Adults 18 to 80, any sex, with Colitis, Ulcerative. 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 complete Mayo score ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
14.3
6.4 – 26.2
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
46.2
36.5 – 56.2
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
42.6
29.2 – 56.8
Percentage of Participants Achieving Mucosal Healing at Week 52Secondary· Week 52
Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
21.4
11.6 – 34.4
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
56.6
46.6 – 66.2
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
53.7
39.6 – 67.4
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52Secondary· Baseline, Weeks 6 and 52
Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
28.6
17.3 – 42.2
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
64.2
54.3 – 73.2
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
72.2
58.4 – 83.5
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52Secondary· Weeks 6 and 52
Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (\>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater dis
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
5.4
1.1 – 14.9
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
15.1
8.9 – 23.4
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
16.7
7.9 – 29.3
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 complete Mayo score of ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete
Group
Value
95% CI
Maintenance Phase: Induction IV + Placebo
8.3
1.0 – 27.0
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
28.9
16.4 – 44.3
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
28.6
11.3 – 52.2
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Vedolizumab IV 300 mg, Induction Phase Only
Serious: 17/167 (10%)
Deaths: 0/167
Maintenance Phase: Induction IV + Placebo
Serious: 6/56 (11%)
Deaths: 0/56
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Serious: 10/106 (9%)
Deaths: 0/106
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) 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):
NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
· recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea
· recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col
· Phase 3
· recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
· recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli
· 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/NCT02611830.