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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07012395 | A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis | PHASE2 | RECRUITING | 645 | — | — | May 27, 2025 | Mar 1, 2028 | Jun 8, 2026 | 223 | United States, Argentina +32 |
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.
| Arm | Type | Description |
|---|---|---|
| Intervention Specific Appendix - SPY001: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY001 |
| Intervention Specific Appendix - SPY002: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY002 |
| Intervention Specific Appendix - SPY003: Part A | EXPERIMENTAL | Participants will receive open-label dose of SPY003 |
| Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY001 |
| Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY001 |
| Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY002 |
| Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY002 |
| Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 1 of SPY003 |
| Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part B | EXPERIMENTAL | Participants will receive double-blind dosing regimen 2 of SPY003 |
| Intervention Specific Appendix - SPY120: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY001 and SPY002 |
| Intervention Specific Appendix - SPY130: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY001 and SPY003 |
| Intervention Specific Appendix - SPY230: Part B | EXPERIMENTAL | Participants will receive double-blind dose of SPY002 and SPY003 |
| Placebo: Part B | PLACEBO_COMPARATOR | Participants will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| SPY001 | DRUG | Experimental |
| SPY002 | DRUG | Experimental |
| SPY003 | DRUG | Experimental |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) * ...