Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8690 · 1 trial · 2 indications
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 ...
MK-8690 is an investigational small molecule being developed for the treatment of moderately to severely active ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MK-8690 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 2 clinical trial to evaluate the drug's efficacy and safety in patients with ulcerative colitis.
MK-8690 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is actively recruiting participants with moderately to severely active ulcerative colitis.
MK-8690 is being studied in one active Phase 2 clinical trial, identified as NCT07463183. This randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of MK-8690 in approximately 100 participants with moderately to severely active ulcerative colitis across multiple countries.
No, MK-8690 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for ulcerative colitis. The ongoing study, NCT07463183, is recruiting participants to evaluate the drug's efficacy and safety, but regulatory approval has not been granted.