Brief Summary
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.
Brief Title
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Detailed Description
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ulcerative Colitis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
inclusion/
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
inclusion/
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
NCT02531126
Org Class
Industry
Org Full Name
Celgene
Org Study Id
RPC01-3102
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
Outcome Time Frame
From first dose to 90 days post last dose (Up to approximately 92 months)
Secondary Ids
Secondary Id
2015-001600-64
Secondary Id
U1111-1218-0284
Secondary Outcomes
Outcome Description
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).
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).
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Clinical Remission
Outcome Description
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.
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Clinical Response
Outcome Description
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)
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)
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Endoscopic Improvement
Outcome Description
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).
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).
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Corticosteroid-free Remission
Outcome Description
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.
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Histologic Remission
Outcome Description
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.)
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants With Mucosal Healing
Outcome Description
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.
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.
Outcome Time Frame
Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Outcome Measure
Change From Baseline in Complete Mayo Score
Outcome Description
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.
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.
Outcome Time Frame
Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Outcome Measure
Change From Baseline in Partial Mayo Score
Outcome Description
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.
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.
Outcome Time Frame
Baseline, week 46, 94, 142, 190, 238, 286, 334, 382
Outcome Measure
Change From Baseline in 9-Point Mayo Score
Outcome Description
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).
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).
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Remission
Outcome Description
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.
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Clinical Response
Outcome Description
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)
1 = Mild disease (erythema, decreased vascular pattern, does not include friability)
Outcome Time Frame
Week 46, 94, 142, 190, 238
Outcome Measure
Percentage of Participants Who Had Previously Received Anti-TNF Therapy With Endoscopic Improvement
See Also Links
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
Categories Mesh Debug
Digestive System --- COLITIS, ULCERATIVE
Digestive System --- COLITIS
Digestive System --- GASTROENTERITIS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- INFLAMMATORY BOWEL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
COLITIS, ULCERATIVE
COLITIS
GASTROENTERITIS
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES
INFLAMMATORY BOWEL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
OZANIMOD