This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
368
Clinical remission at week 8 (Part 1)
The percentage of subjects in clinical remission at week 8.
Time frame: 8 weeks
Clinical remission at week 52 (Part 2)
The percentage of subjects in clinical remission at week 52.
Time frame: 52 weeks
Endoscopic remission at week 8 (Part 1)
The percentage of subjects with endoscopic remission at week 8.
Time frame: 8 weeks
Clinical response at week 8 (Part 1)
The percentage of subjects with clinical response at week 8.
Time frame: 8 weeks
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)
Change from baseline in partial Mayo score at week 2, 4, and 8.
Time frame: 8 weeks
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)
Change in total Mayo score and 9-point modified Mayo score at week 8.
Time frame: 8 weeks
Subjects with endoscopic remission (Part 2)
The percentage of subjects with endoscopic remission at week 52.
Time frame: 52 weeks
Subjects with clinical response at week 52 (Part 2)
The percentage of subjects with clinical response at week 52.
Time frame: 52 weeks
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Digestive Health Specialists
Dothan, Alabama, United States
COMPLETEDOm Research LLC
Lancaster, California, United States
TERMINATEDYale University
New Haven, Connecticut, United States
TERMINATEDIHS Health
Kissimmee, Florida, United States
ACTIVE_NOT_RECRUITINGDade Research Center
Miami, Florida, United States
TERMINATEDGastro Florida
Pinellas Park, Florida, United States
COMPLETEDOne Health Research Clinic Atlanta, LLC
Norcross, Georgia, United States
ACTIVE_NOT_RECRUITINGJohn Hopkins University
Columbia, Maryland, United States
TERMINATEDMichigan Medical
Ann Arbor, Michigan, United States
TERMINATEDResearch Institute of Michigan
Chesterfield, Michigan, United States
WITHDRAWN...and 103 more locations
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52.
Time frame: 52 weeks
Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)
Change in total Mayo score and 9-point modified Mayo score at week 52.
Time frame: 52 weeks
Subjects in corticosteroid-free remission at week 52 (Part 2)
Percentage of subjects in corticosteroid-free remission at week 52.
Time frame: 52 weeks
Subjects who maintain clinical remission at week 52 (Part 2)
Percentage of subjects who maintain clinical remission at week 52
Time frame: 52 weeks
Subjects in clinical remission per partial Mayo score at week E26 (Part 3)
The percentage of subjects in clinical remission per partial Mayo score at week E26.
Time frame: 26 weeks (extension)
Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)
The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26.
Time frame: 26 weeks (extension)
Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)
Change from baseline in Partial Mayo score at week E2, E12, and E26.
Time frame: 26 weeks (extension)