| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05499130 | A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease | PHASE2 | COMPLETED | 290 | — | — | Sep 30, 2022 | Nov 12, 2024 | Mar 27, 2026 | 164 | United States, Austria +17 |
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.
| Arm | Type | Description |
|---|---|---|
| TEV-48574, 450 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 900 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 1800 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03. |
| TEV-48574, 450 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 900 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 1800 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03. |
| Placebo UC | PLACEBO_COMPARATOR | Matching Placebo |
| Placebo CD | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| TEV-48574 | DRUG | Subcutaneous infusion |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: * Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months * The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study * The participant is able to understand the nature of ...