Trial Outcomes & Findings for Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease (NCT NCT02425111)
NCT ID: NCT02425111
Last Updated: 2018-09-14
Results Overview
Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Week 26
Results posted on
2018-09-14
Participant Flow
Participants took part in the study at 42 investigative sites in Belgium, Canada, Czech Republic, France, Hungary, Italy, Poland and the United States from 30 March 2015 to 21 February 2018.
Participants with a diagnosis of Crohn's Disease were enrolled and received vedolizumab.
Participant milestones
| Measure |
Vedolizumab 300 mg
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Treatment Period
STARTED
|
101
|
|
Part A: Treatment Period
COMPLETED
|
78
|
|
Part A: Treatment Period
NOT COMPLETED
|
23
|
|
Part B: Treatment Extension Period
STARTED
|
56
|
|
Part B: Treatment Extension Period
COMPLETED
|
46
|
|
Part B: Treatment Extension Period
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Vedolizumab 300 mg
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Treatment Period
Pretreatment Event/Adverse Event
|
2
|
|
Part A: Treatment Period
Lack of Efficacy
|
15
|
|
Part A: Treatment Period
Voluntary Withdrawal
|
4
|
|
Part A: Treatment Period
Lost to Follow-up
|
2
|
|
Part B: Treatment Extension Period
Pretreatment Event/Adverse Event(s)
|
3
|
|
Part B: Treatment Extension Period
Lack of Efficacy
|
7
|
Baseline Characteristics
FAS included all enrolled participants who received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 14.00 • n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
32 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
Not Collected
|
68 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Race/Ethnicity, Customized
White
|
98 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Belgium
|
8 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Canada
|
14 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Czech Republic
|
14 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Hungary
|
14 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Italy
|
9 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
Poland
|
7 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Height
|
172.5 cm
STANDARD_DEVIATION 9.81 • n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Weight
|
73.94 kg
STANDARD_DEVIATION 18.795 • n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Body Mass Index (BMI)
|
24.71 kg/m^2
STANDARD_DEVIATION 5.365 • n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Smoking Classification
Participant has never smoked
|
46 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Smoking Classification
Participant is a current smoker
|
33 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Smoking Classification
Participant is an ex-smoker
|
22 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Female Reproductive Status
Postmenopausal
|
6 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Female Reproductive Status
Surgically Sterile
|
9 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Female Reproductive Status
Female of Childbearing Potential
|
34 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Female Reproductive Status
N/A (Participant is a Male)
|
52 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
|
Number of Participants with Endoscopic Remission
|
3 Participants
n=5 Participants • FAS included all enrolled participants who received at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: Week 26Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Endoscopic Remission at Week 26
|
11.9 percentage of participants
Interval 6.3 to 19.8
|
SECONDARY outcome
Timeframe: Week 26Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Complete mucosal healing is defined as absence of ulceration.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Complete Mucosal Healing at Week 26
|
14.9 percentage of participants
Interval 8.6 to 23.3
|
SECONDARY outcome
Timeframe: Week 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.
Complete mucosal healing is defined as absence of ulceration.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants Achieving Complete Mucosal Healing at Week 52
|
17.9 percentage of participants
Interval 8.9 to 30.4
|
SECONDARY outcome
Timeframe: Week 14Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Endoscopic Remission at Week 14
|
16.8 percentage of participants
Interval 10.1 to 25.6
|
SECONDARY outcome
Timeframe: Week 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants Achieving Endoscopic Remission at Week 52
|
16.1 percentage of participants
Interval 7.6 to 28.3
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants With Endoscopic Response at Week 14
|
33.7 percentage of participants
Interval 24.6 to 43.8
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants With Endoscopic Response at Week 26
|
24.8 percentage of participants
Interval 16.7 to 34.3
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.
Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants With Endoscopic Response at Week 52
|
51.8 percentage of participants
Interval 38.0 to 65.3
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical response is defined as Crohn's Disease Activity Index (CDAI) decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Clinical Response at Week 10
|
54.5 percentage of participants
Interval 44.2 to 64.4
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Clinical Response at Week 26
|
60.4 percentage of participants
Interval 50.2 to 70.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants Achieving Clinical Response at Week 52
|
58.9 percentage of participants
Interval 45.0 to 71.9
|
SECONDARY outcome
Timeframe: Week 10Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Clinical Remission at Week 10
|
35.6 percentage of participants
Interval 26.4 to 45.8
|
SECONDARY outcome
Timeframe: Week 26Population: FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=101 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part A: Percentage of Participants Achieving Clinical Remission at Week 26
|
41.6 percentage of participants
Interval 31.9 to 51.8
|
SECONDARY outcome
Timeframe: Week 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.
Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants Achieving Clinical Remission at Week 52
|
50.0 percentage of participants
Interval 36.3 to 63.7
|
SECONDARY outcome
Timeframe: Weeks 26 and 52Population: FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug. Participants with missing durable clinical remission status are considered as No durable clinical remission.
Durable clinical remission is defined as clinical remission at both Week 26 and Week 52. Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The percentage of participants assessed at Week 52 who had clinical remission at Week 26 of Part A and also had clinical remission at Week 52 is reported.
Outcome measures
| Measure |
Vedolizumab 300 mg
n=56 Participants
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|
|
Part B: Percentage of Participants With Durable Clinical Remission
|
37.5 percentage of participants
Interval 24.9 to 51.5
|
Adverse Events
Vedolizumab 300 mg Part A
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Vedolizumab 300 mg Part B
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vedolizumab 300 mg Part A
n=101 participants at risk
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22.
|
Vedolizumab 300 mg Part B
n=56 participants at risk
Following Part A, Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
5.9%
6/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Gastrointestinal disorders
Anal fistula
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
General disorders
Asthenia
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Abdominal abscess
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Gastroenteritis
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Osteomyelitis
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Vascular disorders
Aortic aneurysm
|
0.99%
1/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Infected bite
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
1.8%
1/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
Other adverse events
| Measure |
Vedolizumab 300 mg Part A
n=101 participants at risk
Part A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22.
|
Vedolizumab 300 mg Part B
n=56 participants at risk
Following Part A, Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
11.9%
12/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
8.9%
5/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
6/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
5.4%
3/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
5/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
5.4%
3/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Nervous system disorders
Headache
|
5.0%
5/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/101 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
0.00%
0/56 • First dose of study drug and up to the last dose or early termination plus 18-week follow-up if applicable (Up to 44 Weeks for Part A Treatment and Up to 70 Weeks for Part B Extension)
At each visit adverse events (AEs) and abnormal laboratory findings reported by participant or observed by the investigator were recorded, irrespective of relation to study treatment. Due to the design of the study, the most common (≥ 5%) non-serious AEs were determined separately for each period of the study, Part A and Part B. A result of 0 in a column means that the event did not meet the ≥ 5% threshold for that study period but did meet the threshold for the other study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER