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Also known as MK-0873
MK-0873 Patch · 2 trials · 2 indications
Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.
Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
| Arm | Type | Description |
|---|---|---|
| MK-0873 | EXPERIMENTAL | MK-0873 1.25 mg twice daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks |
| Panel A - MK-0873 5.1 mg | EXPERIMENTAL | In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days. |
| Panel A - Placebo | PLACEBO_COMPARATOR | In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days. |
| Panel B - MK-0873 25 mg | EXPERIMENTAL | In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days. |
| Panel B - Placebo | PLACEBO_COMPARATOR | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| Panel C - MK-0873 100 mg | EXPERIMENTAL | In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days. |
| Panel C - Placebo | PLACEBO_COMPARATOR | In Part II, healthy participants received skin application of placebo cream once daily for 10 days. |
| Panel D - MK-0873 200 mg | EXPERIMENTAL | In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days. |
| Panel D - Placebo | PLACEBO_COMPARATOR | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| Panel E and Extension - MK-0873 200 mg | EXPERIMENTAL | In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days. |
| Panel E and Extension - Placebo | PLACEBO_COMPARATOR | In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days. |
| Name | Type | Description |
|---|---|---|
| MK-0873 | DRUG | MK-0873 1.25 mg twice daily for 12 weeks |
| Comparator: Placebo | DRUG | Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks |
| MK-0873 Patch | DRUG | MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873 |
| MK-0873 Cream | DRUG | MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873 |
| Placebo Patch | DRUG | Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches |
| Placebo Cream | DRUG | Placebo cream matching MK-0873 0.05%, 0.5%, or 2% |
| Plain patch | DRUG | Plain patch containing no MK-0873 or placebo |
Inclusion Criteria: * Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications * Other criteria also apply Exclusion Criteria: * Other major illnesses * Past history of certain other disorders * Certain prohibited medication...
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MK-0873 Patch is an investigational small molecule being studied for plaque psoriasis and rheumatoid arthritis. The patch formulation was evaluated in a Phase 1 trial in healthy participants and participants with plaque psoriasis. It is not approved for any indication and remains in clinical development.
MK-0873 targets phosphodiesterase 4 (PDE4), specifically the PDE4A, PDE4B, PDE4C, and PDE4D subtypes. It acts as a PDE4 inhibitor. Inhibiting PDE4 raises intracellular cyclic AMP levels, which is the proposed mechanism behind its anti-inflammatory activity in immune-mediated conditions such as psoriasis and rheumatoid arthritis.
MK-0873 Patch is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the clinical trials evaluating the patch formulation in plaque psoriasis and an earlier study of the drug in rheumatoid arthritis.
MK-0873 Patch is in Phase 1 development. A Phase 1 trial assessed its safety, tolerability, and pharmacokinetics after patch application in healthy participants and participants with plaque psoriasis. The drug is investigational and has not been approved by the FDA for any indication.
MK-0873 Patch was studied in the completed Phase 1 trial NCT01140061, which evaluated safety, tolerability, and pharmacokinetics after patch application in healthy participants and psoriasis participants and enrolled 42 people. A separate completed Phase 2 trial, NCT00132769, tested the drug in 106 rheumatoid arthritis patients.
Yes. MK-0873 Patch is the patch formulation of MK-0873, and both names refer to the same investigational compound. The patch was designed for topical application, which is why the Phase 1 plaque psoriasis study used the patch format rather than another route of administration.