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Sphingosine-1-phosphate receptor modulator
Low Dose MT-1303 for Ulcerative Colitis
Phase 2
Recruiting
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Do you have the diagnosis of Ulcerative Colitis?
ANSWER YES if you are NOT taking other medications for Ulcerative Colitis in additional to Mesalamine, Sulfasalazine, Olsalazine, balzalazine or oral corticosteroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 85
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.
Eligible Conditions
- Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 85
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in the modified Mayo Score at Day 85
Secondary study objectives
The change from Baseline in the 2-component Mayo Score at Day 85.
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
The proportion of subjects with endoscopic improvement at Day 85
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)
Group II: High DoseExperimental Treatment1 Intervention
MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo, QD (Day 1-85)
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Who is running the clinical trial?
Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,594 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
3,909 Patients Enrolled for Ulcerative Colitis
John LaheyStudy DirectorBausch Health Americas, Inc.
5 Previous Clinical Trials
1,142 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose
- Group 2: High Dose
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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