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NCT02038920

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

Completed Phase 3 Results posted Last updated 9 December 2019
What this trial tests

Phase 3 trial testing Vedolizumab in Crohn's Disease in 157 participants. Completed in 21 May 2019.

Timeline
28 January 2014
Primary endpoint
25 January 2019
21 May 2019

Quick facts

Lead sponsorTakeda
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment157
Start date28 January 2014
Primary completion25 January 2019
Estimated completion21 May 2019
Sites56 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Takeda — full company profile →

Who can join

Adults 15 to 80, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response Primary · Week 10

A response to therapy is considered 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. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg26.617.268 – 37.720
Induction Phase: Placebo16.79.184 – 26.813
Maintenance Phase: Percentage of Participants With Clinical Remission Primary · Week 60

Clinical remission is defined as the CDAI score ≤150. 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.

GroupValue95% CI
Maintenance Phase: Vedolizumab 300 mg41.715.165 – 72.333
Maintenance Phase: Placebo16.72.086 – 48.414
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) Primary · From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

An Adverse event (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 TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg49
Induction Phase: Placebo42
Maintenance Phase: Vedolizumab 300 mg9
Maintenance Phase: Placebo10
Maintenance Phase: Placebo Continuation12
Open-Label: Vedolizumab 300 mg130
Number of Participants With TEAE Related to Body Weight (Weight Decreased) Primary · From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Reported events on this outcome measure were "Weight Decreased".

GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg2
Number of Participants With TEAE Related to Vital Signs Primary · From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".

Pyrexia
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg3
Induction Phase: Placebo1
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo1
Maintenance Phase: Placebo Continuation1
Open-Label: Vedolizumab 300 mg19
Body Temperature Increased
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg1
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg0
Hypertension
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg1
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Orthostatic Hypotension
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] Primary · From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Reported events on this outcome measure were "Bundle Branch Block Right".

GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Primary · From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

The laboratory values outside the range (Hemoglobin \<=7 g/dL, Lymphocytes \<500 /microL, White Blood Cell (WBC) \<2000 /microL, Platelets \<7.5 10\^4/microL, Neutrophils \<1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) \>3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; 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.

Hemoglobin (g/dL) <=7
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo1
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg4
Lymphocytes (/uL) <500
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg7
Induction Phase: Placebo6
Maintenance Phase: Vedolizumab 300 mg1
Maintenance Phase: Placebo2
Maintenance Phase: Placebo Continuation1
Open-Label: Vedolizumab 300 mg18
WBC (/uL) <2000
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Platelets (10^4/uL) <7.5
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Neutrophils (/uL) <1000
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
ALT (GPT) (U/L) >3.0 x ULN
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg1
Induction Phase: Placebo1
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
AST (GOT) (U/L) >3.0 x ULN
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg1
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg1
Total Bilirubin (mg/dL) >2.0 x ULN
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0
Induction Phase: Placebo0
Maintenance Phase: Vedolizumab 300 mg0
Maintenance Phase: Placebo0
Maintenance Phase: Placebo Continuation0
Open-Label: Vedolizumab 300 mg4
Induction Phase: Percentage of Participants With Clinical Remission Secondary · Week 10

Clinical remission is defined as the CDAI score ≤150. 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.

GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg17.710.041 – 27.942
Induction Phase: Placebo10.34.533 – 19.213
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values Secondary · Baseline to Week 10
Change from Baseline at Week 2
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg0.022± 2.1421
Induction Phase: Placebo-0.125± 2.8417
Change from Baseline at Week 6
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg-0.089± 2.0266
Induction Phase: Placebo0.130± 2.1674
Change from Baseline at Week 10
GroupValue95% CI
Induction Phase: Vedolizumab, 300 mg-0.164± 2.2729
Induction Phase: Placebo0.077± 2.8690
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response Secondary · Week 60

A response to therapy is considered 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. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

GroupValue95% CI
Maintenance Phase: Vedolizumab 300 mg58.327.667 – 84.835
Maintenance Phase: Placebo8.30.211 – 38.480
Maintenance Phase: Percentage of Participants With Durable Clinical Remission Secondary · From Week 14 and Week 60

Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

GroupValue95% CI
Maintenance Phase: Vedolizumab 300 mg33.39.925 – 65.112
Maintenance Phase: Placebo25.05.486 – 57.186
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission Secondary · Week 60

Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

GroupValue95% CI
Maintenance Phase: Vedolizumab 300 mg40.05.274 – 85.337
Maintenance Phase: Placebo0.00.000 – 70.760

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Induction Phase: Vedolizumab, 300 mg
Serious: 8/79 (10%)
Deaths: 0/79
Induction Phase: Placebo
Serious: 10/78 (13%)
Deaths: 0/78
Maintenance Phase: Vedolizumab 300 mg
Serious: 2/12 (17%)
Deaths: 0/12
Maintenance Phase: Placebo
Serious: 4/12 (33%)
Deaths: 0/12
Maintenance Phase: Placebo Continuation
Serious: 2/17 (12%)
Deaths: 0/17
Open-Label: Vedolizumab 300 mg
Serious: 70/134 (52%)
Deaths: 0/134

Serious adverse events (53 terms)

ReactionSystemInduction Phase: Vedolizum…Induction Phase: PlaceboMaintenance Phase: Vedoliz…Maintenance Phase: PlaceboMaintenance Phase: Placebo…Open-Label: Vedolizumab 30…
Crohn's diseaseGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
Anal abscessInfections and infestations
IleusGastrointestinal disorders
Intestinal stenosisGastrointestinal disorders
Anal fistulaGastrointestinal disorders
Abdominal abscessInfections and infestations
Enteritis infectiousInfections and infestations
AscitesGastrointestinal disorders
SubileusGastrointestinal disorders
Hepatic function abnormalHepatobiliary disorders
Anaphylactoid reactionImmune system disorders
Gastroenteritis viralInfections and infestations
DehydrationMetabolism and nutrition disorders
Thyroid adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal adhesionsGastrointestinal disorders
CellulitisInfections and infestations
Erythema nodosumSkin and subcutaneous tissue disorders
Abdominal painGastrointestinal disorders
Enterovesical fistulaGastrointestinal disorders
Gastrointestinal haemorrhageGastrointestinal disorders
Ileal stenosisGastrointestinal disorders
Intestinal perforationGastrointestinal disorders
Large intestinal stenosisGastrointestinal disorders
Large intestine perforationGastrointestinal disorders
Other adverse events (48 terms — click to expand)

ReactionSystemInduction Phase: Vedolizum…Induction Phase: PlaceboMaintenance Phase: Vedoliz…Maintenance Phase: PlaceboMaintenance Phase: Placebo…Open-Label: Vedolizumab 30…
NasopharyngitisInfections and infestations
Crohn's diseaseGastrointestinal disorders
PyrexiaGeneral disorders
InfluenzaInfections and infestations
Dental cariesGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
Hepatic function abnormalHepatobiliary disorders
HeadacheNervous system disorders
Abdominal pain upperGastrointestinal disorders
InsomniaPsychiatric disorders
GastroenteritisInfections and infestations
Back painMusculoskeletal and connective tissue disorders
PharyngitisInfections and infestations
Enteritis infectiousInfections and infestations
HypoaesthesiaNervous system disorders
ConjunctivitisInfections and infestations
Iron deficiency anaemiaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
StomatitisGastrointestinal disorders
Chest painGeneral disorders
SwellingGeneral disorders
Allergy to metalsImmune system disorders
Seasonal allergyImmune system disorders
Anal abscessInfections and infestations
Dermatophytosis of nailInfections and infestations
PharyngotonsillitisInfections and infestations
RhinitisInfections and infestations
TonsillitisInfections and infestations
Bone contusionInjury, poisoning and procedural complications
Heat illnessInjury, poisoning and procedural complications
Blood urine presentInvestigations
Glucose urine presentInvestigations
Ocular neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervicobrachial syndromeNervous system disorders

Most-reported serious reactions: Crohn's disease, Intestinal obstruction, Anal abscess, Ileus, Intestinal stenosis, Anal fistula, Abdominal abscess, Enteritis infectious.

Data from ClinicalTrials.gov NCT02038920 adverse events section.

Sponsor's own description

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.
    Lu Q, Yang MF, Liang YJ, Xu J, et al · · 2022 · cited 152× · PMID 35310454 · DOI 10.2147/jir.s353038
  2. Vedolizumab: an α4β7 integrin antagonist for ulcerative colitis and Crohn's disease.
    Cherry LN, Yunker NS, Lambert ER, Vaughan D, et al · · 2015 · cited 43× · PMID 26336591 · DOI 10.1177/2040622315586970
  3. Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.
    Watanabe K, Motoya S, Ogata H, Kanai T, et al · · 2020 · cited 39× · PMID 31836930 · DOI 10.1007/s00535-019-01647-w
  4. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease.
    Okamoto H, Dirks NL, Rosario M, Hori T, et al · · 2021 · cited 23× · PMID 32635680 · DOI 10.5217/ir.2019.09167
  5. Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis.
    Solitano V, Hogan M, Singh S, Danese S, et al · · 2025 · cited 11× · PMID 39414161 · DOI 10.1053/j.gastro.2024.10.009
  6. Designing biologic selectivity for inflammatory bowel disease--role of vedolizumab.
    Krupka N, Baumgart DC. · · 2015 · cited 11× · PMID 25552903 · DOI 10.2147/dddt.s50348
  7. Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis.
    Peyrin-Biroulet L, Bossuyt P, Bettenworth D, Loftus EV, et al · · 2024 · cited 10× · PMID 38499736 · DOI 10.1007/s10620-023-08252-1
  8. Defining the Failure of Medical Therapy for Inflammatory Bowel Disease in the Era of Advanced Therapies: A Systematic Review.
    State M, Negreanu L. · · 2023 · cited 10× · PMID 36831079 · DOI 10.3390/biomedicines11020544

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02038920.

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