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

A Phase 2 study testing Vedolizumab in people with Ulcerative Colitis, run by Millennium Pharmaceuticals, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Vedolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: No sites listed yet
Study dates: May 2007to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Each patient must meet all of the following inclusion criteria to be enrolled in the study.
Males or non-pregnant, non-lactating females voluntarily able to give informed consent
All patients must agree to use 2 effective forms of contraception from screening to the end of the study
Negative surveillance colonoscopy within the last 6 months if indicated by standard clinical practice guidelines
Confirmed and active ulcerative colitis (UC)
Partial Mayo Score 1 - 7
Disease involvement extending proximal to the rectum
May be receiving a therapeutic dose of conventional therapies for UC as defined by the protocol

Who cannot join

Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Patients who require ulcerative colitis (UC) surgical intervention or for whom surgical intervention is anticipated during the study
Patients who fail to meet laboratory values as specified in the protocol or have a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during the screening period
Low-grade dysplasia, high-grade dysplasia, dysplasia-associated lesion or mass, or colorectal cancer
Treatment with cyclosporine, FK506 (tacrolimus) or infliximab within 60 days prior to study
Patients receiving any of the following within 14-days prior to the study: antibiotics for treatment of irritable bowel syndrome, heparin or warfarin, narcotics, tube feeding, defined formula diets or parenteral alimentation

Show all 19Show fewer

Colostomy, fistulae or known fixed symptomatic stenosis of the intestine
Immunologic or ischemic intestinal condition
Toxic megacolon
Chronic hepatitis B or C or human immunodeficiency virus (HIV) infection
Any vaccinations within 30 days prior to study drug administration
History of imaging abnormalities, multiple sclerosis (MS), brain tumor or neurodegenerative disease
Significantly impaired liver or renal function
Current or recent history of alcohol dependence
Current use of illicit drugs
Active or recent serious infections or serious underlying disease as specified in protocol
Active psychiatric problems that might interfere with compliance to study
Previous exposure to MLN0002
Participated in an investigational study within 30 days prior to study drug administration or received treatment with an investigational monoclonal antibody within the last 6 months

About this study

Official title: A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Read the detailed description

At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections [including progressive multifocal leukoencephalopathy (PML)], and dysplasia/cancer.

Conditions: Ulcerative Colitis
Being tested: Vedolizumab, Placebo
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VedolizumabDrug
Also called Entyvio, MLN0002, MLN02, LDP-02
Vedolizumab for intravenous infusion
PlaceboDrug
Placebo intravenous infusion

Study groups in NCT01177228
Study group	Role	What they receive
Placebo	Placebo comparator	Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. Receives: Drug: Placebo
Vedolizumab 2 mg/kg	Experimental	Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. Receives: Drug: Vedolizumab
Vedolizumab 6 mg/kg	Experimental	Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. Receives: Drug: Vedolizumab
Vedolizumab 10 mg/kg	Experimental	Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85. Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
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.
Measured: From the first date of study drug administration through Day 253
Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.
Cmin: Minimum Observed Plasma Concentration of Vedolizumab
Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.
Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab
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
Measured: Days 0-14, Days 85-99, Days 85-141
Terminal Phase Elimination Half-life (t½) of Vedolizumab
Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
Measured: Pre-dose through Day 253
Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker
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.
Measured: 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
Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker
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.
Measured: 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
Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker
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.
Measured: 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
Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Sep 2008

First posted6 Aug 2010 (estimated)
Study startMay 2007
Primary completionJun 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177228
Sponsor's protocol ID: C13002
Other IDs: U1111-1156-8540
Status last verified: Jun 2014
First submitted: 5 Aug 2010
Last updated: 18 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
PubMed 26893500
Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
PubMed 25996351

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
ClinicalTrials.gov ID: NCT01177228
Acronym / sponsor ID: C13002
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jun 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Posted 18 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboVedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85.
Vedolizumab 2 mg/kg	Experimental	Drug: VedolizumabVedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
Vedolizumab 6 mg/kg	Experimental	Drug: VedolizumabVedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
Vedolizumab 10 mg/kg	Experimental	Drug: VedolizumabVedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Each patient must meet all of the following inclusion criteria to be enrolled in the study.
Males or non-pregnant, non-lactating females voluntarily able to give informed consent
All patients must agree to use 2 effective forms of contraception from screening to the end of the study
Negative surveillance colonoscopy within the last 6 months if indicated by standard clinical practice guidelines
Confirmed and active ulcerative colitis (UC)

Key exclusion criteria (19 listed)

Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Patients who require ulcerative colitis (UC) surgical intervention or for whom surgical intervention is anticipated during the study
Patients who fail to meet laboratory values as specified in the protocol or have a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during the screening period
Low-grade dysplasia, high-grade dysplasia, dysplasia-associated lesion or mass, or colorectal cancer
Treatment with cyclosporine, FK506 (tacrolimus) or infliximab within 60 days prior to study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VedolizumabAlso: Entyvio, MLN0002, MLN02, LDP-02Vedolizumab for intravenous infusion	Drug	Vedolizumab 10 mg/kg, Vedolizumab 2 mg/kg, Vedolizumab 6 mg/kg
PlaceboPlacebo intravenous infusion	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: From the first date of study drug administration through Day 253
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.
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.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Cmin: Minimum Observed Plasma Concentration of Vedolizumab
Time frame: Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.
Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab
Time frame: Days 0-14, Days 85-99, Days 85-141
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
Terminal Phase Elimination Half-life (t½) of Vedolizumab
Time frame: Pre-dose through Day 253
Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
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
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.
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
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.
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
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.
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
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.

Results and safety

Results posted to the registry on 18 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	9	8
Vedolizumab 2 mg/kg	13	11
Vedolizumab 6 mg/kg	14	14
Vedolizumab 10 mg/kg	11	11

Primary outcome: Number of Participants With Adverse Events

Time frame: From the first date of study drug administration through Day 253. Number. Unit: participants

Measure	Placebo n = 9	Vedolizumab 2 mg/kg n = 12	Vedolizumab 6 mg/kg n = 14	Vedolizumab 10 mg/kg n = 11
Any Adverse Event	7	9	9	6
Severe Adverse Event	0	0	1	1
Drug-related Adverse Event	3	2	1	1
Serious Adverse Event	0	1	0	1
Drug-related Serious Adverse Event	0	0	0	0
Serious Adverse Event Resulting in Discontinuation	0	0	0	0
On-study Deaths	0	0	0	0

Population analysed: 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.

Primary outcome: 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.. Mean (Standard Deviation). Unit: µg/mL

Measure	Vedolizumab 2 mg/kg n = 10	Vedolizumab (6 mg/kg) n = 14	Vedolizumab 10 mg/kg n = 11
Cmax, Day 1 (n=10, 14, 11)	54.0 (8.9)	154.3 (41.5)	279.0 (167.9)
Cmax, Day 85 (n=9, 14, 11)	60.4 (12.5)	191.9 (42.6)	291.9 (95.0)

Population analysed: 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").

Primary outcome: Cmin: Minimum Observed Plasma Concentration of Vedolizumab

Time frame: Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.. Mean (Standard Deviation). Unit: μg/mL

Measure	Vedolizumab 2 mg/kg n = 9	Vedolizumab 6 mg/kg n = 14	Vedolizumab 10 mg/kg n = 11
Value	7.25 (2.41)	29.33 (13.36)	44.74 (19.80)

Population analysed: PK Analysis Set; participants with available data.

Primary outcome: Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab

Time frame: Days 0-14, Days 85-99, Days 85-141. Mean (Standard Deviation). Unit: day*μg/mL

Measure	Vedolizumab 2 mg/kg n = 10	Vedolizumab 6 mg/kg n = 14	Vedolizumab 10 mg/kg n = 11
AUC (Day 0-14) (n=10, 14, 11)	375 (59)	1058 (270)	1765 (822)
AUC(Day 85-99) (n=9, 14, 11)	473 (92)	1532 (227)	2608 (795)
AUC(Day 85-141) (n=9, 14, 11)	1082 (243)	3318 (698)	5633 (1927)

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

Adverse events

Time frame: Adverse events were collected through Day 253 or the final study visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
Vedolizumab 2 mg/kg	1 of 12 (8.3%)	9 of 12 (75%)	Not reported
Vedolizumab 6 mg/kg	0 of 14 (0%)	9 of 14 (64.3%)	Not reported
Vedolizumab 10 mg/kg	1 of 11 (9.1%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26893500Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
Derived from this study: PubMed 25996351Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.

Related trials for Ulcerative Colitis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vedolizumab in people with Ulcerative Colitis, run by Millennium Pharmaceuticals, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: From the first date of study drug administration through Day 253). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01177228, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.