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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03695185 | A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | PHASE2 | COMPLETED | 42 | — | — | Mar 26, 2019 | Jan 10, 2022 | Mar 15, 2023 | 34 | United States, Canada +8 |
Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
| Arm | Type | Description |
|---|---|---|
| Ravagalimab 600 mg/300 mg | EXPERIMENTAL | Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. |
| Name | Type | Description |
|---|---|---|
| Ravagalimab 600 mg | DRUG | Ravagalimab 600 mg was administered intravenously (IV). |
| Ravagalimab 300 mg | DRUG | Ravagalimab 300 mg was administered subcutaneously (SC). |
Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. * Diagnosis of UC for at least 3 months prior to Baseline...