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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06290934 | Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis | PHASE2 | ACTIVE NOT_RECRUITING | 228 | — | — | Mar 27, 2024 | Apr 1, 2028 | Apr 9, 2026 | 181 | United States, Australia +20 |
Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1. The mMCS is a scoring system for assessment of Ulcerative Colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.
| Arm | Type | Description |
|---|---|---|
| Part A, Part B, Part C: Emvistegrast Dose A | EXPERIMENTAL | Participants will receive emvistegrast Dose A Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116). |
| Part A, Part B, Part C: Emvistegrast Dose B | EXPERIMENTAL | Participants will receive emvistegrast Dose B Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116). |
| Part A, Part B, Part C: Emvistegrast Dose C | EXPERIMENTAL | Participants will receive emvistegrast Dose C Day 1 through Week 12 (Part A). Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 64 weeks (through Week 116). |
| Part A, Placebo; Part B, Part C: Emvistegrast | EXPERIMENTAL | Participants will receive Placebo to match emvistegrast Day 1 through Week 12 (Part A). Part A placebo participants will be eligible to undergo re-randomization in a double-blind manner after endoscopy assessment at Week 12 to receive one of the emvistegrast dose A, B, or C treatments. Participants will be eligible to continue and remain on the new dose through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 64 weeks (through Week 116). |
| Name | Type | Description |
|---|---|---|
| emvistegrast | DRUG | Administered orally |
| Placebo-to-match emvistegrast | DRUG | Administered orally |
Key Inclusion Criteria: * Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of U...