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Trial record 4 of 11 for:    vedolizumab

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02038920
First received: January 15, 2014
Last updated: May 26, 2014
Last verified: May 2014
  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 Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Drug: Vedolizumab
Drug: Vedolizumab placebo
Phase 3

Study Type: Interventional
Study Design: 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 Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Induction phase: Crohn's Disease Activity Index (CDAI)-100 response at Week 10 [ Time Frame: At Week 10 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the induction phase with a decrease from baseline of at least 100 points in the Crohn's Disease Activity Index (CDAI) score at Week 10CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active 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 with clinical remission (Crohn's Disease Activity Index (CDAI) score ≤150) at Week 60 CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

  • Adverse 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 with clinical remission (Crohn's Disease Activity Index (CDAI) score ≤150) at Week 10 CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

  • Induction phase: Changes in C-reactive protein (CRP) values [ Time Frame: From baseline to Week 10 ] [ Designated as safety issue: No ]
    Summary statistics of C-reactive protein (CRP) values at each evaluation time point in the subpopulation of subjects randomized to the induction phase with a baseline CRP value exceeding 0.30 mg/dL

  • Maintenance Phase: Crohn's Disease Activity Index (CDAI)-100 response at Week 60 [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase with a decrease from baseline of at least 100 points in the Crohn's Disease Activity Index (CDAI) score at Week 60 CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

  • Maintenance Phase: Durable clinical remission [ Time Frame: From Week 14 to Week 60 ] [ Designated as safety issue: No ]
    Percentage of subjects randomized to the maintenance phase with clinical remission (Crohn's Disease Activity Index (CDAI) score ≤ 150) at at least 80 percent of the scheduled visits, including Week 60 CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active 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 are not using the corticosteroids used at initiation of study drug administration and who show clinical remission (Crohn's Disease Activity Index (CDAI) score ≤ 150) at Week 60 CDAI is scoring system for the Assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active 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: 110
Study Start Date: March 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 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 Crohn's disease.

  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 small-intestinal, large-intestinal,or small-/large-intestinal Crohn's disease established based on the Revised Diagnostic Criteria for Crohn's disease 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 3 months before the start of administration of study drug 3. Patients with baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450(inclusive) and meeting at least one of the followings:

    • C-reactive protein (CRP) at screening test is above 0.30 mg/dL
    • Patients with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs
    • Patients with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs 4. In case of the patients who meet any of the following criteria; patients with ≥ 8-year history of extensive or limited 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 previous 5 year period before giving consent Corticosteroids
    • Resistance
    • Dependence
    • Intolerance Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
    • Refractory
    • Intolerance Anti-TNFα antibodies
    • Inadequate response
    • Loss of response
    • Intolerance

Exclusion Criteria:

  • Patients with an evidence of or suspected abdominal abscess 2. Patients with a history of subtotal or total colectomy 3. Patients who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome 4. Patients with ileostomy,colostomy,or internal fistula, or severe intestinal stenosis 5. Patients who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, 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 Crohn's disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration 7. Patients who have received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of 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 8. Patients who have received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration 9. Patients who have received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration.Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed 10. Patients who have received any live vaccinations within 27 days before initiation of study drug administration 11. 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 12. Patients who have received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration 13. Patients who have received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration. Or patients who are fasted 14. Patients who have received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Patients receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration 15. Patients with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration 16. Patients with a history or an an complication of dysplasia of the small or large intestine
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038920

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

Locations
Japan
Not yet recruiting
Nagoya-shi, Aichi, Japan
Not yet recruiting
Toyota-shi, Aichi, Japan
Not yet recruiting
Hirosaki-shi, Aomori, Japan
Recruiting
Sakura-shi, Chiba, Japan
Not yet recruiting
Fukui-shi, Fukui, Japan
Not yet recruiting
Chikushino-shi, Fukuoka, Japan
Not yet recruiting
Fukuoka-shi, Fukuoka, Japan
Not yet recruiting
Kitakyushu-shi, Fukuoka, Japan
Not yet recruiting
Fukuyama-shi, Hiroshima, Japan
Not yet recruiting
Hatsukaichi-shi, Hiroshima, Japan
Not yet recruiting
Hiroshima-shi, Hiroshima, Japan
Not yet recruiting
Asahikawa-shi, Hokkaido, Japan
Recruiting
Sapporo-shi, Hokkaido, Japan
Not yet recruiting
Tomakomai-shi, Hokkaido, Japan
Not yet recruiting
Akashi-shi, Hyogo, Japan
Not yet recruiting
Nishinomiya-shi, Hyogo, Japan
Not yet recruiting
Kagoshima-shi, Kagoshima, Japan
Not yet recruiting
Kamakura-shi, Kanagawa, Japan
Not yet recruiting
Kawasaki-shi, Kanagawa, Japan
Not yet recruiting
Sagamihara-shi, Kanagawa, Japan
Not yet recruiting
Yokohama-shi, Kanagawa, Japan
Not yet recruiting
Kochi-shi, Kochi, Japan
Not yet recruiting
Kumamoto-shi, Kumamoto, Japan
Not yet recruiting
Kyoto-shi, Kyoto, Japan
Not yet recruiting
Sendai-shi, Miyagi, Japan
Not yet recruiting
Nagasaki-shi, Nagasaki, Japan
Not yet recruiting
Ohita-shi, Ohita, Japan
Not yet recruiting
Moriguchi-shi, Osaka, Japan
Recruiting
Osaka-shi, Osaka, Japan
Not yet recruiting
Suita-shi, Osaka, Japan
Not yet recruiting
Saga-shi, Saga, Japan
Not yet recruiting
Tokorozawa-shi, Saitama, Japan
Not yet recruiting
Hamamatsu-shi, Shizuoka, Japan
Not yet recruiting
Shimotsuke-shi, Tochigi, Japan
Not yet recruiting
Adachi-ku, Tokyo, Japan
Not yet recruiting
Bunkyo-ku, Tokyo, Japan
Not yet recruiting
Chiyoda-ku, Tokyo, Japan
Recruiting
Minato-ku, Tokyo, Japan
Not yet recruiting
Shinagawa-ku, Tokyo, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Not yet recruiting
Shunan-shi, Yamaguchi, Japan
Not yet recruiting
Kofu-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02038920     History of Changes
Other Study ID Numbers: MLN0002/CCT-001, U1111-1150-2688
Study First Received: January 15, 2014
Last Updated: May 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

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

ClinicalTrials.gov processed this record on November 20, 2014