Adults 18 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.
Percentage of Participants Achieving Clinical Remission at Week 52Primary· Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (\<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
34.3
26.3 – 43.0
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
48.0
42.0 – 54.1
Percentage of Participants Achieving Enhanced Clinical Response at Week 52Secondary· Week 52
Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (\>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight).
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
44.8
36.2 – 53.6
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
52.0
45.9 – 58.0
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52Secondary· Week 52
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score \<=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicat
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
18.2
8.2 – 32.7
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
45.3
35.0 – 55.8
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52Secondary· Week 52
Clinical remission is defined as CDAI score \<=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
42.9
30.5 – 56.0
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
48.6
38.8 – 58.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Induction Phase Only: Vedolizumab 300 mg IV
Serious: 39/235 (17%)
Deaths: 0/235
Maintenance Phase: Induction IV + Placebo
Serious: 14/134 (10%)
Deaths: 0/134
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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
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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: 25 May 2022
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/NCT02611817.