A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2008-002784-14-IT
• Date of registration: 17/03/2009
• Prospective Registration: Yes
• Primary sponsor: MILLENNIUM PHARMACEUTICALS, INC.
• Public title: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND
• Scientific title: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND
• Date of first enrolment: 22/07/2009
• Target sample size: 1508
• 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: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Malta, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Voluntarily able to give informed consent.
2. Previous treatment in Study C13004, Study C13006 or Study C13007 that, in the
opinion of the investigator, was well tolerated. Patients who withdrew early from
C13006 or C13007 must have withdrawn due to one of the following:
Sustained Nonresponse for patients with UC in C13006: Failure to achieve a
clinical response (2 point and 25% improvement in partial Mayo score) by
Week 14 and a minimum partial Mayo score of ≥5 points
Sustained Nonresponse for patients with CD in C13007: Failure to achieve a
clinical response (70 point improvement in CDAI score) by Week 14 and a
minimum CDAI score of 220 points
Disease Worsening for patients with UC in C13006: An increase in partial
Mayo score of ≥3 points on 2 consecutive visits from the Week 6 value (or an
increase to 9 points on 2 consecutive visits if the Week 6 value >6) and a
minimum partial Mayo score of ≥5 points
Disease Worsening for patients with CD in C13007: A ≥100 point increase
in CDAI score on 2 consecutive visits from the Week 6 value at any study
visit and a minimum CDAI score of 220 points
Rescue medications for patients in C13006 and C13007: Any new medication
or any increase in dose of a baseline medication required to treat new or
unresolved UC or CD symptoms (other than antidiarrheals for control of
chronic diarrhea)
3. The first dose of MLN0002 in this study (ie, Week 0) must occur not more than
5 weeks after the last dose of study drug in the previous MLN0002 study.
4. Female patients who:
�� are post-menopausal for at least 1 year before enrollment, OR
�� are surgically sterile, OR
�� if they are of childbearing potential, agree to practice 2 effective methods of
contraception, at the same time, from four weeks before the first dose of MLN0002 through 6 months after the last dose of MLN0002, OR agree to
completely abstain from heterosexual intercourse.
Male patients, even if surgically sterilized (ie, status post-vasectomy), who:
�� agree to practice effective barrier contraception during the entire study
treatment period and through 6 months after the last dose of MLN0002, OR
�� agree to completely abstain from heterosexual intercourse.
5. Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis
of >12 years duration must have documented evidence that a surveillance
colonoscopy was performed within 12 months of enrollment.
6. Patients with a family history of colorectal cancer, personal history of increased
colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date
on colorectal cancer surveillance.
7. May be receiving a therapeutic dose of the following drugs:
a. Oral 5-ASA compounds
b. Oral corticosteroid therapy (prednisone at a stable dose ≤30 mg/day,
budesonide at a stable dose ≤9 mg/day, or equivalent steroid)
c. Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories
d. Probiotics (eg, Culturelle, Saccharomyces boulardii)
e. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea
f. Antibiotics used for the treatment of CD (ie, ciprofloxacin, metronidazole).
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
F.1.3 Elderly (>=65 y
Exclusion criteria:
1. Female patients who are lactating or pregnant
2. Required surgical intervention for IBD during or after participation in a prior MLN0002 study, currently requires surgical intervention for IBD, or is anticipated to require surgical intervention for IBD during this study.
3. Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine.
4. Development of any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation,
immunological, endocrine/metabolic, neurologic, oncologic, or other medical
disorder during or after participation in a prior MLN0002 study that, in the opinion of the investigator, would confound the study results or compromise patient safety.
5. Withdrawal from a previous MLN0002 study due to a study-drug related AE.
6. Active psychiatric or substance abuse problems that, in the investigator?s opinion, may interfere with compliance with the study procedures.
7. Unable to attend all the study visits or comply with study procedures.


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

Health Condition(s) or Problem(s) studied

Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD)
MedDRA version: 9.1 Level: LLT Classification code 10045282
MedDRA version: 9.1 Level: PT Classification code 10011401

Intervention(s)

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

Primary Outcome(s)

Main Objective: To determine the safety profile of long-term MLN0002 treatment

Primary end point(s): SAEs, AEs,segni vitali, risultati degli esami standard di laboratorio (chimica clinica, ematologia, coagulazione, esame delle urine, HAHA) e risultati degli elettrocardiogrammi.

Secondary Objective: To determine the effect of long-term MLN0002 treatment on time to major
inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and
procedures)
To examine 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

Secondary ID(s)

2008-002784-14-EE

C13008