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Trial record 1 of 1 for:    NCT02038920
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Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038920
First Posted: January 17, 2014
Last Update Posted: November 7, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Tabulation of incidence of neutralizing antibody


Enrollment: 157
Actual Study Start Date: January 28, 2014
Estimated Study Completion Date: February 21, 2019
Estimated Primary Completion Date: February 21, 2019 (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

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:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT02038920


Locations
Japan
Nagoya-shi, Aichi, Japan
Toyota-shi, Aichi, Japan
Hirosaki-shi, Aomori, Japan
Kashiwa-shi, Chiba, Japan
Sakura-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Fukui-shi, Fukui, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka-shi, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Takasaki-shi, Gunma, Japan
Fukuyama-shi, Hiroshima, Japan
Hatsukaichi-shi, Hiroshima, Japan
Hiroshima-shi, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Tomakomai-shi, Hokkaido, Japan
Akashi-shi, Hyogo, Japan
Nishinomiya-shi, Hyogo, Japan
Kagoshima-shi, Kagoshima, Japan
Kamakura-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kochi-shi, Kochi, Japan
Kumamoto-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Sendai-shi, Miyagi, Japan
Nagasaki-shi, Nagasaki, Japan
Ohita-shi, Ohita, Japan
Okayama-shi, Okayama, Japan
Moriguchi-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Saga-shi, Saga, Japan
Tokorozawa-shi, Saitama, Japan
Hamamatsu-shi, Shizuoka, Japan
Shimotsuke-shi, Tochigi, Japan
Adachi-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Wakayama-shi, Wakayama, Japan
Shunan-shi, Yamaguchi, Japan
Kofu-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02038920     History of Changes
Other Study ID Numbers: MLN0002/CCT-001
U1111-1150-2688 ( Registry Identifier: UTN (WHO) )
First Submitted: January 15, 2014
First Posted: January 17, 2014
Last Update Posted: November 7, 2017
Last Verified: November 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