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TAK-715 and methotrexate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TAK-715 25 mg BID | EXPERIMENTAL | - |
| TAK-715 50 mg BID | EXPERIMENTAL | - |
| TAK-715 100 mg BID | EXPERIMENTAL | - |
| Methotrexate | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-715 and methotrexate | DRUG | TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks. |
| Methotrexate | DRUG | TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks |
Inclusion Criteria: * Had a diagnosis of rheumatoid arthritis using American College of Rheumatology criteria of at least 6 months duration. * A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from ...
TAK-715 and methotrexate is an investigational combination being studied for the treatment of rheumatoid arthritis, a chronic inflammatory joint disease. TAK-715 is a small molecule developed by Takeda, and methotrexate is an established arthritis therapy used alongside it in this Phase 2 program.
TAK-715 targets MAPK14, also known as p38 alpha, a kinase involved in inflammatory signaling. It acts as an inhibitor of this target. By blocking MAPK14, the drug is designed to dampen the inflammatory pathways that drive rheumatoid arthritis symptoms.
Takeda Pharmaceutical Company Limited is developing TAK-715 and methotrexate. Takeda trades on the New York Stock Exchange under the ticker TAK. The company sponsored the Phase 2 rheumatoid arthritis study evaluating the combination.
TAK-715 and methotrexate is in Phase 2 development. The program has completed one Phase 2 clinical trial in rheumatoid arthritis. It is an investigational combination and has not been approved by the FDA for any indication.
TAK-715 and methotrexate was evaluated in the Phase 2 trial NCT00760864, titled Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis. The trial enrolled 432 adults, was randomized, double blind, and active controlled, and its status is completed.