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Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease

This study is currently recruiting participants.
Verified September 2017 by Takeda
Sponsor:
ClinicalTrials.gov Identifier:
NCT02611817
First Posted: November 23, 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 assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active Crohn's disease (CD) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Condition Intervention Phase
Crohn Disease Drug: Vedolizumab SC 108 Drug: Placebo SC Drug: Vedolizumab IV 300 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants Achieving Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤150 at Week 52.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Enhanced Clinical Response at Week 52 [ Time Frame: Baseline and Week 52 ]
    Enhanced clinical response is defined as a decrease from Baseline of ≥100 points in the Crohn's Disease Activity Index (CDAI) score at Week 52.

  • Percentage of Participants Achieving Corticosteroid-free Remission [ Time Frame: Baseline and Week 52 ]
    Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤150 at Week 52.


Estimated Enrollment: 824
Actual Study Start Date: January 4, 2016
Estimated Study Completion Date: September 3, 2020
Estimated Primary Completion Date: March 3, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab SC 108 mg Maintenance Arm

Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15)

Double-blind Maintenance: vedolizumab SC 108 mg injection Q2W starting at Week 6 up to Week 50

Drug: Vedolizumab SC 108 Drug: Vedolizumab IV 300 mg
Placebo Comparator: Placebo Maintenance Arm

Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15)

Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50

Drug: Placebo SC Drug: Vedolizumab IV 300 mg

Detailed Description:

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to treat people who have moderate to severely active Crohn's disease (CD). This study will look at clinical remission in participants with CD who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy.

The study will enroll approximately 824 patients. Participants will enter a 6 week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via infusion at Days 1 and 15, and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the two treatment groups:

  • Vedolizumab SC 108 mg Q2W
  • Placebo SC Q2W

Participants who do not achieve a clinical response will not be randomized into the Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at Week 6.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Crohn's disease (CD) established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
  2. Moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 450 within 7 days prior to the first dose of study drug and 1 of the following:

    • C-reactive protein (CRP) level >2.87 mg/L during the Screening Period OR
    • Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months prior to Screening OR
    • Fecal calprotectin >250 mcg/g stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient), within 4 months prior to Screening.
  3. CD involvement of the ileum and/or colon, at a minimum.
  4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists

Exclusion Criteria:

  1. Evidence of abdominal abscess Extensive colonic resection, subtotal or total colectomy.
  2. History of >3 small bowel resections or diagnosis of short bowel syndrome.
  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 CD required at any time during the study.
  8. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
  9. Suspected or confirmed diagnosis of ulcerative colitis, 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 (HCV) infection, TB (active or latent), or 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, or neurodegenerative disease.
  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): NCT02611817


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

  Show 258 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02611817     History of Changes
Other Study ID Numbers: MLN0002SC-3031
U1111-1168-0845 ( Registry Identifier: WHO )
2015-000481-58 ( EudraCT Number )
NL55774.056.16 ( Registry Identifier: CCMO )
16/LO/0090 ( Registry Identifier: NRES )
MLN0002SC-3031CTID ( Registry Identifier: Israel )
163300410A0045 ( Registry Identifier: NREC )
189748 ( Registry Identifier: HC-CTD )
First Submitted: November 19, 2015
First Posted: November 23, 2015
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vedolizumab
Gastrointestinal Agents


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