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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05570006 | Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis | PHASE2 | COMPLETED | 30 | — | — | Mar 16, 2023 | Dec 23, 2024 | Dec 23, 2025 | 30 | United States, Belgium +2 |
Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
| Arm | Type | Description |
|---|---|---|
| ABBV-668 | EXPERIMENTAL | Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-668 | DRUG | Oral Capsule |
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available. * Participant meets the following disease activity criteria: A...