The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Specified dose on specified days
Proportion of participants who achieve clinical remission
Time frame: At Week 52
Proportion of participants who achieve clinical remission
Time frame: At Week 10
Proportion of participants who achieve clinical response
Time frame: At Week 52
Proportion of participants who achieve clinical response
Time frame: At Week 10
Proportion of participants who achieve symptomatic remission
Time frame: At Week 10 and Week 52
Time to achievement of symptomatic remission
Time frame: Up to 6 years
Proportion of participants who achieve endoscopic improvement
Time frame: At Week 10 and Week 52
Proportion of participants who achieve corticosteroid free remission
Time frame: At Week 52
Incidence of Adverse Events (AEs)
Time frame: Up to 6 years
Incidence of Serious Adverse Events
Time frame: Up to 6 years
Incidence of AEs leading to discontinuation from treatment
Time frame: Up to 6 years
Incidence of AEs of special interest (AESIs)
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CONTACT
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Local Institution - 0041
Phoenix, Arizona, United States
WITHDRAWNUniversity of Arizona
Tucson, Arizona, United States
WITHDRAWNLocal Institution - 0052
Garden Grove, California, United States
COMPLETEDLoma Linda University Health System
Loma Linda, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGLucile Packard Children's Hospital
Palo Alto, California, United States
NOT_YET_RECRUITINGLocal Institution - 0096
Sacramento, California, United States
NOT_YET_RECRUITINGLocal Institution - 0007
Hartford, Connecticut, United States
COMPLETEDLocal Institution - 0064
Washington D.C., District of Columbia, United States
COMPLETEDLocal Institution - 0075
Orlando, Florida, United States
COMPLETED...and 79 more locations
Time frame: Up to 6 years
Steady state systemic exposure of ozanimod and CC112273
Time frame: At Week 18 and throughout the study, up to 70 weeks
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Time frame: Up to 6 years
Percent change from baseline in ALC
Time frame: Up to 6 years