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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02038920
Date of registration: 15/01/2014
Prospective Registration: Yes
Primary sponsor: Takeda
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: January 28, 2014
Target sample size: 157
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02038920
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Study Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. In the opinion of the investigator, participants were capable of understanding and
complying with protocol requirements

2. Participants or, when applicable, participants legally acceptable representative sign
and date the informed consent form prior to initiation of any study procedures

3. Participants aged 15 to 80 years (inclusive) at the time of consent

4. A nonsterilized male participant who has a female partner of child-bearing potential
has to agree to use adequate contraception during the period from the signing of
informed consent to 6 months after the last dose of the study drug

5. A female participant of child-bearing potential (i.e., nonsterilized or whose last
regular menses was within previous 2 years) who has a nonsterilized male partner has
to agree to use adequate contraception during the period from the signing of informed
consent to 6 months after the last dose of the study drug

6. Participants with a diagnosis of small-intestinal, large-intestinal, or
small-/large-intestinal Crohn's disease (CD) 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

7. Participants with baseline 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

8. 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)

9. Participants meeting the criteria for treatment failure below with at least one of the
following agents received within previous 5 year period before giving consent

1. Corticosteroids

- Resistance

- Dependence

- Intolerance

2. Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)

- Refractory

- Intolerance

3. Anti-tumor necrosis factor alpha (TNFa) 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 have a treatment history with natalizumab, efalizumab or rituximab

6. 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

7. Participants who had 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

8. Participants who had 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

9. Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs
for treatment of ulcerative colitis within 27 days before initiation of the study drug
administration

10. Participants who had 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

11. Participants who had received any live vaccinations within 27 days before initiation
of study drug administration

12. Participants who had undergone intestinal resection within 27 days before initiation
of study drug administration or those anticipated to require intestinal resection
during the study

13. Participants who had received leukocytapheresis or granulocyte apheresis within 27
days before initiation of the study drug administration

14. Participants who had received intravenous hyperalimentation or total enteral nutrition
within the 20 days before initiation of the study drug administration or participants
who are fasted

15. Participants who had 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 whom these dosage
was changed or the medications were discontinued within 20 days before initiation o



Age minimum: 15 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Vedolizumab
Drug: Vedolizumab placebo
Primary Outcome(s)
Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response [Time Frame: Week 10]
Maintenance Phase: Percentage of Participants With Clinical Remission [Time Frame: Week 60]
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) [Time Frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)]
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values [Time Frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)]
Number of Participants With TEAE Related to Body Weight (Weight Decreased) [Time Frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)]
Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] [Time Frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)]
Number of Participants With TEAE Related to Vital Signs [Time Frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)]
Secondary Outcome(s)
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values [Time Frame: Baseline to Week 10]
Induction Phase: Percentage of Participants With Clinical Remission [Time Frame: Week 10]
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission [Time Frame: Week 60]
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response [Time Frame: Week 60]
Maintenance Phase: Percentage of Participants With Durable Clinical Remission [Time Frame: From Week 14 and Week 60]
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase [Time Frame: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase]
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase [Time Frame: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase]
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort [Time Frame: Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort]
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase [Time Frame: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase]
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase [Time Frame: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase]
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort [Time Frame: Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort]
Serum Vedolizumab Concentration in Induction Phase [Time Frame: Weeks 2, 6, 10 and 14]
Serum Vedolizumab Concentration in Maintenance Phase [Time Frame: Weeks 2, 6, 10, 14, 22, 30 and 60]
Secondary ID(s)
JapicCTI-142402
MLN0002/CCT-001
U1111-1150-2688
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 09/12/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02038920
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