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RWJ-445380 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RWJ-445380 100 mg | EXPERIMENTAL | - |
| RWJ-445380 200 mg | EXPERIMENTAL | - |
| RWJ-445380 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RWJ-445380 100 mg | DRUG | RWJ-445380 100 mg once daily for up to 12 weeks |
| RWJ-445380 200 mg | DRUG | RWJ-445380 200 mg once daily for up to 12 weeks |
| RWJ-445380 300 mg | DRUG | RWJ-445380 300 mg once daily for up to 12 weeks |
| Placebo | DRUG | Placebo once daily for up to 12 weeks |
Inclusion Criteria: * Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints * methotrexate treatment for 6 months * at least 10mg/wk and stable dose for at least 8 weeks * negative TB screening Exclusion Criteria: * Use of other disease-mod...
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RWJ-445380 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis in adults. It was evaluated in patients whose disease remained active despite methotrexate therapy. It is not an approved therapy and remains in clinical development for this immunology indication.
RWJ-445380 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is a small molecule cathepsin-S inhibitor that the company advanced into mid-stage clinical testing in rheumatoid arthritis.
RWJ-445380 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently listed as active. The program has not been approved by the FDA, so RWJ-445380 remains an investigational drug rather than an available treatment option.
RWJ-445380 was studied in the Phase 2 trial NCT00425321, titled a safety and effectiveness study of RWJ-445380 cathepsin-S inhibitor in patients with active rheumatoid arthritis despite methotrexate therapy. That randomized, double-blind, placebo-controlled trial enrolled 259 patients across the United States, Argentina, Brazil, Czechia, Germany, Mexico and Poland, and it is now completed.
RWJ-445380 is a small molecule cathepsin-S inhibitor. Cathepsin S is a protease involved in antigen processing and immune signaling, and inhibiting it is the intended mechanism for reducing the inflammatory processes that drive rheumatoid arthritis. The compound was tested as an oral small molecule in patients with active disease.