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Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

This study is not yet open for participant recruitment.
Verified January 2014 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02039505
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002 (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or severely active ulcerative colitis.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Examine the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Patients With Moderately or Severely Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Induction phase: Clinical response at Week 10 [ Time Frame: At week 10 ] [ Designated as safety issue: No ]
    Percentage of patients randomized to the induction phase showing a clinical response (complete Mayo score decreased ≥3 points and ≥ 30 percent from baseline, and the rectal bleeding subscore decreased ≥1 point from baseline or is ≤1) at Week 10 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Maintenance Phase: Clinical remission at Week 60 [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase showing clinical remission (the complete Mayo score is ≤2 and all subscores are ≤1) at Week 60 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Advrse Events [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Tabulation of incidence of adverse events Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug

  • Body Weight [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Summary statistics for body weight at each evaluation time point.

  • Vital signs [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Summary statistics for vital signs at each evaluation time point.

  • Electrocardiogram (ECG) [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Summary statistics for Electrocardiogram (ECG) measurements at each evaluation time point.

  • Clinical laboratory test (bloodbiochemistry, hematology, and urinalysis) [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Summary statistics for measurements of clinical laboratory test at each evaluation time point.


Secondary Outcome Measures:
  • Induction Phase: Clinical remission at Week 10 [ Time Frame: at Week 10 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the induction phase showing clinical remission (the complete Mayo score is ≤ 2 and all subscores are ≤ 1) at Week 10 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Induction Phase: Mucosal healing at Week 10 [ Time Frame: At Week 10 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the induction phase showing mucosal healing (the endoscopic subscore of the complete Mayo score is ≤ 1) at Week 10 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Maintenance Phase: Durable clinical response [ Time Frame: At Week 10 and Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase showing clinical response (complete Mayo score decreased ≥ 3 points and ≥30 percent from baseline, and the rectal bleeding subscore decreased ≥ 1 point from baseline or is ≤ 1) at both Week 10 and 60 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Maintenance Phase: Mucosal healing at Week 60 [ Time Frame: At week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase showing mucosal healing (the endoscopic subscore of the complete Mayo score is ≤ 1) at Week 60 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Maintenance Phase: Durable clinical remission [ Time Frame: At Week 10 and Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase showing clinical remission (the complete Mayo score is ≤ 2 and all subscores are ≤1) at both Week 10 and 60 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Maintenance Phase: Corticosteroid-free clinical remission at Week 60 [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase who were using corticosteroids at initiation of study drug treatment, but are not using corticosteroids and show clinical remission (the complete Mayo score is ≤2 and all subscores are ≤1) at Week 60 The Mayo Score is widely used in clinical trials to assess Ulcerative Colitis disease activity. It is a combination of two patient-reported and two physician-determined components. The Mayo score ranges from 0−12, with higher scores indicating more severe disease.

  • Serum Vedolizumab concentration [ Time Frame: From Week 2 to Week 60 ] [ Designated as safety issue: No ]
    Summary statistics for serum Vedolizumab concentration at each evaluation time point

  • Human anti-human antibody (HAHA) [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    Tabulation of incidence of Human anti-human antibody (HAHA)

  • Neutralizing antibody [ Time Frame: From baseline to 16 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    Tabulation of incidence of neutralizing antibody


Estimated Enrollment: 278
Study Start Date: January 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab 300mg
Intravenous Vedolizumab (300 mg) administered at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Drug: Vedolizumab
Vedolizumab intravenous injection
Other Name: MLN0002
Placebo Comparator: Placebo
Vedolizumab Placebo. Intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter
Drug: Vedolizumab placebo
Vedolizumab placebo

Detailed Description:

This study is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous Vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese patients with moderately or severely active ulcerative colitis/

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 15 to 80 years (inclusive) at the time of consent
  2. Patients with a diagnosis of total or left-sided colitis established based on the Revised Diagnostic Criteria for Ulcerative Colitis issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 6 months before the start of administration of study drug.
  3. Patients with moderately or severely active ulcerative colitis as determined by baseline complete Mayo score of 6 to 12 (inclusive) with an endoscopic subscore of ≥2
  4. In case of the patients who meet any of the following criteria; patients with ≥8-year history of total or left-sided colitis, patients aged ≥ 50 years, or patients with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (Or the results from total colonoscopy performed within 1 year before giving consent are available).
  5. Patients meeting the criteria for treatment failure below with at least one of the following agents received within the previous 5 year period before giving consent.

Corticosteroids

  • Resistance
  • Dependence
  • Intolerance Immunomodulators (azathioprine or 6-mercaptopurine)
  • Refractory
  • Intolerance Anti-TNFα antibodies
  • Inadequate response
  • Loss of response
  • Intolerance

Exclusion Criteria:

  • 1. Patients whose partial Mayo score decrease by 3 points or more between screening and the start of study drug administration 2. Patients with an evidence of or suspected abdominal abscess or toxic megacolon 3. Patients with a history of subtotal or total colectomy 4. Patients with ileostomy, colostomy,or fistula, or severe intestinal stenosis 5. Patients who started 5-aminosalicylic acid oral drug or probiotics treatment or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration 6. Patients who have received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of ulcerative colitis (e.g., Daikenchuto) within 13 days before initiation of the study drug administration 7. Patients who have received an antidiarrheal drug for at 4 or more days consecutively within 13 days before initiation of the study drug administration or an antidiarrheal drug within 7 days before initiation of the study drug administration 8. Patients who have received azathioprine or 6-mercaptopurine within 27 days before initiation of the study drug administration. However, this shall not apply to patients who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration 9. Patients who have received cyclosporin, tacrolimus, methotrexate, or tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration 10. Patients who have received adalimumab within 27 days before initiation of the study drug administration or any biological drugs other than adalimumab within 55 days before initiation of the study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed 11. Patients who have received any live vaccinations within 27 days before initiation of study drug administration 12. Patients who have undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study 13. Patients who have received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration 14. Patients with an evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration 15. Patients with a history or a complication of colonic mucosal dysplasia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039505

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 (USA & EU) medicalinformation@tpna.com

Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02039505     History of Changes
Other Study ID Numbers: MLN0002/CCT-101, U1111-1151-6762
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014