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

NCT ID: NCT01177228

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-09-30

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo intravenous infusion

Vedolizumab 2 mg/kg

Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab for intravenous infusion

Vedolizumab 6 mg/kg

Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab for intravenous infusion

Vedolizumab 10 mg/kg

Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab for intravenous infusion

Interventions

Vedolizumab

Vedolizumab for intravenous infusion

Intervention Type: DRUG

Placebo

Placebo intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Entyvio; MLN0002; MLN02; LDP-02

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

References

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.

Reference Type: DERIVED

PMID: 26893500 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25996351 (View on PubMed)

Other Identifiers

U1111-1156-8540

Identifier Type: REGISTRY

Identifier Source: secondary_id

C13002

Identifier Type: -

Identifier Source: org_study_id