Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Brief Title
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ulcerative Colitis
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT02435992
Org Class
Industry
Org Full Name
Celgene
Org Study Id
RPC01-3101
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Percentage of participants that are in Clinical remission at 10 weeks
Outcome Measure
Percentage of Participants in Clinical Remission at 10 Weeks
Outcome Time Frame
At 10 Weeks
Outcome Description
Percentage of participants that are in Clinical remission at 52 weeks
Outcome Measure
Percentage of Participants in Clinical Remission at 52 Weeks
Outcome Time Frame
At 52 Weeks
Secondary Outcomes
Outcome Description
Percentage of participants that are in Clinical response at 10 weeks
Outcome Time Frame
At 10 Weeks
Outcome Measure
Percentage of Participants With Clinical Response at 10 Weeks
Outcome Description
Percentage of participants with endoscopic improvement at 10 weeks
Outcome Time Frame
At 10 Weeks
Outcome Measure
Percentage of Participants With Endoscopic Improvement at 10 Weeks
Outcome Description
Percentage of participants with mucosal healing at 10 weeks
Outcome Time Frame
At 10 Weeks
Outcome Measure
Percentage of Participants With Mucosal Healing at 10 Weeks
Outcome Description
Percentage of participants that are in Clinical response at 52 weeks
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants in Clinical Response at 52 Weeks
Outcome Description
Percentage of participants with endoscopic improvement at 52 weeks
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants With Endoscopic Improvement at 52 Weeks
Outcome Description
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
Outcome Description
Percentage of participants with corticosteroid free remission at 52 weeks
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Outcome Description
Percentage of participants with Mucosal Healing at 52 weeks
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants With Mucosal Healing at 52 Weeks
Outcome Description
Percentage of participants with durable clinical remission at 52 weeks
Outcome Time Frame
At 52 Weeks
Outcome Measure
Percentage of Participants With Durable Clinical Remission at 52 Weeks
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Thomas Ullman
Investigator Email
tullman@montefiore.org
Investigator Phone
347-671-8211