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

• ClinicalTrials.gov Identifier: NCT02435992
• Recruitment Status: Recruiting
• First Posted: May 6, 2015
• Last Update Posted: October 22, 2019
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: April 24, 2015
• First Posted Date: May 6, 2015
• Last Update Posted Date: October 22, 2019
• Actual Study Start Date: June 17, 2015
• Estimated Primary Completion Date: June 29, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2015)

• Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 10 ]
  Induction Period
• Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 52 ]
  Maintenance Period

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02435992 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
• 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 3 separate cohorts (Cohort 1 and Cohort 2 for adults, Cohort 3 for adolescents). Patients from Cohort 1, 2, and 3 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1, 2, and 3 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ulcerative Colitis

Intervention

• Drug: RPC1063
• Drug: Placebo

Study Arms

• Experimental: RPC1063 (Ozanimod)
  1mg, daily oral administration during Induction and Maintenance periods.
  Intervention: Drug: RPC1063
• Placebo Comparator: Placebo
  Daily oral administration during Induction and Maintenance periods.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 1, 2015): 900
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 28, 2021
• Estimated Primary Completion Date: June 29, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged 18 to 75 years (at screening for Cohort 1 and 2)
• Male or female adolescent patients aged 12 to < 18 years (at screening) with a body weight greater than or equal to 45 kg
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Celgene True North Study True North Study; 1-844-266-9299; truenorth@quintiles.com

• Listed Location Countries: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Croatia, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Moldova, Republic of, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02435992
• Other Study ID Numbers: RPC01-3101
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Celgene
• Study Sponsor: Celgene
• Collaborators: Not Provided

Investigators

• Study Director: AnnKatrin Petersen, M.D., MSc.; Celgene

• PRS Account: Celgene
• Verification Date: October 2019