Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis (NCT04857112) | Clinical Trial Compass
CompletedPhase 2
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
United States322 participantsStarted 2021-09-29
Plain-language summary
The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with normal vital signs and a diagnosis of active mild ulcerative colitis (UC) (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
* 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.
* If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization.
* 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.
Exclusion Criteria:
* Any of the following: a diagnosis of Crohn's disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease, current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, proctitis (defined as a rectal inflammation within 15 cm from the anal verge), abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation; a history or evidence of any colonic resection or subtotal or total c…
What they're measuring
1
Change from Baseline in the modified Mayo Score at Day 85