Clinical Trials Register

Summary
EudraCT Number:	2008-002782-32
Sponsor's Protocol Code Number:	C13006
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-01-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2008-002782-32

A.3

Full title of the trial

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

C13006

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MILLENNIUM PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Vedolizumab
D.3.2	Product code	MLN0002
D.3.4	Pharmaceutical form	Powder for infusion*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vedolizumab
D.3.9.1	CAS number	943609-66-3
D.3.9.2	Current sponsor code	MLN0002
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for infusion*
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with Moderate to Severe Ulcerative Colitis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10009900
E.1.2	Term	Colitis ulcerative

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

For the Induction Phase: To determine the effect of MLN0002 induction treatment on clinical response at 6 weeks.
For the Maintenance Phase:
To determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks.

E.2.2

Secondary objectives of the trial

for the Induction Phase
To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks
To determine the effect of MLN0002 induction treatment on mucosal healing at 6 weeks.
Secondary Objectives for the Maintenance Phase
To determine the effect of MLN0002 maintenance treatment on durability of clinical response
To determine the effect of MLN0002 maintenance treatment on mucosal healing at 52 weeks
To determine the effect of MLN0002 maintenance treatment on durability of clinical remission
To determine the effect of MLN0002 maintenance treatment on corticosteroid-free remission at 52 weeks

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

ALTRI SOTTOSTUDI: Sottostudio opzionale di farmacogenomica

E.3

Principal inclusion criteria

1. Age 18 to 80
2. Male or female patient who is voluntarily able to give informed consent
3. Female patients who:
Are post-menopausal for at least 1 year before the screening visit, 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
study drug through 6 months after the last dose of study drug, 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 study drug, OR
Agree to completely abstain from heterosexual intercourse.
4. Diagnosis of ulcerative colitis established at least 6 months prior to enrollment
by clinical and endoscopic evidence and corroborated by a histopathology
report.
5. Moderately to severely active ulcerative colitis as determined by a Mayo score
of 6 to 12 with an endoscopic subscore &#8805;2 within 7 days prior to the first dose
of study drug (see Section 15.1)
6. Evidence of ulcerative colitis extending proximal to the rectum (&#8805;15 cm of
involved colon)
7. 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 the initial
screening visit (may be performed during screening).
8. 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 (may be performed during screening).See protocol pp.39-41)

E.4

Principal exclusion criteria

General Exclusion Criteria
1. Previous exposure to MLN0002
2. Female patients who are lactating or have a positive serum pregnancy test
during the screening period or a positive urine pregnancy test on Day 1 prior to
study drug administration.
3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, genitourinary, hematological, coagulation, immunological,
endocrine/metabolic, or other medical disorder that, in the opinion of the
investigator, would confound the 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, except for the following: (a) adequately-treated
non-metastatic basal cell skin cancer; (b) any other type of non-melanoma skin
cancer that has been adequately treated and has not recurred for at least 1 year
prior to enrollment; and (c) adequately treated in situ cervical cancer that has
not recurred for at least 1 year prior to enrollment
6. History of any major neurological disorders, including stroke, multiple
sclerosis, brain tumor, or neurodegenerative disease
7. Positive PML subjective symptom checklist prior to the administration of the
first dose of study drug
8. Any of the following laboratory abnormalities during the screening period:
a. Hemoglobin level <8 g/dL
b. WBC count <3 × 109/L
c. Lymphocyte count <0.5 × 109/L
d. Platelet count <100 × 109/L or >1200 × 109/L. (See protocol pp. 41-44)

E.5 End points

E.5.1

Primary end point(s)

For the Induction Phase: Proportion of patients with clinical response at Week 6.
For the Maintenance Phase: proportion of patients in clinical remission at Week 52.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

116

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Settimana 52 o Early Termination Visit valutazioni di sicurezza ed efficacia)
Visita della Settimana 66 (valutazioni di sicurezza)

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

277

F.4.2.2

In the whole clinical trial

826

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

I pazienti potrebbero essere idonei per la partecipazione ad uno studio clinico in aperto di long-term safety: C13008. I pazienti che non parteciperanno a questa sperimentazione saranno monitorati con una visita di follow-up telefonico 12 settimane dopo aver ricevuto l`ultima dose di farmaco in studio. In aggiunta i pazienti che non saranno arruolati nello studio C13008 parteciperanno ad un follow-uo di 2 anni.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-11-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-12

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