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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03235752 | Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis | PHASE2 | COMPLETED | 91 | — | — | Feb 6, 2018 | Dec 21, 2020 | Jan 5, 2021 | 27 | China, South Korea +1 |
Clinical and endoscopy response (decrease from Baseline in full Mayo score ≥3 and ≥30%, including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore ≤1) at Week 12.
| Arm | Type | Description |
|---|---|---|
| TJ301 300mg | EXPERIMENTAL | TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
| TJ301 600mg | EXPERIMENTAL | TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
| Placebo | PLACEBO_COMPARATOR | Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
| Name | Type | Description |
|---|---|---|
| TJ301 300mg | DRUG | TJ301 300mg IV infusion |
| TJ301 600mg | DRUG | TJ301 600mg IV infusion |
| Placebo | DRUG | Placebo IV infusion |
Inclusion Criteria: 1. Male and female patients 18-70 (inclusive) years of age. 2. Hisory of active UC of more than 3 months. Active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending \> 15-cm past the anal verge from endoscopy. Biopsy sample ...