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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 16 July 2019
Main ID:  JPRN-JapicCTI-142402
Date of registration: 27/12/2013
Prospective Registration: Yes
Primary sponsor: Takeda Pharmaceutical Company Limited
Public title: Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease
Scientific title: Phase III, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe Crohn's disease
Date of first enrolment: 28/1/2014
Target sample size: 157
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-142402
Study type:  INTERVENTIONAL
Study design:  Multicenter, randomized, double-blinded, parallel-group study  
Phase:  3
Countries of recruitment
Japan
Contacts
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Participants aged 15 to 80 years (inclusive) at the time of consent
2. Participants 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. Participants 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
- Participants 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
- Participants 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 participants who meet any of the following criteria; participants with >= 8-year history of extensive or limited colitis, participants aged >= 50 years, or participants 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. Participants 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.
a. Corticosteroids
- Resistance
- Dependence
- Intolerance
b. Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
- Refractory
- Intolerance
c. Anti-TNF alpha antibodies
- Inadequate response
- Loss of response
- Intolerance

Exclusion criteria: 1. Participants with an evidence of or suspected abdominal abscess
2. Participants with a history of subtotal or total colectomy
3. Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome
4. Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis
5. Participants 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. Participants 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. Participants who have received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants 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. Participants 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. Participants 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 the study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed
10. Participants who have received any live vaccinations within 27 days before initiation of study drug administration
11. Participants 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. Participants who have received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration
13. Participants who have received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration. Or participants who are fasted.
14. Participants 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.
Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration and whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration
15. Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration
16. Participants with a history or an complication of dysplasia of the small or large intestine


Age minimum: 15
Age maximum: 80
Gender: BOTH
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (300 mg) administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Vedolizumab Placebo administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Primary Outcome(s)
efficacy
Induction phase: Crohn's Disease Activity Index (CDAI)-100 response at Week 10
Time Frame: At Week 10
Reported data will be percentage of participants randomized to the induction phase with a decrease from baseline of at least 100 points in the CDAI score 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.
efficacy
Maintenance Phase: Clinical remission at Week 60
Time Frame: At Week 60
Reported data will be percentage of participants randomized to the maintenance phase with clinical remission (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.
safety
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From baseline to 16 weeks after the last dose of study drug
Tabulation of incidence of adverse events. An AE is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
safety
Number of Participants with TEAE Related to Body Weight
Time Frame: From baseline to 16 weeks after the last dose of study drug
safety
Number of Participants with TEAE Related to Vital Signs
Time Frame: From baseline to 16 weeks after the last dose of study drug
Vital signs include body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
safety
Number of Participants with TEAE Related to Electrocardiogram (ECG)
Time Frame: From baseline to 16 weeks after the last dose of study drug
safety
Number of Participants with Markedly Abnormal Values of Laboratory Parameters Values
Time Frame: From baseline to 16 weeks after the last dose of study drug
The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, WBC <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, ALT (GPT) >3.0 U/L x upper limit of normal (ULN), AST (GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.
Secondary Outcome(s)
efficacy
Induction phase: Clinical remission at Week 10
Time Frame: At Week 10
Reported data will be percentage of participants randomized to the induction phase with clinical remission (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.
efficacy
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
efficacy
Maintenance Phase: CDAI-100 response at Week 60
Time Frame: At Week 60
Reported data will be percentage of participants randomized to the maintenance phase with a decrease from baseline of at least 100 points in the 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.
efficacy
Maintenance Phase: Durable clinical remission
Time Frame: From Week 14 to Week 60
Reported data will be percentage of participants randomized to the maintenance phase with clinical remission (CDAI score =< 150) 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.
efficacy
Maintenance Phase: Corticosteroid-free clinical remission at Week 60
Time Frame: At Week 60
Reported data will be percentage of participants randomized to the maintenance phase who are not using the corticosteroids used at initiation of study drug administration and who show clinical remission (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.
pharmacokinetics
Serum Vedolizumab concentration
Time Frame: From Week 2 to Week 60
Summary statistics for serum Vedolizumab concentration at each evaluation time point
other
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)
other
Neutralizing antibody
Time Frame: From baseline to 16 weeks after the last dose of study drug
Tabulation of incidence of neutralizing antibody
Secondary ID(s)
NCT02038920
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
-
Tokyo Yamate Medical Center IRB
-
-
Results
Results available:
Date Posted:
Date Completed: 21/05/2019
URL:
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