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.
This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completing the Double-Blind Period through Day 85 will be provided the opportunity to continue in the OLE Period of the study to receive treatment through approximately one year. Subjects who do not participate in the OLE Period will be followed for 84 days in a Safety Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
322
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)
MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
Matching placebo, QD (Day 1-85)
Change from Baseline in the modified Mayo Score at Day 85
The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The modified Mayo Score is defined as the sum of the endoscopy findings subscore + stool frequency subscore + rectal bleeding subscore, with a range from 0 to 9.
Time frame: Baseline to Day 85
The proportion of subjects with endoscopic improvement at Day 85
The Mayo endoscopic subscore ranges from 0 to 3, with higher scores indicating worse severity. Endoscopic improvement is a Mayo endoscopic subscore of ≤1.
Time frame: Baseline to Day 85
The change from Baseline in the 2-component Mayo Score at Day 85.
2-component Mayo scoring is accomplished by summation of subscores for endoscopic findings and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The 2-component Mayo Score is the sum of the rectal bleeding plus endoscopic subscores, with a range from 0 to 6.
Time frame: Baseline to Day 85
The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score
The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. Remission is defined as follows: * Endoscopy subscore of ≤1 (excludes friability); and * Rectal bleeding subscore of 0; and * At least one-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore of ≤1.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study
Bausch Site 025
Chandler, Arizona, United States
Salix Site 004
Los Angeles, California, United States
Salix Site 003
Rancho Cucamonga, California, United States
Salix Site 007
Rialto, California, United States
Salix Site 006
Ventura, California, United States
Bausch Site 013
Maitland, Florida, United States
Bausch Site 024
Miami, Florida, United States
Salix Site 005
Miramar, Florida, United States
Bausch site 026
Orlando, Florida, United States
Salix Site 010
Snellville, Georgia, United States
...and 175 more locations
Time frame: Baseline to Day 85