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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06226883 | A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease | PHASE2 | RECRUITING | 385 | — | — | Jul 18, 2024 | Jun 1, 2030 | Jun 4, 2026 | 226 | United States, Australia +26 |
| NCT05611671 | A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC | PHASE2 | ACTIVE NOT_RECRUITING | 280 | — | — | Nov 21, 2022 | Aug 1, 2026 | Dec 15, 2025 | 102 | United States, Australia +19 |
| NCT05291689 | A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC | PHASE2 | COMPLETED | 39 | — | — | Apr 13, 2022 | Feb 19, 2025 | Mar 11, 2026 | 17 | United States, Poland |
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
| Arm | Type | Description |
|---|---|---|
| Group 1 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 2 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 3 (Part A) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 4 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 5 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 6 (Part B) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| MORF-057 200 mg BID | EXPERIMENTAL | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. |
| MORF-057 100 mg BID | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
| MORF-057 100 mg QD-M | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received an oral dose of matching placebo for 12 weeks. |
| MORF-057 | EXPERIMENTAL | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo (identical appearance to MORF-057) administered orally. |
| MORF-057 | DRUG | MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
Key Inclusion Criteria: * Has signs/symptoms of CD for at least 90 days prior to screening * Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points * Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is iso...