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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01177228
First received: August 5, 2010
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: Vedolizumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with active ulcerative colitis were randomized in a 4:1 ratio of vedolizumab to placebo.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo     Vedolizumab 2 mg/kg     Vedolizumab 6 mg/kg     Vedolizumab 10 mg/kg  
STARTED     9     13     14     11  
Received Treatment     9     12     14     11  
COMPLETED     8     11     14     11  
NOT COMPLETED     1     2     0     0  
Positive tuberculosis test                 0                 1                 0                 0  
Worsening disease activity                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline measures are reported for the Safety Analysis Set - 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.

Reporting Groups
  Description
Placebo Vedolizumab-matching placebo, intravenous (IV), one 30-minute 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.
Total Total of all reporting groups

Baseline Measures
    Placebo     Vedolizumab 2 mg/kg     Vedolizumab 6 mg/kg     Vedolizumab 10 mg/kg     Total  
Number of Participants  
[units: participants]
  9     12     14     11     46  
Age  
[units: years]
Mean ± Standard Deviation
  34.2  ± 8.11     39.0  ± 6.06     44.4  ± 12.37     44.3  ± 14.99     41.0  ± 11.46  
Gender  
[units: participants]
         
Female     6     8     7     6     27  
Male     3     4     7     5     19  
Race/Ethnicity, Customized  
[units: participants]
         
White, Not Hispanic or Latino     9     12     14     11     46  
Height  
[units: cm]
Mean ± Standard Deviation
  168.0  ± 7.33     169.8  ± 10.52     167.9  ± 9.87     170.7  ± 8.15     169.1  ± 9.00  
Weight  
[units: kg]
Mean ± Standard Deviation
  74.01  ± 24.04     75.76  ± 20.98     79.61  ± 16.65     73.46  ± 13.60     76.04  ± 18.38  
Body Mass Index (BMI)  
[units: kg/m²]
Mean ± Standard Deviation
  26.22  ± 8.46     26.03  ± 5.58     28.51  ± 6.66     25.29  ± 5.07     26.64  ± 6.37  
Body Surface Area (BSA)  
[units: m²]
Mean ± Standard Deviation
  1.84  ± 0.31     1.88  ± 0.30     1.92  ± 0.21     1.86  ± 0.20     1.88  ± 0.25  
Time Since Onset of Symptoms  
[units: years]
Mean ± Standard Deviation
  3.92  ± 2.79     6.25  ± 5.00     6.85  ± 4.31     7.03  ± 10.13     6.16  ± 6.08  
Time Since Diagnosis  
[units: years]
Mean ± Standard Deviation
  2.29  ± 2.43     5.26  ± 4.92     5.38  ± 4.79     5.46  ± 9.72     4.76  ± 6.01  
Participants with Acute Exacerbations in Past 12 Months  
[units: participants]
         
Yes     9     12     13     9     43  
No     0     0     1     2     3  
Participants Hospitalized for UC in Past 12 Months  
[units: participants]
         
Yes     5     3     2     4     14  
No     4     9     12     7     32  
Participants with Ongoing Therapy for UC at Enrollment  
[units: participants]
         
Yes     9     11     13     9     42  
No     0     1     1     2     4  
Participants with Significant Medical Conditions in Past 6 Months  
[units: participants]
         
Yes     5     11     12     9     37  
No     4     1     2     2     9  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: From the first date of study drug administration through Day 253 ]

2.  Primary:   Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85   [ Time Frame: Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. ]

3.  Primary:   Cmin: Minimum Observed Plasma Concentration of Vedolizumab   [ Time Frame: Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing. ]

4.  Primary:   Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab   [ Time Frame: Days 0-14, Days 85-99, Days 85-141 ]

5.  Primary:   Terminal Phase Elimination Half-life (t½) of Vedolizumab   [ Time Frame: Pre-dose through Day 253 ]

6.  Primary:   Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker   [ Time Frame: 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 ]

7.  Primary:   Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker   [ Time Frame: 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 ]

8.  Primary:   Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker   [ Time Frame: 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 ]

9.  Primary:   Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Millennium Pharmaceuticals Inc
phone: 1-800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01177228     History of Changes
Other Study ID Numbers: C13002, U1111-1156-8540
Study First Received: August 5, 2010
Results First Received: June 19, 2014
Last Updated: June 19, 2014
Health Authority: Canada: Health Canada
Russia: Pharmacological Committee, Ministry of Health