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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05668013 | A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | PHASE2 | ACTIVE NOT_RECRUITING | 247 | — | — | Jan 11, 2023 | Mar 8, 2031 | May 20, 2026 | 93 | United States, Austria +14 |
Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: * stool frequency subscore of 0 or 1, * rectal bleeding subscore of 0, and * endoscopic subscore of 0 or 1, where a score of 1 does not include "friability"
Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD
| Arm | Type | Description |
|---|---|---|
| TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574 Dose Regimen A for Crohn's Disease (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574 Dose Regimen B for Ulcerative Colitis (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574 Dose Regimen B for Crohn's Disease (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| Name | Type | Description |
|---|---|---|
| TEV-48574 Dose Regimen A | DRUG | Subcutaneous (sc) administration using a commercial sc infusion system |
| TEV-48574 Dose Regiment B | DRUG | Subcutaneous (sc) administration using a commercial sc infusion system |
Inclusion Criteria: * Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. * Re-induction- Participants who did not achieve clinical response and/or clinical rem...