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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06660693 | Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis | PHASE3 | RECRUITING | 134 | — | — | Apr 16, 2025 | Sep 1, 2027 | Jun 22, 2025 | 1 | Canada |
The primary objective of this study is to evaluate whether treatment success in ASUC patients in patients treated with strategy U is non-inferior to strategy C after 16 weeks of initiating therapeutic management.
| Arm | Type | Description |
|---|---|---|
| Upadacitinib (treatment arm) | ACTIVE_COMPARATOR | Participants will receive Upadacitinib 45mg daily, once a day, for at least five days. |
| Infliximab (standard care) | NO_INTERVENTION | Participants will receive standard care, which is Infliximab. |
| Name | Type | Description |
|---|---|---|
| Upadacitinib Oral Product | DRUG | Upadacitinib oral 45mg once daily. |
Inclusion Criteria: Adult (≥ 18 - 64 years) male or non-pregnant, non-lactating female patients with: * Confirmed diagnosis of UC, based on conventional clinical, endoscopic, and/or histologic criteria * Admitted to hospital with acute severe flare and refractory to three days of intravenous steroi...