Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-8690
PRA052 · 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 ...
PRA052 is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK). It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease or condition PRA052 is intended to treat has not been disclosed.
PRA052 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck sponsored the Phase 1 study of PRA052 conducted in the United States. No partnership or licensing arrangement for PRA052 has been disclosed.
PRA052 is in Phase 1 clinical development. One Phase 1 trial, NCT05603182, has been completed. The study enrolled 96 healthy adult volunteers and was randomized, double-blind, and placebo-controlled. PRA052 is investigational and has not been approved by the FDA.
PRA052 has been evaluated in one clinical trial, NCT05603182, titled A Study of PRA052 in Healthy Volunteers. The Phase 1 trial was completed and enrolled 96 participants in the United States. It was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
PRA052 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, and its only completed trial, NCT05603182, studied it in healthy volunteers. Merck & Company, Inc. (ticker MRK) is the developer.