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Also known as P38 Inhibitor (4)
P38 Inhibitor · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| P38 Inhibitor (4) 150mg | EXPERIMENTAL | - |
| P38 Inhibitor (4) 25mg | EXPERIMENTAL | - |
| P38 Inhibitor (4) 300mg | EXPERIMENTAL | - |
| P38 Inhibitor (4) 50mg | EXPERIMENTAL | - |
| P38 Inhibitor (4) 75mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| P38 Inhibitor (4) | DRUG | 50mg po qd |
| Placebo | DRUG | po qd |
| P38 Inhibitor (4) 150mg | DRUG | 150mg po qd |
| P38 Inhibitor (4) 25mg | DRUG | 25mg po bid |
| P38 Inhibitor (4) 300mg | DRUG | 300mg po qd |
| P38 Inhibitor (4) 50mg | DRUG | 50mg po qd |
| P38 Inhibitor (4) 75mg | DRUG | 75mg po bid |
Inclusion Criteria: * adult patients \>18 years of age, with active RA; * receiving treatment for RA on an outpatient basis; * females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the stud...
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P38 Inhibitor is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It has been evaluated both as monotherapy and in combination with stable methotrexate therapy in adults with active RA. It is not described as an approved therapy and remains in clinical development.
P38 Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical program evaluating this small molecule in rheumatoid arthritis, including two Phase 2 studies conducted across multiple countries in North America, Europe, Latin America, Asia, and Australia.
P38 Inhibitor is in Phase 2 development. Two Phase 2 trials in rheumatoid arthritis have been completed, and no trials are currently listed as active. The program has enrolled 578 participants in total across those completed studies.
P38 Inhibitor has been studied in two completed Phase 2 trials. NCT00316771 evaluated P38 Inhibitor (4) in patients with active rheumatoid arthritis on stable methotrexate therapy and enrolled 374 participants. NCT00303563 evaluated P38 Inhibitor (4) monotherapy in patients with active rheumatoid arthritis and enrolled 204 participants.
Both P38 Inhibitor trials were randomized, double-blind, and placebo-controlled Phase 2 studies in adults with active rheumatoid arthritis. NCT00316771 tested the drug alongside stable methotrexate therapy, while NCT00303563 tested monotherapy. Participants were 18 years or older, and the studies enrolled patients across multiple countries.
Yes. P38 Inhibitor is also referred to as P38 Inhibitor (4) and P38 Inhibitor (4) 150mg. These names appear in the trial titles for the two completed Phase 2 rheumatoid arthritis studies, NCT00316771 and NCT00303563, and refer to the same Roche small molecule compound.