Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PH-797804 · 7 trials · 5 indications
ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.
| Arm | Type | Description |
|---|---|---|
| PH-787904 (arm1) | EXPERIMENTAL | - |
| PH-787904 (arm2) | EXPERIMENTAL | - |
| PH-787904 (arm3) | EXPERIMENTAL | - |
| PH-787904 (arm4) | EXPERIMENTAL | - |
| PH-787904 (arm5) | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| PH-797804 | EXPERIMENTAL | - |
| Treatment Sequence 1 | OTHER | - |
| Treatment Sequence 2 | OTHER | - |
| Treatment Sequence 3 | OTHER | - |
| Treatment Sequence 4 | OTHER | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PH-797804 | DRUG | 0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
| Placebo | DRUG | Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
| Naproxen | DRUG | Tablet, 500 mg twice daily for 2 weeks |
| Naproxen + PH-797804 | DRUG | Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks |
Inclusion Criteria: * Male or female subjects between, and including, the ages of 40 and 80 years. * Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio \<0.7 ...
PH-797804 is an investigational small molecule drug developed by Pfizer, Inc. (ticker PFE) for immunology indications. It has been studied in Phase 2 clinical trials for chronic obstructive pulmonary disease, osteoarthritis of the knee, and rheumatoid arthritis. It is not approved and remains in clinical development.
PH-797804 targets MAPK14, also known as p38 alpha mitogen-activated protein kinase. It acts as an inhibitor of this enzyme. MAPK14 is involved in inflammatory signaling pathways, which is the rationale for studying PH-797804 in inflammatory and pain-related conditions such as COPD, osteoarthritis, and rheumatoid arthritis.
PH-797804 has been studied in Phase 2 trials for moderate to severe chronic obstructive pulmonary disease, osteoarthritis of the knee, and rheumatoid arthritis. It has also been associated with postherpetic neuralgia. All studies are complete, and the drug is investigational rather than an approved treatment.
PH-797804 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 2 clinical program evaluating the compound across respiratory, joint, and inflammatory indications.
PH-797804 is in Phase 2. Four Phase 2 trials have been completed, including studies in COPD, osteoarthritis of the knee, and rheumatoid arthritis. No active trials are ongoing, and the drug is investigational, meaning it is not approved for any indication.
Completed Phase 2 trials include NCT01543919 and NCT01321463 in moderate to severe COPD, NCT01102660 in osteoarthritis of the knee, and NCT00620685 in rheumatoid arthritis patients taking methotrexate. These randomized, double-blind, placebo-controlled studies enrolled a combined total of 1,306 participants across multiple countries.