Trial Outcomes & Findings for Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis (NCT NCT01177228)

Last Updated: 2014-07-18

Results Overview

An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

From the first date of study drug administration through Day 253

Results posted on

2014-07-18

Participant Flow

Participants took part in the study at 2 study centers in Canada and 9 study centers in Russia, from 02 May 2007 to 16 June 2008.

Participants with active ulcerative colitis were randomized in a 4:1 ratio of vedolizumab to placebo.

Participant milestones

Participant milestones
Measure	Placebo Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
Overall Study STARTED	9	13	14	11
Overall Study Received Treatment	9	12	14	11
Overall Study COMPLETED	8	11	14	11
Overall Study NOT COMPLETED	1	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
Overall Study Positive tuberculosis test	0	1
Overall Study Worsening disease activity	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=12 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=14 Participants Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.	Total n=46 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 8.11 • n=5 Participants	39.0 years STANDARD_DEVIATION 6.06 • n=7 Participants	44.4 years STANDARD_DEVIATION 12.37 • n=5 Participants	44.3 years STANDARD_DEVIATION 14.99 • n=4 Participants	41.0 years STANDARD_DEVIATION 11.46 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized White, Not Hispanic or Latino	9 participants n=5 Participants	12 participants n=7 Participants	14 participants n=5 Participants	11 participants n=4 Participants	46 participants n=21 Participants
Height	168.0 cm STANDARD_DEVIATION 7.33 • n=5 Participants	169.8 cm STANDARD_DEVIATION 10.52 • n=7 Participants	167.9 cm STANDARD_DEVIATION 9.87 • n=5 Participants	170.7 cm STANDARD_DEVIATION 8.15 • n=4 Participants	169.1 cm STANDARD_DEVIATION 9.00 • n=21 Participants
Weight	74.01 kg STANDARD_DEVIATION 24.04 • n=5 Participants	75.76 kg STANDARD_DEVIATION 20.98 • n=7 Participants	79.61 kg STANDARD_DEVIATION 16.65 • n=5 Participants	73.46 kg STANDARD_DEVIATION 13.60 • n=4 Participants	76.04 kg STANDARD_DEVIATION 18.38 • n=21 Participants
Body Mass Index (BMI)	26.22 kg/m² STANDARD_DEVIATION 8.46 • n=5 Participants	26.03 kg/m² STANDARD_DEVIATION 5.58 • n=7 Participants	28.51 kg/m² STANDARD_DEVIATION 6.66 • n=5 Participants	25.29 kg/m² STANDARD_DEVIATION 5.07 • n=4 Participants	26.64 kg/m² STANDARD_DEVIATION 6.37 • n=21 Participants
Body Surface Area (BSA)	1.84 m² STANDARD_DEVIATION 0.31 • n=5 Participants	1.88 m² STANDARD_DEVIATION 0.30 • n=7 Participants	1.92 m² STANDARD_DEVIATION 0.21 • n=5 Participants	1.86 m² STANDARD_DEVIATION 0.20 • n=4 Participants	1.88 m² STANDARD_DEVIATION 0.25 • n=21 Participants
Time Since Onset of Symptoms	3.92 years STANDARD_DEVIATION 2.79 • n=5 Participants	6.25 years STANDARD_DEVIATION 5.00 • n=7 Participants	6.85 years STANDARD_DEVIATION 4.31 • n=5 Participants	7.03 years STANDARD_DEVIATION 10.13 • n=4 Participants	6.16 years STANDARD_DEVIATION 6.08 • n=21 Participants
Time Since Diagnosis	2.29 years STANDARD_DEVIATION 2.43 • n=5 Participants	5.26 years STANDARD_DEVIATION 4.92 • n=7 Participants	5.38 years STANDARD_DEVIATION 4.79 • n=5 Participants	5.46 years STANDARD_DEVIATION 9.72 • n=4 Participants	4.76 years STANDARD_DEVIATION 6.01 • n=21 Participants
Participants with Acute Exacerbations in Past 12 Months Yes	9 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	9 participants n=4 Participants	43 participants n=21 Participants
Participants with Acute Exacerbations in Past 12 Months No	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Participants Hospitalized for UC in Past 12 Months Yes	5 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	14 participants n=21 Participants
Participants Hospitalized for UC in Past 12 Months No	4 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants	7 participants n=4 Participants	32 participants n=21 Participants
Participants with Ongoing Therapy for UC at Enrollment Yes	9 participants n=5 Participants	11 participants n=7 Participants	13 participants n=5 Participants	9 participants n=4 Participants	42 participants n=21 Participants
Participants with Ongoing Therapy for UC at Enrollment No	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Participants with Significant Medical Conditions in Past 6 Months Yes	5 participants n=5 Participants	11 participants n=7 Participants	12 participants n=5 Participants	9 participants n=4 Participants	37 participants n=21 Participants
Participants with Significant Medical Conditions in Past 6 Months No	4 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants

PRIMARY outcome

Timeframe: From the first date of study drug administration through Day 253

Population: Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=12 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=14 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Number of Participants With Adverse Events On-study Deaths	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Any Adverse Event	7 participants	9 participants	9 participants	6 participants
Number of Participants With Adverse Events Severe Adverse Event	0 participants	0 participants	1 participants	1 participants
Number of Participants With Adverse Events Drug-related Adverse Event	3 participants	2 participants	1 participants	1 participants
Number of Participants With Adverse Events Serious Adverse Event	0 participants	1 participants	0 participants	1 participants
Number of Participants With Adverse Events Drug-related Serious Adverse Event	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Serious Adverse Event Resulting in Discontinuation	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.

Population: Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by "n").

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=14 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 Cmax, Day 1 (n=10, 14, 11)	54.0 µg/mL Standard Deviation 8.9	154.3 µg/mL Standard Deviation 41.5	279.0 µg/mL Standard Deviation 167.9	—
Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 Cmax, Day 85 (n=9, 14, 11)	60.4 µg/mL Standard Deviation 12.5	191.9 µg/mL Standard Deviation 42.6	291.9 µg/mL Standard Deviation 95.0	—

PRIMARY outcome

Timeframe: Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.

Population: PK Analysis Set; participants with available data.

Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=14 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Cmin: Minimum Observed Plasma Concentration of Vedolizumab	7.25 μg/mL Standard Deviation 2.41	29.33 μg/mL Standard Deviation 13.36	44.74 μg/mL Standard Deviation 19.80	—

PRIMARY outcome

Timeframe: Days 0-14, Days 85-99, Days 85-141

Population: PK Analysis Set; participants with available data at each time point (indicated by "n").

AUC was calculated for 3 time intervals during the study: 1. AUC (Day 0-14): from administration on Day 0 to last quantifiable concentration on Day 14, selected to capture the AUC following the first dose of vedolizumab until administration of the second dose 2. AUC(Day 85-99): from administration on Day 85 to last quantifiable concentration on Day 99, selected to assess the amount of drug accumulation with the planned loading regimen by comparing it to AUC(Day 0-14) 3. AUC(Day 85-141): from the first quantifiable concentration on Day 85 to the last quantifiable concentration on Day 141, selected to assess the drug exposure over an 8-week period

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=14 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab AUC (Day 0-14) (n=10, 14, 11)	375 day*μg/mL Standard Deviation 59	1058 day*μg/mL Standard Deviation 270	1765 day*μg/mL Standard Deviation 822	—
Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab AUC(Day 85-99) (n=9, 14, 11)	473 day*μg/mL Standard Deviation 92	1532 day*μg/mL Standard Deviation 227	2608 day*μg/mL Standard Deviation 795	—
Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab AUC(Day 85-141) (n=9, 14, 11)	1082 day*μg/mL Standard Deviation 243	3318 day*μg/mL Standard Deviation 698	5633 day*μg/mL Standard Deviation 1927	—

PRIMARY outcome

Timeframe: Pre-dose through Day 253

Population: PK Analysis Set; participants with available data

Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=14 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Terminal Phase Elimination Half-life (t½) of Vedolizumab	15.1 days Standard Deviation 2.0	22.0 days Standard Deviation 6.7	20.6 days Standard Deviation 7.2	—

PRIMARY outcome

Timeframe: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253

Population: Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by "n").

The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85 and based on all available data.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=10 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=12 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker Day 1 (n=8, 10, 12, 11)	18.4 percent inhibition Standard Deviation 19.3	98.0 percent inhibition Standard Deviation 1.1	99.0 percent inhibition Standard Deviation 0.8	98.3 percent inhibition Standard Deviation 1.3
Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker Day 85 (n=8, 9, 12, 11)	22.8 percent inhibition Standard Deviation 15.3	98.7 percent inhibition Standard Deviation 1.2	99.1 percent inhibition Standard Deviation 0.7	98.6 percent inhibition Standard Deviation 0.8
Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker All available (n=8, 10, 12, 11)	56.3 percent inhibition Standard Deviation 29.4	99.5 percent inhibition Standard Deviation 0.6	99.8 percent inhibition Standard Deviation 0.3	99.8 percent inhibition Standard Deviation 0.3

PRIMARY outcome

Timeframe: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253

Population: PD Analysis Set; participants with available data (indicated by "n")

The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding. Emax was calculated on Day 1, Day 85, and based on all available data.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=10 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=10 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker Day 1 (n=8, 10, 11, 10)	11.9 percent inhibition Standard Deviation 15.3	96.4 percent inhibition Standard Deviation 1.8	89.8 percent inhibition Standard Deviation 29.8	96.8 percent inhibition Standard Deviation 2.9
Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker Day 85 (n=8, 9, 11, 10)	8.5 percent inhibition Standard Deviation 7.9	98.3 percent inhibition Standard Deviation 1.1	98.3 percent inhibition Standard Deviation 2.3	96.2 percent inhibition Standard Deviation 2.6
Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker All available (n=8, 10, 11, 10)	43.3 percent inhibition Standard Deviation 27.3	99.3 percent inhibition Standard Deviation 0.6	99.8 percent inhibition Standard Deviation 0.3	99.3 percent inhibition Standard Deviation 0.7

PRIMARY outcome

Timeframe: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253

Population: PD Analysis Set; participants with available data (indicated by "n")

AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time \[AUEC(0-last)\] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=10 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=12 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker	4281.7 percent inhibition*days Standard Deviation 3035.3	20195.9 percent inhibition*days Standard Deviation 3814.2	22675.2 percent inhibition*days Standard Deviation 2211.8	23613.7 percent inhibition*days Standard Deviation 1574.4

PRIMARY outcome

Timeframe: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253

Population: PD Analysis Set; participants with available data (indicated by "n")

AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time \[AUEC(0-last)\] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=10 Participants Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=11 Participants Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=10 Participants Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker	2139.2 percent inhibition*days Standard Deviation 1513.4	18802.0 percent inhibition*days Standard Deviation 3556.1	22322.1 percent inhibition*days Standard Deviation 1974.2	22484.6 percent inhibition*days Standard Deviation 1716.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Vedolizumab 2 mg/kg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Vedolizumab 6 mg/kg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Vedolizumab 10 mg/kg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=9 participants at risk Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=12 participants at risk Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=14 participants at risk Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 participants at risk Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.

Other adverse events

Additional Information

Medical Director

Millennium Pharmaceuticals Inc

Phone: 1-800-778-2860

Email: [email protected]

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

Measure	Placebo n=9 participants at risk Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.	Vedolizumab 2 mg/kg n=12 participants at risk Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 6 mg/kg n=14 participants at risk Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.	Vedolizumab 10 mg/kg n=11 participants at risk Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
Infections and infestations Upper respiratory tract infection	33.3% 3/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Nasopharyngitis	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	16.7% 2/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Gastroenteritis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Infectious mononucleosis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Laryngotracheitis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Pharyngitis streptococcal	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Pyelonephritis chronic	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Respiratory tract infection viral	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Sinusitis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Herpes zoster	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Lobar pneumonia	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Mastitis	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Infections and infestations Respiratory tract infection	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Colitis ulcerative	44.4% 4/9 • Adverse events were collected through Day 253 or the final study visit.	16.7% 2/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Constipation	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Anal discomfort	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Gastritis erosive	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Nausea	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Nervous system disorders Headache	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	16.7% 2/12 • Adverse events were collected through Day 253 or the final study visit.	21.4% 3/14 • Adverse events were collected through Day 253 or the final study visit.	18.2% 2/11 • Adverse events were collected through Day 253 or the final study visit.
Nervous system disorders Dizziness	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Nervous system disorders Balance disorder	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Investigations C-reactive protein increased	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Investigations Blood glucose increased	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Investigations Blood pressure increased	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Investigations Liver function test abnormal	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	14.3% 2/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Musculoskeletal and connective tissue disorders Tendonitis	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
General disorders Influenza like illness	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	14.3% 2/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
General disorders Pyrexia	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	14.3% 2/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
General disorders Chills	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Renal and urinary disorders Calculus urinary	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Renal and urinary disorders Nephrolithiasis	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	8.3% 1/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Vascular disorders Hypertension	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	9.1% 1/11 • Adverse events were collected through Day 253 or the final study visit.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	7.1% 1/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Blood and lymphatic system disorders Hypochromic anaemia	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast adenoma	11.1% 1/9 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/12 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/14 • Adverse events were collected through Day 253 or the final study visit.	0.00% 0/11 • Adverse events were collected through Day 253 or the final study visit.