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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 April 2017
Main ID:  EUCTR2014-003942-28-DE
Date of registration: 23/03/2016
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients with Inflammatory Bowel Disease
Scientific title: Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
Date of first enrolment: 09/05/2016
Target sample size: 258
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003942-28
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
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 Canada Czech Republic Denmark Finland France
Germany Hungary Israel Italy Japan Netherlands Poland Russian Federation
Spain Sweden Switzerland United Kingdom United States
Contacts
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: +44203116 8000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe Ltd
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: +44203116 8000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. The subject has chronic cholestatic liver disease, of at least 6 months duration, with a subsequent diagnosis of PSC, based on cholangiographic findings of intrahepatic and/or extrahepatic bile duct irregularities consistent with PSC.
4. The subject has a diagnosis of IBD (either UC, CD, or IBDU), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
5. The subject is male or female and aged 18 years and older, inclusive.
6. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the study and for 18 weeks after last dose.
7. A female subject of childbearing potential* who is sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 18 weeks after the last dose.
8. The subject has had a colorectal cancer screen within 12 months of the Screening Visit with no signs of malignancy, dysplasia, or neoplasia.
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 246
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
1. The subject has had previous exposure to vedolizumab
2. The subject has a history of hypersensitivity or allergies to vedolizumab
3. The subject has had previous exposure to natalizumab, efalizumab, rituximab or any other integrin antagonist
4. The subject has received any investigational or approved biologic or biosimilar agent
5. The subject has received any of the following for the treatment of underlying disease within 30 days of screening:
• Nonbiologic therapies other than those specifically listed in the protocol Section 7.3.1 Permitted Medications for the Treatment of IBD
• An approved nonbiologic therapy in an investigational protocol
6. The subject has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes
7. The subject has any history of malignancy, except for (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has not recurred for at least 1 year prior to randomization; and (c) history of cervical carcinoma in situ that has not recurred for at least 3 years prior to randomization
8. The subject has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demylelinating or neurodegenerative disease
9. The subject has a positive response on the PML subjective symptom checklist prior to the administration of study drug


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary Sclerosing Cholangitis (PSC) Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871
MedDRA version: 18.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To evaluate the efficacy and safety of vedolizumab IV in non–end-stage PSC subjects with underlying IBD
Primary end point(s): Proportion of subjects with no worsening in Ishak fibrosis staging score, from Baseline to the Week 106 visit
Secondary Objective: To evaluate the effect of vedolizumab IV on inflammation and alkaline phosphatase (ALP) in non–end-stage PSC subjects with underlying IBD
Timepoint(s) of evaluation of this end point: Week 106
Secondary Outcome(s)
Secondary end point(s): ? Proportion of subjects with a =35% reduction in serum ALP from Baseline to the Week 106 visit.
? Change in Ishak necroinflammatory grading score from the Baseline visit to the Week 106 visit.
Timepoint(s) of evaluation of this end point: Week 106
Secondary ID(s)
2014-003942-28-ES
MLN0002-3023
Source(s) of Monetary Support
Takeda Development Center Americas, Inc
Takeda Development Centre Europe Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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