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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07186101 | LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: | PHASE2 | RECRUITING | 252 | — | — | Nov 10, 2025 | Mar 1, 2029 | Jun 4, 2026 | 150 | United States, Austria +15 |
The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability
| Arm | Type | Description |
|---|---|---|
| LY4268989 + Mirikizumab | EXPERIMENTAL | LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. |
| Mirikizumab + LY4268989 Placebo | EXPERIMENTAL | Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. |
| Name | Type | Description |
|---|---|---|
| LY4268989 | DRUG | Administered PO |
| Mirikizumab | DRUG | Administered IV then SC |
| LY4268989 Placebo | DRUG | Administered PO |
Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC * Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by centra...