Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PRA052
MK-8690 · 2 trials · 3 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.
Incidence, severity, and causal relationship of TEAEs
| 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. |
| SAD Cohorts 1-8 Experimental Arm | EXPERIMENTAL | Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format |
| SAD Cohorts 1-8 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive a single intravenous or subcutaneous dose of placebo |
| MAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks |
| Name | Type | Description |
|---|---|---|
| MK-8690 | DRUG | Solution for subcutaneous injection |
| Placebo | OTHER | Solution for subcutaneous injection |
| PRA052 | DRUG | PRA052 |
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 studied for the treatment of moderately to severely active ulcerative colitis, a form of inflammatory bowel disease. It is not yet approved for any use and remains in clinical development. Merck is evaluating it in adults aged 18 and older.
MK-8690 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in ulcerative colitis.
MK-8690 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 study is currently recruiting participants.
MK-8690 is being studied in one active clinical trial, NCT07463183, titled a study to evaluate efficacy and safety of MK-8690 in participants with moderately to severely active ulcerative colitis. The Phase 2 trial is recruiting, is randomized, double blind, and placebo controlled, and plans to enroll 100 participants across the United States, Canada, Colombia, France, Germany, Greece, Italy, the Netherlands, Poland, South Korea, and the United Kingdom.
Yes. The Phase 2 trial of MK-8690, NCT07463183, is a randomized, double blind, placebo controlled study. Participants with moderately to severely active ulcerative colitis are assigned to MK-8690 or placebo, and the study plans to enroll approximately 100 participants aged 18 years and older.