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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07483099 | A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease | PHASE2 | RECRUITING | 60 | — | — | May 4, 2026 | Mar 1, 2028 | Jun 4, 2026 | 72 | United States, Belgium +8 |
The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.
| Arm | Type | Description |
|---|---|---|
| Mirikizumab | ACTIVE_COMPARATOR | Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC. |
| LY4395089 and Mirikizumab Co-Administration | EXPERIMENTAL | Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC. |
| Name | Type | Description |
|---|---|---|
| LY4395089 | DRUG | Administered orally |
| Mirikizumab - Intravenous (IV) | DRUG | Administered IV |
| Mirikizumab - Subcutaneous (SC) | DRUG | Administered SC |
Inclusion Criteria: Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below: * Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic ...