We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02497469
Previous Study | Return to List | Next Study

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

This study is currently recruiting participants.
Verified September 2017 by Takeda
Sponsor:
ClinicalTrials.gov Identifier:
NCT02497469
First Posted: July 14, 2015
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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.

Condition Intervention Phase
Colitis, Ulcerative Drug: Vedolizumab Drug: Adalimumab placebo Drug: Adalimumab Drug: Vedolizumab placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 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. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consists of 4 subscores: stool frequency, rectal bleeding, findings of endoscopy, and physician global assessment, each ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).


Secondary Outcome Measures:
  • Percentage of Participants Achieving Mucosal Healing [ Time Frame: Week 52 ]
    Mucosal healing is defined as Mayo endoscopic subscore <=1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Findings of endoscopy is a subscale of Mayo score, which ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

  • Percentage of Participants Using Oral Corticosteroids at Baseline who Discontinue Corticosteroids and are in Clinical Remission [ Time Frame: Week 52 ]
    Corticosteroid-free remission: participants who discontinue corticosteroids and achieve clinical remission will be assessed in participants with baseline oral corticosteroid use. Clinical remission is defined as a complete Mayo score of <=2 points and no individual subscore >1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consists of 4 subscores: stool frequency, rectal bleeding, findings of endoscopy, and physician global assessment, each ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).


Estimated Enrollment: 658
Actual Study Start Date: July 15, 2015
Estimated Study Completion Date: October 18, 2018
Estimated Primary Completion Date: October 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab IV
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.
Drug: Vedolizumab
Vedolizumab infusion
Drug: Adalimumab placebo
Adalimumab placebo-matching injection
Active Comparator: Adalimumab SC
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.
Drug: Adalimumab
Adalimumab injection
Drug: Vedolizumab placebo
Vedolizumab placebo-matching infusion

Detailed Description:

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab 300 mg IV
  • Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497469


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 331 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02497469     History of Changes
Other Study ID Numbers: MLN0002-3026
U1111-1168-6713 ( Registry Identifier: WHO )
2015-000939-33 ( EudraCT Number )
NL54690.056.15 ( Registry Identifier: CCMO )
First Submitted: July 10, 2015
First Posted: July 14, 2015
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Vedolizumab
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents


To Top