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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02611830




Registration number
NCT02611830
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015

Titles & IDs
Public title
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
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
Secondary ID [1] 0 0
2015-000480-14
Secondary ID [2] 0 0
MLN0002SC-3027
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 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Mucosal Healing at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
Timepoint [2] 0 0
Baseline, Weeks 6 and 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
Timepoint [3] 0 0
Weeks 6 and 52
Secondary outcome [4] 0 0
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Timepoint [4] 0 0
Week 52

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 administering the treatment/s
The people assessing the outcomes
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
18/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2018
Sample size
Target
Accrual to date
Final
383
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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Missouri
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New York
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United States of America
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Ohio
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United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
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Washington
Country [19] 0 0
Argentina
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Ciudad Autonoma Buenos Aires
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Belgium
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Ottignies
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Belgium
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Roeselare
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Bosnia and Herzegovina
State/province [22] 0 0
Banja Luka
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Brazil
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Goias
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Brazil
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Rio Do Janeiro
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Brazil
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Sao Paulo
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Bulgaria
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Pleven
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Bulgaria
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Silistra
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Bulgaria
State/province [28] 0 0
Sliven
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Bulgaria
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Sofia
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Bulgaria
State/province [30] 0 0
Stara Zagora
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Canada
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Ontario
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Croatia
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Osijek
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Plzen
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Czechia
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Praha 3
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Czechia
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Praha 8
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Denmark
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Odense C
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Estonia
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Tallinn
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Germany
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Niedersachsen
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Germany
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Sachsen
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Germany
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Berlin
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Hungary
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Budapest
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Hungary
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Kistarcsa
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Hungary
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Mosonmagyarovar
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Hungary
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Szekesfehervar
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Hungary
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Szekszard
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Israel
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Holon
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Israel
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Ramat Gan
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Italy
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Foggia
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Japan
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Aichi-Ken
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Japan
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Chiba-Ken
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Japan
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Ehime-Ken
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Japan
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Fukuoka-Ken
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Japan
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Hiroshima-Ken
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Japan
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Hokkaido
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Japan
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Hyogo-Ken
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Japan
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Kagawa-Ken
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Japan
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Kanagawa-Ken
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Japan
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Okayama-Ken
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Japan
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Osaka-Fu
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Japan
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Saga-Ken
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Japan
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Shiga-Ken
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Japan
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Shizuoka-Ken
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Japan
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Tokyo-To
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Japan
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Wakayama-Ken
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Durango
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Mexico
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Veracruz
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Netherlands
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Amsterdam
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Netherlands
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Dordrecht
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Netherlands
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Maastricht
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Poland
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Bialystok
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Bydgoszcz
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Katowice
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Krakow
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Lodz
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Lublin
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovakia
State/province [107] 0 0
Bratislava
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Slovakia
State/province [108] 0 0
Nitra
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Slovakia
State/province [109] 0 0
Presov
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Spain
State/province [110] 0 0
Madrid
Country [111] 0 0
Spain
State/province [111] 0 0
Pontevedra
Country [112] 0 0
Sweden
State/province [112] 0 0
Stockholm
Country [113] 0 0
Turkey
State/province [113] 0 0
Ankara
Country [114] 0 0
Turkey
State/province [114] 0 0
Istanbul
Country [115] 0 0
Ukraine
State/province [115] 0 0
Chernivtsi
Country [116] 0 0
Ukraine
State/province [116] 0 0
Dnipro
Country [117] 0 0
Ukraine
State/province [117] 0 0
Ivano-Frankivsk
Country [118] 0 0
Ukraine
State/province [118] 0 0
Kharkiv
Country [119] 0 0
Ukraine
State/province [119] 0 0
Kherson
Country [120] 0 0
Ukraine
State/province [120] 0 0
Kyiv
Country [121] 0 0
Ukraine
State/province [121] 0 0
Odesa
Country [122] 0 0
Ukraine
State/province [122] 0 0
Uzhgorod
Country [123] 0 0
Ukraine
State/province [123] 0 0
Vinnytsia
Country [124] 0 0
Ukraine
State/province [124] 0 0
Zaporizhzhia
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Devon
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Greater London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02611830