"An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease"

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2008-002784-14-DE
• Date of registration: 02/06/2009
• Prospective Registration: Yes
• Primary sponsor: Takeda Development Centre Europe Ltd.
• Public title: "An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease"
• Scientific title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease
• Date of first enrolment: 02/09/2009
• Target sample size: 2200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002784-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Malaysia, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Programme Manager
• Affiliation: Takeda Development Centre Europe

• Name: Clinical Programme Manager
• Affiliation: Takeda Development Centre Europe

Key inclusion & exclusion criteria

Inclusion criteria:
Previous treatment in prior MLN0002 study that, in the opinion of the Investigator, was well tolerated; or de novo patients with appropriate diagnosis of ulcerative colitis or Crohn's disease that have demonstrated inadequate response, loss of response to, or intolerance of therapeutic agent (e.g. corticosteriods, immunomodulators, TNFa antagonists).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1812
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 388

Exclusion criteria:
Exclusion Criteria for Rollover Patients:

1. Female patients who are lactating or pregnant.
2. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period
3. Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine.
4. Any new, unstable or uncontrolled major medical conditions that
would confound study results or compromise patient safety
5. Withdrawal from a previous MLN0002 study due to a study-drug related AE.

General Exclusion Criteria for De Novo Patients:

1. Previous exposure to MLN0002
2. Female patients who are lactating or have a positive serum
3. Any new, unstable or uncontrolled major medical conditions that
would confound study results or compromise patient safety.
4. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period
5. Any history of malignancy
6. History of any major neurological disorders
7. Positive PML subjective symptom checklist prior to the administration of the first dose of study drug


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
MedDRA version: 17.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Intervention(s)

Product Name: VEDOLIZUMAB
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): Primary Endpoints

• SAEs, AEs, vital signs, standard laboratory tests (clinical chemistry, hematology, coagulation, urinalysis, and HAHA), and electrocardiograms (ECGs)

Secondary Objective: Resource Utilization and Patient Reported Outcome Objectives

• To determine the effect of long-term MLN0002 treatment on time to major IBD-related events (hospitalizations, surgeries, and IBD-related procedures)

• To determine the effect of long-term MLN0002 treatment on health-related quality of life (QOL) measurements


Exploratory Objective

• To obtain data regarding the effect of long-term MLN0002 treatment on maintaining clinical response and remission

Timepoint(s) of evaluation of this end point: Evaluated up to a maximum of 352 weeks or until vedolizumab (MLN0002) becomes available in the applicable country, whichever occurs first

Main Objective: Primary Objective

• To determine the safety profile of long-term MLN0002 treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: n/a

Secondary end point(s): n/a

Secondary ID(s)

NCT00790933

C13008

2008-002784-14-EE

Source(s) of Monetary Support

Takeda Development Centre Europe Ltd.