Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Phase 3

Completed

Brief Summary: The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Detailed Description: The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Recruitment & Eligibility

Inclusion Criteria

Aged 18 to 75 years (at screening for Cohort 1 and 2)
UC confirmed on endoscopy
Moderately to severely active UC (May score 6-12)
Currently receiving treatment with aminosalisylate, prednisone, or budesonide
Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria

Have severe extensive colitis as evidence by:
Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
History of uveitis or unknown macular edema
Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Arm && Interventions

Group	Intervention	Description
RPC1063 (Ozanimod)	RPC1063	1mg, daily oral administration during Induction and Maintenance periods.
Placebo	Placebo	Daily oral administration during Induction and Maintenance periods.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in Clinical Remission at 10 Weeks	At 10 Weeks	Percentage of participants that are in Clinical remission at 10 weeks
Percentage of Participants in Clinical Remission at 52 Weeks	At 52 Weeks	Percentage of participants that are in Clinical remission at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Endoscopic Improvement at 10 Weeks	At 10 Weeks	Percentage of participants with endoscopic improvement at 10 weeks
Percentage of Participants With Endoscopic Improvement at 52 Weeks	At 52 Weeks	Percentage of participants with endoscopic improvement at 52 weeks
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10	At 52 Weeks	Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Percentage of Participants With Clinical Response at 10 Weeks	At 10 Weeks	Percentage of participants that are in Clinical response at 10 weeks
Percentage of Participants With Mucosal Healing at 10 Weeks	At 10 Weeks	Percentage of participants with mucosal healing at 10 weeks
Percentage of Participants in Clinical Response at 52 Weeks	At 52 Weeks	Percentage of participants that are in Clinical response at 52 weeks
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks	At 52 Weeks	Percentage of participants with corticosteroid free remission at 52 weeks
Percentage of Participants With Mucosal Healing at 52 Weeks	At 52 Weeks	Percentage of participants with Mucosal Healing at 52 weeks
Percentage of Participants With Durable Clinical Remission at 52 Weeks	At 52 Weeks	Percentage of participants with durable clinical remission at 52 weeks

Locations (371): Arizona Digestive Health
🇺🇸
Sun City, Arizona, United States
Adobe Clinical Research LLC
🇺🇸
Tucson, Arizona, United States
Arkansas Gastroenterology, P.A.
🇺🇸
North Little Rock, Arkansas, United States
Anaheim Clinical Trials
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Anaheim, California, United States
Aurora Care Clinic
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Costa Mesa, California, United States
Valley View Internal Medicine
🇺🇸
Garden Grove, California, United States
Davita Clinical Trials, LLC
🇺🇸
Huntington Beach, California, United States
University of California San Diego Medical Center
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La Jolla, California, United States
OM Research
🇺🇸
Lancaster, California, United States
University of Southern California - Keck School of Medicine
🇺🇸
Los Angeles, California, United States
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Arizona Digestive Health
🇺🇸Sun City, Arizona, United States