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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02497469




Registration number
NCT02497469
Ethics application status
Date submitted
10/07/2015
Date registered
14/07/2015
Date last updated
28/01/2020

Titles & IDs
Public title
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Scientific title
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
U1111-1168-6713
Secondary ID [2] 0 0
MLN0002-3026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab
Treatment: Drugs - Adalimumab placebo
Treatment: Drugs - Adalimumab
Treatment: Drugs - Vedolizumab placebo

Experimental: Vedolizumab IV 300 mg - Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.

Active Comparator: Adalimumab SC 160/80/40 mg - Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.


Treatment: Drugs: Vedolizumab
Vedolizumab infusion

Treatment: Drugs: Adalimumab placebo
Adalimumab placebo-matching injection

Treatment: Drugs: Adalimumab
Adalimumab injection

Treatment: Drugs: Vedolizumab placebo
Vedolizumab placebo-matching infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission - Clinical remission was defined as a complete Mayo score of =2 points and no individual subscore >1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Mucosal Healing - Mucosal healing was defined as a Mayo score endoscopic subscore of <= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission - Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of = 2 points and no individual subscore > 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Timepoint [2] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screening
by clinical and endoscopic evidence and corroborated by a histopathology report.

2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of
6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior
to the randomization.

3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of
involved colon).

4. With extensive colitis (up to the hepatic flexure) 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 the Screening Period).

5. The participant:

1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha)
antagonists without documented clinical response to treatment (example, due to
lack of response [primary nonresponders], loss of response, or intolerance
[secondary nonresponders]), or

2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued
its use due to reasons other than safety, or

3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment
(example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.

2. Has had an extensive colonic resection, subtotal or total colectomy.

3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis,
radiation colitis, diverticular disease associated with colitis, or microscopic
colitis.

5. Has received any of the following for the treatment of underlying disease within 30
days of randomization:

1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other
than those specifically listed in Section Permitted Medications For Treatment of
UC.

2. An approved non-biologic therapy in an investigational protocol.

6. Has received any investigational or approved biologic or biosimilar agent within 60
days or 5 half lives prior to the screening (whichever is longer).

7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal
addressin cell adhesion molecule-1 antibodies, or rituximab.

8. Has previously received vedolizumab.

9. Has history or evidence of adenomatous colonic polyps that have not been removed, or
colonic mucosal dysplasia.

10. Evidence of an active infection during Screening.

11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other
intestinal pathogen within 28 days prior to the 1st dose of study drug.

12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV)
infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg],
may participate).

13. Has active or latent TB, regardless of treatment history.

14. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid
enemas/suppositories within 2 weeks of the administration of the 1st dose of study
drug.

15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist prior to the administration of the first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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Concord Repatriation General Hospital - Concord
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Royal Adelaide Hospital - Adelaide
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Tennyson Centre Day Hospital - Bedford Park
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Moorabbin - Clayton
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St Frances Xavier Cabrini Hospital - Malvern
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2139 - Concord
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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5042 - Bedford Park
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3350 - Ballarat
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3168 - Clayton
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3144 - Malvern
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Ukraine
State/province [191] 0 0
Dnipropetrovsk
Country [192] 0 0
Ukraine
State/province [192] 0 0
Ivano-Frankivsk
Country [193] 0 0
Ukraine
State/province [193] 0 0
Kharkiv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Kherson
Country [195] 0 0
Ukraine
State/province [195] 0 0
Kirovohrad
Country [196] 0 0
Ukraine
State/province [196] 0 0
Kyiv
Country [197] 0 0
Ukraine
State/province [197] 0 0
Lviv
Country [198] 0 0
Ukraine
State/province [198] 0 0
Odesa
Country [199] 0 0
Ukraine
State/province [199] 0 0
Uzhgorod
Country [200] 0 0
Ukraine
State/province [200] 0 0
Vinnytsia
Country [201] 0 0
Ukraine
State/province [201] 0 0
Zaporizhzhia
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Devon
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Greater Manchester
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Norfolk
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Strathclyde
Country [206] 0 0
United Kingdom
State/province [206] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous
(IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment
period.
Trial website
https://clinicaltrials.gov/show/NCT02497469
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications