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 ResponsePrimary· 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.
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
26.6
17.268 – 37.720
Induction Phase: Placebo
16.7
9.184 – 26.813
Maintenance Phase: Percentage of Participants With Clinical RemissionPrimary· 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.
Group
Value
95% CI
Maintenance Phase: Vedolizumab 300 mg
41.7
15.165 – 72.333
Maintenance Phase: Placebo
16.7
2.086 – 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.
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
49
Induction Phase: Placebo
42
Maintenance Phase: Vedolizumab 300 mg
9
Maintenance Phase: Placebo
10
Maintenance Phase: Placebo Continuation
12
Open-Label: Vedolizumab 300 mg
130
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".
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
2
Number of Participants With TEAE Related to Vital SignsPrimary· 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
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
3
Induction Phase: Placebo
1
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
1
Maintenance Phase: Placebo Continuation
1
Open-Label: Vedolizumab 300 mg
19
Body Temperature Increased
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
1
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
0
Hypertension
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
1
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
Orthostatic Hypotension
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
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".
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
Number of Participants With Markedly Abnormal Values of Laboratory Parameters ValuesPrimary· 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
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
1
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
4
Lymphocytes (/uL) <500
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
7
Induction Phase: Placebo
6
Maintenance Phase: Vedolizumab 300 mg
1
Maintenance Phase: Placebo
2
Maintenance Phase: Placebo Continuation
1
Open-Label: Vedolizumab 300 mg
18
WBC (/uL) <2000
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
Platelets (10^4/uL) <7.5
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
Neutrophils (/uL) <1000
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
ALT (GPT) (U/L) >3.0 x ULN
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
1
Induction Phase: Placebo
1
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
AST (GOT) (U/L) >3.0 x ULN
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
1
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
1
Total Bilirubin (mg/dL) >2.0 x ULN
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0
Induction Phase: Placebo
0
Maintenance Phase: Vedolizumab 300 mg
0
Maintenance Phase: Placebo
0
Maintenance Phase: Placebo Continuation
0
Open-Label: Vedolizumab 300 mg
4
Induction Phase: Percentage of Participants With Clinical RemissionSecondary· 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.
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
17.7
10.041 – 27.942
Induction Phase: Placebo
10.3
4.533 – 19.213
Induction Phase: Change From Baseline in C-reactive Protein (CRP) ValuesSecondary· Baseline to Week 10
Change from Baseline at Week 2
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
0.022
± 2.1421
Induction Phase: Placebo
-0.125
± 2.8417
Change from Baseline at Week 6
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
-0.089
± 2.0266
Induction Phase: Placebo
0.130
± 2.1674
Change from Baseline at Week 10
Group
Value
95% CI
Induction Phase: Vedolizumab, 300 mg
-0.164
± 2.2729
Induction Phase: Placebo
0.077
± 2.8690
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 ResponseSecondary· 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.
Group
Value
95% CI
Maintenance Phase: Vedolizumab 300 mg
58.3
27.667 – 84.835
Maintenance Phase: Placebo
8.3
0.211 – 38.480
Maintenance Phase: Percentage of Participants With Durable Clinical RemissionSecondary· 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.
Group
Value
95% CI
Maintenance Phase: Vedolizumab 300 mg
33.3
9.925 – 65.112
Maintenance Phase: Placebo
25.0
5.486 – 57.186
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical RemissionSecondary· 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.
Group
Value
95% CI
Maintenance Phase: Vedolizumab 300 mg
40.0
5.274 – 85.337
Maintenance Phase: Placebo
0.0
0.000 – 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)
Reaction
System
Induction Phase: Vedolizum…
Induction Phase: Placebo
Maintenance Phase: Vedoliz…
Maintenance Phase: Placebo
Maintenance Phase: Placebo…
Open-Label: Vedolizumab 30…
Crohn's disease
Gastrointestinal disorders
—
—
—
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
Anal abscess
Infections and infestations
—
—
—
—
—
—
Ileus
Gastrointestinal disorders
—
—
—
—
—
—
Intestinal stenosis
Gastrointestinal disorders
—
—
—
—
—
—
Anal fistula
Gastrointestinal disorders
—
—
—
—
—
—
Abdominal abscess
Infections and infestations
—
—
—
—
—
—
Enteritis infectious
Infections and infestations
—
—
—
—
—
—
Ascites
Gastrointestinal disorders
—
—
—
—
—
—
Subileus
Gastrointestinal disorders
—
—
—
—
—
—
Hepatic function abnormal
Hepatobiliary disorders
—
—
—
—
—
—
Anaphylactoid reaction
Immune system disorders
—
—
—
—
—
—
Gastroenteritis viral
Infections and infestations
—
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
—
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Abdominal adhesions
Gastrointestinal disorders
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
Erythema nodosum
Skin and subcutaneous tissue disorders
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
Enterovesical fistula
Gastrointestinal disorders
—
—
—
—
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
Ileal stenosis
Gastrointestinal disorders
—
—
—
—
—
—
Intestinal perforation
Gastrointestinal disorders
—
—
—
—
—
—
Large intestinal stenosis
Gastrointestinal disorders
—
—
—
—
—
—
Large intestine perforation
Gastrointestinal disorders
—
—
—
—
—
—
Other adverse events (48 terms — click to expand)
Reaction
System
Induction Phase: Vedolizum…
Induction Phase: Placebo
Maintenance Phase: Vedoliz…
Maintenance Phase: Placebo
Maintenance Phase: Placebo…
Open-Label: Vedolizumab 30…
Nasopharyngitis
Infections and infestations
—
—
—
—
—
—
Crohn's disease
Gastrointestinal disorders
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
Influenza
Infections and infestations
—
—
—
—
—
—
Dental caries
Gastrointestinal disorders
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
—
—
—
Hepatic function abnormal
Hepatobiliary disorders
—
—
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
—
—
—
—
Insomnia
Psychiatric disorders
—
—
—
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Pharyngitis
Infections and infestations
—
—
—
—
—
—
Enteritis infectious
Infections and infestations
—
—
—
—
—
—
Hypoaesthesia
Nervous system disorders
—
—
—
—
—
—
Conjunctivitis
Infections and infestations
—
—
—
—
—
—
Iron deficiency anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
—
Gastrooesophageal reflux disease
Gastrointestinal disorders
—
—
—
—
—
—
Stomatitis
Gastrointestinal disorders
—
—
—
—
—
—
Chest pain
General disorders
—
—
—
—
—
—
Swelling
General disorders
—
—
—
—
—
—
Allergy to metals
Immune system disorders
—
—
—
—
—
—
Seasonal allergy
Immune system disorders
—
—
—
—
—
—
Anal abscess
Infections and infestations
—
—
—
—
—
—
Dermatophytosis of nail
Infections and infestations
—
—
—
—
—
—
Pharyngotonsillitis
Infections and infestations
—
—
—
—
—
—
Rhinitis
Infections and infestations
—
—
—
—
—
—
Tonsillitis
Infections and infestations
—
—
—
—
—
—
Bone contusion
Injury, poisoning and procedural complications
—
—
—
—
—
—
Heat illness
Injury, poisoning and procedural complications
—
—
—
—
—
—
Blood urine present
Investigations
—
—
—
—
—
—
Glucose urine present
Investigations
—
—
—
—
—
—
Ocular neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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):
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di
· Phase 2
· recruiting
NCT06227910 — A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
· Phase 3
· recruiting
NCT06443502 — A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pou
· Phase 3
· recruiting
NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
· Phase 3
· terminated
Other recruiting trials for Crohn's Disease
Currently open trials in the same condition.
NCT07273188 — 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
· EARLY_PHASE1
· recruiting
NCT07184944 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti
· Phase 3
· recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea
· recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD
· Phase 3
· recruiting
NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ
· Phase 3
· recruiting
Other Takeda trials
Trials by the same sponsor.
NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras
· not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
· Phase 2
· not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema
· NA
· not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
· not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 9 December 2019
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.