannot tolerate or safely take it.
- You must sign a form agreeing to join. A parent or legal guardian must also give permission for participants under 18, as local rules require.
- If you could become pregnant, you must follow local birth control rules through the end of treatment.
Who can't join
- You have another listed bowel disease, a serious active gut infection, severe ulcerative colitis, disease only in the rectum, disease worst in the middle or right colon, or a planned hospital stay at screening.
- You have had certain major bowel surgeries, colon cancer, or high-risk abnormal colon cells. You have an abnormal passage or pocket of pus in the belly, inflamed bowel pouches, or gut bleeding not caused by ulcerative colitis.
- You have ever used advanced ulcerative colitis treatments, such as biologic medicines or certain medicines that block immune signals.
- You recently used certain medicines: sulfasalazine within 4 weeks, or steroids or immune-changing drugs within 6 weeks before study group assignment. A steady, low dose of oral steroids is allowed under specific study rules.
- You used antibiotics other than local treatments, prebiotics, or probiotics within 4 weeks before study group assignment, or expect to use them during the study; regularly use diarrhea medicine; or use rectal treatments. Recent stool transplants or other experimental treatments also exclude you.
- You have a weakened immune system, certain low blood cell counts, a bleeding disorder, recent or ongoing kidney or serious liver problems, worsening or uncontrolled bone marrow disease, or a past organ or bone marrow transplant.
- You are pregnant or breastfeeding when you join, or have current injected-drug abuse or an alcohol abuse disorder.
- The study doctor finds you unsuitable, or you or a relative work for the study doctor, study site, research organization, or sponsor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening. * Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1. * UC lesions extending ≥10 cm from the anal verge. * Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling. * Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \<18 years of age who has assented to participate in the study, or as required per local regulations). * In countries not allowing females of childbearing potential (FOCBP) to participate without an acceptable contraceptive method, the FOCBP must agree to abide to local requirements and eg, use at least an acceptable method of contraception until the end of treatment. Exclusion Criteria: * Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon. * Evidence of a clinically significant, active infection of the gastrointestinal tract. * Severe UC (mMS\>7), meeting modified Truelove Witts' criteria and/or RB score of 3, participant with ulcerative proctitis only, or participant in whom colitis is most severe in the transverse colon or ascending colon, or if any hospitalization is planned at the time of Screening. * Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon. * Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC. * History of colon carcinoma or high-grade dysplasia. * Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12/23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod). * Use of sulfasalazine ≤4 weeks prior to randomization. * Use of corticosteroids or any disease-modifying antirheumatic drugs (DMARD), including thiopurines, ≤6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (≤10 mg prednisolone/day) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit. * Use of antibiotics (except for local use), prebiotics, or probiotics ≤4 weeks prior to randomization or anticipated during study participation, or concomitant, chronic use of an antidiarrheal drug, or concomitant use of any rectal treatment. * Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization. * Treatment with another investigational drug or intervention within 30 days prior to Screening, or within 5 times the elimination half-life of the investigational drug (whichever is longest). * Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy). * Leukopenia (total white blood cell count \<3000/μL) and/or neutropenia (absolute neutrophil count \<1000/μL), anemia (hemoglobin \<10.0 g/dL), thrombocytopenia (peripheral blood platelet count \<100 × 10\^9/L), and/or any coagulation disorder with significantly increased risk of bleeding. * Ongoing or recent (\<3 months) renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate ≤60 mL/min. * Ongoing or recent (\<3 months) advanced hepatic dysfunction defined as a Child Pugh score ≥10 (Class C), or increase ≥2 times the upper limit of normal in aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) or international normalised ratio (INR). * Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation. * Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator. * Pregnancy or lactation at study entry. Note: Participants who become pregnant or start to breastfeed during the study may continue the study per the Investigator's discretion. * Participants who are inappropriate for the study per the Investigator's discretion. * An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.
Study sites (6)
FL
- ARA Professionals · Miami, FL 33155Sergio Rodriguez · Study contactMore trials in Miami
- Orlando Gastroenterology, P.A. · Orlando, FL 32835Sri Pothamsetty · Study contactMore trials in Orlando
- Tropical Clinical Trials · Palmetto Bay, FL 33176Michael Feldman · Study contactMore trials in Palmetto Bay
NC
- Cross Creek Medical Clinic · Fayetteville, NC 28304Nitinchandra D. Desai · Study contactMore trials in Fayetteville
- Peters Medical Research · High Point, NC 27260Roy Peters · Study contactMore trials in High Point
TX
- Southern Star Research Institute · San Antonio, TX 78229Jeff Bullock · Study contactMore trials in San Antonio