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Low Dose MT-1303 for Ulcerative Colitis
Study Summary
This trial will study a new drug for ulcerative colitis, to see if it is better than placebo and can be used for long-term treatment.
- Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Who is running the clinical trial?
Media Library
- Subjects must have an endoscopic subscore of ≥2 from and evidence of active UC extending ≥15 cm from the anal verge confirmed by a screening colonoscopy.You had a type of treatment called fecal microbiota transplantation (FMT) within the last year before the screening visit.You are taking medication for UC, except for oral or rectal 5-ASAs or low-dose oral corticosteroids.You have used enemas or suppositories (except for a constant dose of 5-ASA) to treat your ulcerative colitis within 2 weeks before the screening visit.Subjects who complete the Double-Blind Period of the study who, in the opinion of the Investigator, would benefit from continued treatment, may participate in the Open Label Extension (OLE) Period.You recently had a heart attack, stroke, or heart failure that required hospitalization, or have heart conditions such as abnormal heart rate, rhythm or electrical activity that may be dangerous.If you are taking certain medications (5-ASAs or low dose oral corticosteroids) for UC, you must have been taking the same dose for at least 28 days before being eligible for the study.You have been taking inconsistent amounts of probiotics or diarrhea medication within the two weeks leading up to the screening visit.If you are taking medication for your ulcerative colitis, such as 5-aminosalicylates or corticosteroids, you must have been using a stable dose for at least 28 days before the study.
- Group 1: Low Dose
- Group 2: High Dose
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there many research groups participating in this trial across America?
"To participate in this trial, it is ideal to choose the enrolling location nearest you as there are 30 different sites. Some of these include Fort Lauderdale, West Long Branch and San Bernardino. Keep in mind that travelling may be necessary depending on your proximity to these locations."
If a patient is over 50, do they still qualify for the research?
"Eligibility requirements for this trial include being aged 18-75. There are 71 other trials available for patients that fall under the age of 18 and 363 studies for people over 65."
Has MT-1303 been federally sanctioned for use at lower doses?
"Low Dose MT-1303 is currently in Phase 2 of clinical trials. Thus, while there is some evidence supporting its safety, none yet exists to suggest that it is an effective medication."
How many people are currently being treated as part of this research?
"That is correct, the available information indicates that this study is open for enrollment. The listing was created on September 29th 2021 and updated most recently on June 7th 2022. There are 336 total patients needed to be enrolled at 30 different medical facilities."
Are there specific inclusion criteria for this research project?
"Candidates for this clinical trial must have colitis and meet the age criteria of being between 18 to 75 years old. Currently, the study is looking to enroll 336 individuals."
Are we still enrolling individuals for this clinical research?
"The trial is still open and actively recruiting patients, as shown by the clinicaltrials.gov date which was last updated on 6/7/2022. This study was first posted on 9/29/2021 and is looking for approximately 336 people across 30 different sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Bausch Site 024: < 48 hours
Average response time
- < 2 Days
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