A Phase 2 Study to Confirm Efficacy and Safety of MH002 in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
Published: 03/27/2026
General Information:
The goal of this study is to asses if MH002 is safe and effective in the treatment of patients with mild to moderate ulcerative colitis who are insufficiently controlled with 5-ASA treatment, and to explore the maintenance of long-term treatment effect.
Eligibility:
Inclusion & Exclusion Criteria:
- Male or female, 16 years of age and above
- Diagnosis of active mild-to-moderate UC at screening as defined by a modified Mayo score 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.
- Receiving a stable dose of Mesalazine
- Not having received prior biological treatment
- Do not have a diagnosis of Crohn's disease or severe UC
- Other study criteria will be reviewed as part of the screening period to confirm eligibility
Study Details:
Study description/explanation of participation:
A total of 204 patients will take part in the study. During a screening period of 4 weeks, you will undergo some exams to assess whether you are eligible for the trial. If you are, a central system will decide which treatment you receive (active treatment MH002 or placebo). Neither your study doctor nor you know whether you receive the investigational treatment or placebo (dummy treatment). You will be in this “double-blind” phase for 12 weeks, after which you can continue for another 40 weeks on MH002 (Open Label Extension, meaning both you and your study doctor know that you are receiving the active treatment) ; a follow-up call and visit will occur 2 and 4 weeks after the last dose of study treatment.
Description of treatment or intervention (mechanism of action):
The treatment that is being tested in this study does not have a name yet, but it is known as MH002. It contains 6 bacteria that normally live inside a healthy human gut. These bacteria are not harmful. They are put inside a capsule that is swallowed. This treatment might help your gut to work better and to reduce your ulcerative colitis symptoms. It is possible that this treatment affects your symptoms when the good bacteria in your digestive system are restored.
Patient Participation Requirements:
You will be asked to complete an e-diary daily, and questionnaires during the study visits regarding your UC disease symptoms. There will be blood and urine sampling, stool collection and a colonoscopy before and after entry into the trial.
Possible risks and side effects:
Although not observed in previous studies, the presence of bacteria in the blood (this is called bacteremia) may be a risk associated with MH002. Bacteria in the blood can occur suddenly, even if you are not participating in this study, due to your ulcerative colitis. If you develop bacteremia you may or may not have symptoms, such as chills. If it is determined that the bacteremia is caused by the study medication, you will be asked to stop taking the study medication. If you develop symptoms, you may receive medical treatment.
Progress to date:
It is not the first time MH002 has been used in people. More than 50 people with inflammatory bowel disease (ulcerative colitis is such a disease) have already taken MH002, and it was found to be safe and well tolerated.