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Clinical Trial Results:
Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects with Moderate or Severe Crohn's Disease

Summary
EudraCT number	2019-001199-12
Trial protocol	Outside EU/EEA
Global end of trial date	21 May 2019

Results information
Results version number	v1(current)
This version publication date	18 Dec 2019
First version publication date	18 Dec 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

MLN0002/CCT-001

ISRCTN number

US NCT number

NCT02038920

WHO universal trial number (UTN)

U1111-1150-2688

Other trial identifiers

Japan Ministry of Health, Labour and Welfare: JapicCTI-142402

Sponsor organisation name

Takeda

Sponsor organisation address

Takeda Pharmaceutical Company Limited, 1-1, Doshomachi 4-chome, Chuo-ku, Osaka-shi, Osaka, Japan,

Public contact

Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com

Scientific contact

Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

21 May 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 May 2019

Was the trial ended prematurely?

Main objective of the trial

This study is a phase 3, multicenter, randomised, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Protection of trial subjects

All study participants were required to read and sign an Informed Consent Form.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Jan 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 157

Worldwide total number of subjects

157

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

149

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants took part in the study at 77 investigative sites in Japan from 28 Jan 2014 to 21 May 2019.

Screening details

Participants with moderate to severe Crohn’s disease were enrolled. 157 participants enrolled in induction phase, 41 participants entered maintenance phase and 134 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and 154 through study with maximum of 94 weeks of treatment.

Period 1 title

Induction Phase (Week 0 to 14)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst

Are arms mutually exclusive

Yes

Induction Phase: Vedolizumab, 300 mg

Arm description

Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.

Arm type

Experimental

Investigational medicinal product name

Vedolizumab

Investigational medicinal product code

Other name

MLN0002

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Vedolizumab IV injection

Induction Phase: Placebo

Arm description

Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.

Arm type

Placebo

Investigational medicinal product name

Vedolizumab placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Vedolizumab placebo-matching IV infusion

Number of subjects in period 1	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo
Started	79	78
Completed	73	66
Not completed	6	12
Pretreatment Event/Adverse Event	3	11
Voluntary Withdrawal	2	-
Lack of efficacy	1	1

Period 2 title

Maintenance Phase (Week 14 to 60)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst

Are arms mutually exclusive

Yes

Maintenance Phase: Vedolizumab 300 mg

Arm description

Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.

Arm type

Experimental

Investigational medicinal product name

Vedolizumab

Investigational medicinal product code

Other name

MLN0002

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

Vedolizumab IV injection

Maintenance Phase: Placebo

Arm description

Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.

Arm type

Placebo

Investigational medicinal product name

Vedolizumab placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Vedolizumab placebo-matching IV infusion

Maintenance Phase: Placebo Continuation

Arm description

Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.

Arm type

Placebo

Investigational medicinal product name

Vedolizumab placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Vedolizumab placebo-matching IV infusion

Number of subjects in period 2 ^[1]	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation
Started	12	12	17
Completed	7	4	5
Not completed	5	8	12
Pretreatment Event/Adverse Event	2	4	2
Lost to follow-up	1	-	-
Lack of efficacy	2	4	10

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Not all participants from the Induction Phase entered the Maintenance Phase.

Baseline characteristics

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Reporting group title

Induction Phase: Vedolizumab, 300 mg

Reporting group description

Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.

Reporting group title

Induction Phase: Placebo

Reporting group description

Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.

Reporting group values	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo	Total
Number of subjects	79	78
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	33.9 ± 12.25	32.6 ± 10.93	-
Sex: Female, Male
Units: Subjects
Female	28	26	54
Male	51	52	103
Disease Localization
Units: Subjects
Small Intestine Type	13	9	22
Large Intestine Type	11	19	30
Small/large Intestine Type	55	50	105
Smoking Classification
Units: Subjects
Never Smoked	46	42	88
Current Smoker	13	11	24
Ex-smoker	20	25	45
Extraintestinal Manifestations (Based on CDAI subscore)
CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Units: Subjects
Had No Extraintestinal Manifestations	24	22	46
Had Extraintestinal Manifestations	55	56	111
Extraintestinal Manifestations (Based on Case Report Form)
Units: Subjects
Had No Extraintestinal Manifestations	42	52	94
Had Extraintestinal Manifestations	37	26	63
History of Prior Surgery for Crohn's Disease (CD)
Units: Subjects
Had No Surgical History	55	48	103
Had Surgical History	24	30	54
Current Medical Condition Related to Fistula
Units: Subjects
Had No Current Medical Condition	72	66	138
Had Current Medical Condition	7	12	19
Region of Enrollment
Units: Subjects
Japan	79	78	157
Height
Units: cm
arithmetic mean (standard deviation)	166.3 ± 8.73	166.4 ± 7.97	-
Weight
Units: kg
arithmetic mean (standard deviation)	58.53 ± 14.095	55.03 ± 8.928	-
Body Mass Index (BMI)
Body Mass Index = weight(kg)/[height(m)^2]
Units: kg/m^2
arithmetic mean (standard deviation)	21.15 ± 4.942	19.81 ± 2.567	-
Duration of Crohn's Disease
Duration between the first diagnosis of Crohn's disease and the start of the study was reported.
Units: years
median (full range (min-max))	7.20 (0.3 to 27.8)	8.35 (0.3 to 32.0)	-
C-Reactive Protein (CRP)
Units: mg/dL
arithmetic mean (standard deviation)	2.234 ± 2.1763	2.848 ± 3.2303	-
CDAI Score at Week 0
CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600 , where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Units: score on a scale
arithmetic mean (standard deviation)	303.9 ± 63.19	295.0 ± 64.81	-

End points

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Reporting group title

Induction Phase: Vedolizumab, 300 mg

Reporting group description

Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.

Reporting group title

Induction Phase: Placebo

Reporting group description

Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.

Reporting group title

Maintenance Phase: Vedolizumab 300 mg

Reporting group description

Reporting group title

Maintenance Phase: Placebo

Reporting group description

Reporting group title

Maintenance Phase: Placebo Continuation

Reporting group description

Subject analysis set title

Open-Label: Vedolizumab 300 mg

Subject analysis set type

Safety analysis

Subject analysis set description

Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.

Primary: Induction phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

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End point title

Induction phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

End point description

A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease. Full analysis set (FAS) in the induction phase included participants who were randomised and received at least one dose of the study drug in induction phase.

End point type

Primary

End point timeframe

Week 10

End point values	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo
Number of subjects analysed	79	78
Units: percentage of participants
number (confidence interval 95%)	26.6 (17.268 to 37.720)	16.7 (9.184 to 26.813)

Statistical Analysis 1

Statistical analysis description

MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.

Comparison groups

Induction Phase: Vedolizumab, 300 mg v Induction Phase: Placebo

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1448

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.816

upper limit

3.958

Primary: Maintenance Phase: Percentage of Participants with Clinical Remission

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End point title

Maintenance Phase: Percentage of Participants with Clinical Remission

End point description

Clinical remission is defined as the CDAI score ≤150. CDAI is 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. FAS in the maintenance phase included participants who were randomised and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

End point type

Primary

End point timeframe

Week 60

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: percentage of participants
number (confidence interval 95%)	41.7 (15.165 to 72.333)	16.7 (2.086 to 48.414)

Statistical Analysis 1

Statistical analysis description

MLN0002 group/placebo group

Comparison groups

Maintenance Phase: Vedolizumab 300 mg v Maintenance Phase: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1779

Method

Pearson's Chi-square Test

Parameter type

Odds ratio (OR)

Point estimate

3.57

Confidence interval

level

95%

sides

2-sided

lower limit

0.532

upper limit

23.953

Primary: Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)

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End point title

Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) ^[1]

End point description

An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

End point type

Primary

End point timeframe

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses are reported for this end point.

End point values	Induction Phase: Vedolizumab, 300 mg	Maintenance Phase: Vedolizumab 300 mg	Induction Phase: Placebo	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	79	12	78	12	17	134
Units: participants	49	9	42	10	12	130

No statistical analyses for this end point

Primary: Number of Participants with TEAE Related to Body Weight (Weight Decreased)

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End point title

Number of Participants with TEAE Related to Body Weight (Weight Decreased) ^[2]

End point description

Reported events on this outcome measure were “Weight Decreased”. Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

End point type

Primary

End point timeframe

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses are reported for this end point.

End point values	Induction Phase: Vedolizumab, 300 mg	Maintenance Phase: Vedolizumab 300 mg	Induction Phase: Placebo	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	79	12	78	12	17	134
Units: participants	0	0	0	0	0	2

No statistical analyses for this end point

Primary: Number of Participants with TEAE Related to Vital Signs

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End point title

Number of Participants with TEAE Related to Vital Signs ^[3]

End point description

Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were “Pyrexia”, “Body temperature increased”, “Hypertension”, and “Orthostatic hypotension”. Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

End point type

Primary

End point timeframe

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses are reported for this end point.

End point values	Induction Phase: Vedolizumab, 300 mg	Maintenance Phase: Vedolizumab 300 mg	Induction Phase: Placebo	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	79	12	78	12	17	134
Units: participants
Pyrexia	3	0	1	1	1	19
Body Temperature Increased	1	0	0	0	0	0
Hypertension	0	1	0	0	0	1
Orthostatic Hypotension	0	0	0	0	0	1

No statistical analyses for this end point

Primary: Number of Participants with TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]

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End point title

Number of Participants with TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] ^[4]

End point description

Reported events on this outcome measure were “Bundle Branch Block Right”. Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

End point type

Primary

End point timeframe

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses are reported for this end point.

End point values	Induction Phase: Vedolizumab, 300 mg	Maintenance Phase: Vedolizumab 300 mg	Induction Phase: Placebo	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	79	12	78	12	17	134
Units: participants	0	0	0	0	0	1

No statistical analyses for this end point

Primary: Number of Participants with Markedly Abnormal Values of Laboratory Parameters Values

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End point title

Number of Participants with Markedly Abnormal Values of Laboratory Parameters Values ^[5]

End point description

The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal. Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

End point type

Primary

End point timeframe

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses are reported for this end point.

End point values	Induction Phase: Vedolizumab, 300 mg	Maintenance Phase: Vedolizumab 300 mg	Induction Phase: Placebo	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	79	11	78	12	17	134
Units: participants
Hemoglobin (g/dL) <=7	0	0	1	0	0	4
Lymphocytes (/uL) <500	7	1	6	2	1	18
WBC (/uL) <2000	0	0	0	0	0	1
Platelets (10^4/uL) <7.5	0	0	0	0	0	1
Neutrophils (/uL) <1000	0	0	0	0	0	1
ALT (GPT) (U/L) >3.0 x ULN	1	0	1	0	0	1
AST (GOT) (U/L) >3.0 x ULN	1	0	0	0	0	1
Total Bilirubin (mg/dL) >2.0 x ULN	0	0	0	0	0	4
Amylase (U/L) >2.0 x ULN	1	0	0	0	0	8

No statistical analyses for this end point

Secondary: Induction phase: Percentage of Participants with Clinical Remission

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End point title

Induction phase: Percentage of Participants with Clinical Remission

End point description

Clinical remission is defined as the CDAI score ≤150. CDAI is 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. FAS in the induction phase included participants who were randomised and received at least one dose of the study drug in induction phase.

End point type

Secondary

End point timeframe

Week 10

End point values	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo
Number of subjects analysed	79	78
Units: percentage of participants
number (confidence interval 95%)	17.7 (10.041 to 27.942)	10.3 (4.533 to 19.213)

Statistical Analysis 1

Statistical analysis description

MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.

Comparison groups

Induction Phase: Vedolizumab, 300 mg v Induction Phase: Placebo

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1963

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

1.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

4.673

Secondary: Induction phase: Change from Baseline in C-reactive Protein (CRP) Values

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End point title

Induction phase: Change from Baseline in C-reactive Protein (CRP) Values

End point description

Participants from 'FAS in the induction phase' with CRP value exceeding 0.30 mg/dL at Baseline were analysed at given time point. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Baseline to Week 10

End point values	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo
Number of subjects analysed	79	78
Units: mg/dL
arithmetic mean (standard deviation)
Change from Baseline at Week 2 (n=64, 70)	0.022 ± 2.1421	-0.125 ± 2.8417
Change from Baseline at Week 6 (n=61, 65)	-0.089 ± 2.0266	0.130 ± 2.1674
Change from Baseline at Week 10 (n=60, 59)	-0.164 ± 2.2729	0.077 ± 2.8690

No statistical analyses for this end point

Secondary: Maintenance Phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

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End point title

Maintenance Phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

End point description

A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease. FAS in the maintenance phase included participants who were randomised and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

End point type

Secondary

End point timeframe

Week 60

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: percentage of participants
number (confidence interval 95%)	58.3 (27.667 to 84.835)	8.3 (0.211 to 38.480)

Statistical Analysis 1

Comparison groups

Maintenance Phase: Vedolizumab 300 mg v Maintenance Phase: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0094

Method

Pearson's Chi-square Test

Parameter type

Odds ratio (OR)

Point estimate

15.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.473

upper limit

160.972

Secondary: Maintenance Phase: Percentage of Participants with Durable Clinical Remission

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End point title

Maintenance Phase: Percentage of Participants with Durable Clinical Remission

End point description

Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease. FAS in the maintenance phase included participants who were randomised and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

End point type

Secondary

End point timeframe

From Week 14 and Week 60

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: percentage of participants
number (confidence interval 95%)	33.3 (9.925 to 65.112)	25.0 (5.486 to 57.186)

Statistical Analysis 1

Statistical analysis description

MLN0002 group/placebo group

Comparison groups

Maintenance Phase: Vedolizumab 300 mg v Maintenance Phase: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6534

Method

Pearson's Chi-square Test

Parameter type

Odds ratio (OR)

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.254

upper limit

8.844

Secondary: Maintenance Phase: Percentage of Participants with Corticosteroid-free Clinical Remission

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End point title

Maintenance Phase: Percentage of Participants with Corticosteroid-free Clinical Remission

End point description

Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease. Participants from FAS in maintenance phase included participants who were randomised and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analsed at the given timepoint.

End point type

Secondary

End point timeframe

Week 60

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	5	3
Units: percentage of participants
number (confidence interval 95%)	40.0 (5.274 to 85.337)	0.0 (0.000 to 70.760)

Statistical Analysis 1

Comparison groups

Maintenance Phase: Vedolizumab 300 mg v Maintenance Phase: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2059

Method

Pearson's Chi-square Test

Confidence interval

Secondary: Serum Vedolizumab Concentration in Induction Phase

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End point title

Serum Vedolizumab Concentration in Induction Phase ^[6]

End point description

Participants from 'FAS in Induction Phase', who were randomised and received at least one dose of the study drug in the induction phase and for whom samples were available for pharmacokinetic (PK) analysis. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Weeks 2, 6, 10 and 14

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all participants from the Baseline Period are applicable for this endpoint.

End point values	Induction Phase: Vedolizumab, 300 mg
Number of subjects analysed	79
Units: ug/mL
arithmetic mean (standard deviation)
Week 2 (n=57)	28.23 ± 11.018
Week 6 (n=50)	21.01 ± 14.076
Week 10 (n=60)	22.31 ± 14.049
Week 14 (n=17)	12.24 ± 10.350

No statistical analyses for this end point

Secondary: Serum Vedolizumab Concentration in Maintenance Phase

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End point title

Serum Vedolizumab Concentration in Maintenance Phase

End point description

Participants from 'FAS in Maintenance Phase', who were randomised and received at least one dose of the study drug in the maintenance phase and for whom samples were available for PK analysis. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Weeks 2, 6, 10, 14, 22, 30 and 60

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: ug/mL
arithmetic mean (standard deviation)
Week 2 (n=10, 9)	29.32 ± 13.880	30.54 ± 9.7495
Week 6 (n=10, 9)	25.19 ± 17.054	24.90 ± 14.490
Week 10 (n=11, 9)	26.24 ± 15.464	26.60 ± 15.642
Week 14 (n=10, 7)	11.20 ± 8.5793	13.72 ± 13.072
Week 22 (n=9, 7)	9.102 ± 6.1809	1.502 ± 2.8285
Week 30 (n=8, 4)	9.013 ± 6.8774	0.000 ± 0.0000
Week 60 (n=6, 3)	13.68 ± 4.2659	0.000 ± 0.0000

No statistical analyses for this end point

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Induction Phase

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End point title

Number of Participants with Anti-vedolizumab Antibodies (AVA) in Induction Phase ^[7]

End point description

Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analysed in this outcome measure. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all participants from the Baseline Period are applicable for this endpoint.

End point values	Induction Phase: Vedolizumab, 300 mg
Number of subjects analysed	79
Units: participants
Week 0 (n=63)	1
Week 10 (n=63)	1
16 Weeks After Last Administration (n=4)	0

No statistical analyses for this end point

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

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End point title

Number of Participants with Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

End point description

Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analysed in this outcome measure. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: participants
Week 0 (n=11, 9)	0	0
Week 10 (n=11, 9)	0	0
Week 30 (n=10, 9)	0	2
Week 60 (n=9, 4)	0	1
16 Weeks After Last Administration (n=1, 1)	0	0

No statistical analyses for this end point

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

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End point title

Number of Participants with Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

End point description

Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analysed in this outcome measure. Number analysed is the number of participants with evaluable data at the given time-point.

End point type

Secondary

End point timeframe

Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

End point values	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	134
Units: participants
Week 0 (n=57)	2
Week 10 (n=108)	2
Week 30 (n=94)	2
Week 62 (n=66)	0
Week 94 (n=49)	0
16 Weeks After Last Administration (n=98)	2

No statistical analyses for this end point

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase

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End point title

Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase ^[8]

End point description

End point type

Secondary

End point timeframe

Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all participants from the Baseline Period are applicable for this endpoint.

End point values	Induction Phase: Vedolizumab, 300 mg
Number of subjects analysed	79
Units: participants
Week 0 (n=63)	0
Week 10 (n=63)	1
16 Weeks After Last Administration (n=4)	0

No statistical analyses for this end point

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

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End point title

Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

End point description

End point type

Secondary

End point timeframe

Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

End point values	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo
Number of subjects analysed	12	12
Units: participants
Week 0 (n=11, 9)	0	0
Week 10 (n=11, 9)	0	0
Week 30 (n=10, 9)	0	2
Week 60 (n=9, 4)	0	1
16 Weeks After Last Administration (n=1, 1)	0	0

No statistical analyses for this end point

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

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End point title

Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

End point description

End point type

Secondary

End point timeframe

Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

End point values	Open-Label: Vedolizumab 300 mg
Number of subjects analysed	134
Units: participants
Week 0 (n=57)	2
Week 10 (n=108)	2
Week 30 (n=94)	1
Week 62 (n=66)	0
Week 94 (n=49)	0
16 Weeks After Last Administration (n=98)	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Adverse event reporting additional description

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Induction Phase: Vedolizumab, 300 mg

Reporting group description

Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.

Reporting group title

Induction Phase: Placebo

Reporting group description

Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.

Reporting group title

Maintenance Phase: Vedolizumab 300 mg

Reporting group description

Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.

Reporting group title

Maintenance Phase: Placebo

Reporting group description

Reporting group title

Maintenance Phase: Placebo Continuation

Reporting group description

Reporting group title

Open-Label: Vedolizumab 300 mg

Reporting group description

Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.

Serious adverse events	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Total subjects affected by serious adverse events
subjects affected / exposed	8 / 79 (10.13%)	10 / 78 (12.82%)	2 / 12 (16.67%)	4 / 12 (33.33%)	2 / 17 (11.76%)	70 / 134 (52.24%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Intestinal anastomosis complication
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post lumbar puncture syndrome
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyslalia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intracranial hypotension
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Inflammation
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactoid reaction
subjects affected / exposed	0 / 79 (0.00%)	1 / 78 (1.28%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Crohn's disease
subjects affected / exposed	2 / 79 (2.53%)	10 / 78 (12.82%)	1 / 12 (8.33%)	2 / 12 (16.67%)	1 / 17 (5.88%)	35 / 134 (26.12%)
occurrences causally related to treatment / all	0 / 2	3 / 10	0 / 1	0 / 2	0 / 1	3 / 39
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 79 (0.00%)	1 / 78 (1.28%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	2 / 134 (1.49%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	4 / 134 (2.99%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	3 / 134 (2.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal stenosis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	3 / 134 (2.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileal stenosis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestinal stenosis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic function abnormal
subjects affected / exposed	0 / 79 (0.00%)	1 / 78 (1.28%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleurisy
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Erythema nodosum
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Ureterolithiasis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	4 / 134 (2.99%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	2 / 134 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	2 / 134 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mesenteric abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mycotic endophthalmitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periumbilical abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 79 (1.27%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	1 / 134 (0.75%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Induction Phase: Vedolizumab, 300 mg	Induction Phase: Placebo	Maintenance Phase: Vedolizumab 300 mg	Maintenance Phase: Placebo	Maintenance Phase: Placebo Continuation	Open-Label: Vedolizumab 300 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 79 (21.52%)	19 / 78 (24.36%)	9 / 12 (75.00%)	7 / 12 (58.33%)	12 / 17 (70.59%)	113 / 134 (84.33%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Skin papilloma
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 17 (5.88%)	19 / 134 (14.18%)
occurrences all number	0	0	0	1	1	30
Chest pain
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Swelling
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Immune system disorders
Allergy to metals
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Seasonal allergy
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	1	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	9 / 134 (6.72%)
occurrences all number	0	0	0	0	0	13
Investigations
Blood urine present
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Glucose urine present
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Injury, poisoning and procedural complications
Bone contusion
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Heat illness
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	1 / 79 (1.27%)	4 / 78 (5.13%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	9 / 134 (6.72%)
occurrences all number	1	4	0	0	0	9
Hypoaesthesia
subjects affected / exposed	4 / 79 (5.06%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	4	0	0	0	0	0
Cervicobrachial syndrome
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Anaemia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	13 / 134 (9.70%)
occurrences all number	0	0	0	0	0	16
Gastrointestinal disorders
Crohn's disease
subjects affected / exposed	0 / 79 (0.00%)	5 / 78 (6.41%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 17 (11.76%)	27 / 134 (20.15%)
occurrences all number	0	5	0	0	2	28
Diarrhoea
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	1	1	0
Abdominal pain
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Abdominal pain upper
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	9 / 134 (6.72%)
occurrences all number	0	0	0	1	0	10
Constipation
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	0	1	0	0
Dental caries
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	15 / 134 (11.19%)
occurrences all number	0	0	0	0	2	17
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Nausea
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	11 / 134 (8.21%)
occurrences all number	0	0	1	0	0	11
Stomatitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	0	2	0	0
Hepatobiliary disorders
Hepatic function abnormal
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	10 / 134 (7.46%)
occurrences all number	0	0	0	0	0	11
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	0	1	0	0
Dermatitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Dry skin
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Eczema
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	0	1	0	0
Ingrowing nail
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Pruritus
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	8 / 134 (5.97%)
occurrences all number	0	0	0	0	0	9
Infections and infestations
Nasopharyngitis
subjects affected / exposed	11 / 79 (13.92%)	11 / 78 (14.10%)	4 / 12 (33.33%)	4 / 12 (33.33%)	4 / 17 (23.53%)	55 / 134 (41.04%)
occurrences all number	12	13	6	6	6	90
Enteritis infectious
subjects affected / exposed	4 / 79 (5.06%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	4	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 17 (5.88%)	10 / 134 (7.46%)
occurrences all number	0	0	1	1	1	19
Anal abscess
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	1	0	0
Conjunctivitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 17 (11.76%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	2	0
Dermatophytosis of nail
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Pharyngotonsillitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 17 (0.00%)	0 / 134 (0.00%)
occurrences all number	0	0	1	0	0	0
Rhinitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Tonsillitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 17 (5.88%)	0 / 134 (0.00%)
occurrences all number	0	0	0	0	1	0
Influenza
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	16 / 134 (11.94%)
occurrences all number	0	0	0	0	0	18
Gastroenteritis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	8 / 134 (5.97%)
occurrences all number	0	0	0	0	0	9
Pharyngitis
subjects affected / exposed	0 / 79 (0.00%)	0 / 78 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 17 (0.00%)	7 / 134 (5.22%)
occurrences all number	0	0	0	0	0	8

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Induction phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

Primary: Induction phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

Primary: Maintenance Phase: Percentage of Participants with Clinical Remission

Primary: Maintenance Phase: Percentage of Participants with Clinical Remission

Primary: Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)

Primary: Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)

Primary: Number of Participants with TEAE Related to Body Weight (Weight Decreased)

Primary: Number of Participants with TEAE Related to Body Weight (Weight Decreased)

Primary: Number of Participants with TEAE Related to Vital Signs

Primary: Number of Participants with TEAE Related to Vital Signs

Primary: Number of Participants with TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]

Primary: Number of Participants with TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]

Primary: Number of Participants with Markedly Abnormal Values of Laboratory Parameters Values

Primary: Number of Participants with Markedly Abnormal Values of Laboratory Parameters Values

Secondary: Induction phase: Percentage of Participants with Clinical Remission

Secondary: Induction phase: Percentage of Participants with Clinical Remission

Secondary: Induction phase: Change from Baseline in C-reactive Protein (CRP) Values

Secondary: Induction phase: Change from Baseline in C-reactive Protein (CRP) Values

Secondary: Maintenance Phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

Secondary: Maintenance Phase: Percentage of Participants with Crohn's Disease Activity Index (CDAI)-100 Response

Secondary: Maintenance Phase: Percentage of Participants with Durable Clinical Remission

Secondary: Maintenance Phase: Percentage of Participants with Durable Clinical Remission

Secondary: Maintenance Phase: Percentage of Participants with Corticosteroid-free Clinical Remission

Secondary: Maintenance Phase: Percentage of Participants with Corticosteroid-free Clinical Remission

Secondary: Serum Vedolizumab Concentration in Induction Phase

Secondary: Serum Vedolizumab Concentration in Induction Phase

Secondary: Serum Vedolizumab Concentration in Maintenance Phase

Secondary: Serum Vedolizumab Concentration in Maintenance Phase

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Induction Phase

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Induction Phase

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

Secondary: Number of Participants with Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

Secondary: Number of Participants with Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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