A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
- Registration Number
- NCT03464097
- Lead Sponsor
- Celgene
- Brief Summary
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 550
- Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study
- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ozanimod Ozanimod - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed Week 52 The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores Week 52 The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed Week 52 The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52 Week 52 Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1 Week 52 Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1 Week 52 The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases Week 52 The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores Week 52 CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52 Week 52 Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52 Week 52 CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases Week 52 CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1 Week 52 CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52 Week 52 The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD Week 52 CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52 Week 52 CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.
Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1 Week 52 The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Percentage of Participants With Average Daily Abdominal Pain Score ≤ 1 Point and Average Daily Stool Frequency Score ≤3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and SES-CD Decrease From Baseline ≥ 50% at Week 52 Week 52 Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Trial Locations
- Locations (762)
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Local Institution - 202
🇺🇸Scottsdale, Arizona, United States
Local Institution - 026
🇺🇸North Little Rock, Arkansas, United States
Local Institution - 284
🇺🇸Camarillo, California, United States
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Local Institution - 039
🇺🇸Garden Grove, California, United States
Ucsd Medical Center
🇺🇸La Jolla, California, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Local Institution - 010
🇺🇸Lancaster, California, United States
Local Institution - 061
🇺🇸Los Angeles, California, United States
Scroll for more (752 remaining)Holland Center for Family Health🇺🇸Peoria, Arizona, United States