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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07463183 | A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002) | PHASE2 | RECRUITING | 100 | — | — | Mar 24, 2026 | Dec 21, 2028 | May 26, 2026 | 8 | United States |
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
| Arm | Type | Description |
|---|---|---|
| Period 1: MK-8690 | EXPERIMENTAL | Participants will receive MK-8690 via subcutaneous injection for 12 weeks. |
| Period 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo via subcutaneous injection for 12 weeks. |
| Period 2: MK-8690 | EXPERIMENTAL | Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks. |
| Period 3: MK-8690 | EXPERIMENTAL | Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks. |
| Name | Type | Description |
|---|---|---|
| MK-8690 | DRUG | Solution for subcutaneous injection |
| Placebo | OTHER | Solution for subcutaneous injection |
The main inclusion criteria include but are not limited to the following: * Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization * Has moderately to severely active UC * Has a weight ≥40 kg * Satisfies at least 1 of the criteria: Has had an inadequate ...