Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03221036 | Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis | PHASE3 | ACTIVE NOT_RECRUITING | 392 | — | — | Aug 3, 2017 | Jan 30, 2028 | May 22, 2026 | 36 | China |
Clinical response is defined as ≥3 points reduction in complete Mayo clinical score and ≥30% decrease from baseline score accompanied with ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding subscore ≤1. Mayo clinical score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.
Clinical remission is defined as complete Mayo clinic score ≤2 with no subscore \>1. Mayo clinic score is used to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo clinic score ranges from 0 to 12, with higher scores indicating more severe disease.
| Arm | Type | Description |
|---|---|---|
| Induction Phase: Vedolizumab 300 mg | EXPERIMENTAL | Vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, and 6 during induction phase. |
| Induction Phase: Placebo | PLACEBO_COMPARATOR | Matching placebo IV infusion at Weeks 0, 2, and 6 during induction phase. |
| Maintenance Phase: Vedolizumab 300 mg | EXPERIMENTAL | Participants who received vedolizumab IV 300 mg in induction phase and achieved clinical response at Week 10 will be randomized to receive vedolizumab 300 mg IV infusion at Weeks 14, 22, 30, 38, 46 and 54. Participants who did not achieve clinical response at Week 10 will receive vedolizumab 300 mg IV infusion every 4 weeks from Week 14 up to Week 58. |
| Maintenance Phase: Placebo | PLACEBO_COMPARATOR | Participants who received vedolizumab IV 300 mg in induction phase and achieved clinical response at Week 10 will be randomized to receive placebo, IV infusion at Weeks 14, 22, 30, 38, 46 and 54. Participants who received matching placebo in the induction phase and achieved clinical response at Week 10 will continue to receive placebo at Week 14, 22, 30, 38, 46, and 54. |
| Name | Type | Description |
|---|---|---|
| Vedolizumab IV | DRUG | Vedolizumab IV infusion |
| Placebo | DRUG | Matching-placebo IV infusion |
Inclusion Criteria: 1. Has a diagnosis of ulcerative colitis (UC) established at least 3 months prior to Screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of UC established at least 6 months before randomization for which a histopathology report is not ava...