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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02611830
Registration number
NCT02611830
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015
Date last updated
25/05/2022
Titles & IDs
Public title
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
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Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
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Secondary ID [1]
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2015-000480-14
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Secondary ID [2]
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MLN0002SC-3027
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab 300 mg IV
Treatment: Drugs - Placebo IV
Treatment: Drugs - Vedolizumab 108 mg SC
Treatment: Drugs - Placebo SC
Experimental: Maintenance Phase: Induction IV + Vedolizumab 108 mg SC - Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Experimental: Maintenance Phase: Induction IV + Vedolizumab 300 mg IV - Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Experimental: Maintenance Phase: Induction IV + Placebo - Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Treatment: Drugs: Vedolizumab 300 mg IV
Vedolizumab intravenous infusion
Treatment: Drugs: Placebo IV
Vedolizumab intravenous infusion placebo
Treatment: Drugs: Vedolizumab 108 mg SC
Vedolizumab subcutaneous injection
Treatment: Drugs: Placebo SC
Vedolizumab subcutaneous injection placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 52
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Assessment method [1]
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Clinical remission is defined as a complete Mayo score = 2 points and no individual subscore > 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Mucosal Healing at Week 52
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Assessment method [1]
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Mucosal healing is defined as Mayo endoscopic subscore =1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
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Assessment method [2]
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Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of =3 points and =30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
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Timepoint [2]
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Baseline, Weeks 6 and 52
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Secondary outcome [3]
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Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
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Assessment method [3]
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Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (=) 2 points and no individual subscore greater than (>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
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Timepoint [3]
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Weeks 6 and 52
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Secondary outcome [4]
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Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
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Assessment method [4]
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Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of = 2 points and no individual subscore > 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
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Timepoint [4]
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Week 52
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Eligibility
Key inclusion criteria
1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening,
by clinical and endoscopic evidence and corroborated by a histopathology report.
2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with
an endoscopic subscore =2)
3. Evidence of UC extending proximal to the rectum (=15 cm of involved colon).
4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
immunomodulators, or Tumor Necrosis Factor-alpha (TNF-a) antagonists
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
2. Extensive colonic resection, subtotal or total colectomy.
3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
4. Prior exposure to investigational or approved non-biologic therapies (eg,
cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment
of underlying disease within 30 days or 5 half-lives of screening (whichever is
longer).
5. Prior exposure to any investigational or approved biologic or biosimilar agent within
60 days or 5 half-lives of screening (whichever is longer).
6. Prior exposure to vedolizumab
7. Surgical intervention for UC required at any time during the study.
8. History or evidence of adenomatous colonic polyps that have not been removed or has a
history or evidence of colonic mucosal dysplasia.
9. Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis,
ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
microscopic colitis.
10. Active infections
11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
infection, HIV or tuberculosis (active or latent), identified congenital or acquired
immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen
[HBsAg] negative and hepatitis B antibody positive) may, however, be included.
12. History of any major neurological disorders, including stroke, multiple sclerosis,
brain tumor, demyelinating or neurodegenerative disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/08/2018
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Sample size
Target
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Accrual to date
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Final
383
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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The Alfred Hospital - Melbourne
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2139 - Concord
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2747 - Kingswood
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4102 - Woolloongabba
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3181 - Melbourne
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Recruitment outside Australia
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Nitra
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Country [109]
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Slovakia
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State/province [109]
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Presov
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Country [110]
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Spain
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State/province [110]
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Madrid
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Country [111]
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Spain
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State/province [111]
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Pontevedra
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Country [112]
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Sweden
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State/province [112]
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Stockholm
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Country [113]
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Turkey
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State/province [113]
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Ankara
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Country [114]
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Turkey
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State/province [114]
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Istanbul
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Country [115]
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Ukraine
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State/province [115]
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Chernivtsi
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Country [116]
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Ukraine
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State/province [116]
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Dnipro
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Country [117]
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Ukraine
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State/province [117]
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Ivano-Frankivsk
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Country [118]
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Ukraine
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State/province [118]
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Kharkiv
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Country [119]
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Ukraine
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Kherson
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Country [120]
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Country [122]
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Ukraine
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State/province [122]
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Devon
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Country [126]
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United Kingdom
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Greater London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Ethics approval
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Summary
Brief summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab
SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to
severely active ulcerative colitis (UC) who achieved clinical response following
administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02611830
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Public notes
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Contacts
Principal investigator
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Medical Director Clinical Science
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Address
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02611830
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