The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
877
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Number of participants experiencing TEAEs, Serious TEAEs, TEAEs leading to discontinuation and TEAEs of special interest. TEAE is defined as any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity on or after the first dose date, and until 90 days following the last dose of treatment with the study drug.
Time frame: From first dose to 90 days post last dose (Up to approximately 92 months)
Percentage of Participants With Clinical Remission
Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Clinical Response
Clinical response is defined as reduction from baseline in the 9-point Mayo score of \>=2 points and reduction from baseline in the 9-point Mayo score \>=35%, and (reduction from baseline in the rectal bleeding subscore of \>=1 point or a rectal bleeding subscore of \<=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Endoscopic Improvement
Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1. = Mild disease (erythema, decreased vascular pattern, does not include friability) 2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3. = Severe disease (spontaneous bleeding, ulceration)
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Local Institution - 144
Tucson, Arizona, United States
Local Institution - 102
Anaheim, California, United States
Local Institution - 117
Mission Hills, California, United States
Local Institution - 112
Oak Lawn, Illinois, United States
Local Institution - 119
Baton Rouge, Louisiana, United States
Local Institution - 127
Jacksonville, North Carolina, United States
Local Institution - 290
Oklahoma City, Oklahoma, United States
Local Institution - 143
Portland, Oregon, United States
Local Institution - 179
Germantown, Tennessee, United States
Local Institution - 122
Dallas, Texas, United States
...and 31 more locations
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Corticosteroid-free Remission
Corticosteroid-free remission is defined as clinical remission while off corticosteroids for ≥12 weeks. Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Histologic Remission
Histologic remission is defined as Geboes index score \< 2.0. The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants With Mucosal Healing
Mucosal Healing is defined as Endoscopy subscore of ≤ 1 point (0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)) and a Geboes index score \< 2.0 (The Geboes score is a validated histological grading system for UC that ranges from 0=no disease activity to 5=high disease activity.)
Time frame: Week 46, 94, 142, 190, 238
Change From Baseline in Complete Mayo Score
The Complete Mayo Score is a composite of four assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) 4. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-12, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in Partial Mayo Score
The Partial Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Physician's Global Assessment (0 = Normal; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease). The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Change From Baseline in 9-Point Mayo Score
The 9-point Mayo Score is a composite of three assessments, each rated from 0 to 3: 1. Stool frequency: (0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal) 2. Rectal bleeding (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time; 3 = Blood alone passes) 3. Endoscopy (0 = Normal or inactive disease; 1 = Mild disease; 2 = Moderate disease; 3 = Severe disease) The total score range is from 0-9, with higher score indicating worse disease activity. Baseline is the last measurement collected on or prior to the date of first dose in the 3102 OLE study.
Time frame: Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission
Clinical Remission is defined as Rectal bleeding subscore=0; stool frequency subscore \<=1 (and a decrease of \>=1 point from the baseline stool frequency subscore); and endoscopy subscore \<=1. Rectal bleeding 0 = No blood seen Stool frequency 0 = Normal number of stools for this patient; 1 = 1 to 2 stools more than normal Endoscopy 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability).
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response
Clinical response is defined as reduction from baseline in the 9-point Mayo score of \>=2 points and reduction from baseline in the 9-point Mayo score \>=35%, and (reduction from baseline in the rectal bleeding subscore of \>=1 point or a rectal bleeding subscore of \<=1 point). 9 point Mayo score is defined as the sum of rectal bleeding subscore, stool frequency subscore, and the endoscopy subscore each ranging from (0=normal activity-3=worse activity) for a total score that ranges from 0 to 9 with higher score indicating worsening symptoms.
Time frame: Week 46, 94, 142, 190, 238
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement
Endoscopic Improvement is defined as endoscopy subscore of \<=1 point. 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, does not include friability)
Time frame: Week 46, 94, 142, 190, 238