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Also known as GLPG0259 solution, GLPG0259 fumarate, GLPG0259 free base, GLPG0259 oral capsule
GLPG0259 · 1 trial · 1 indication
The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
| Arm | Type | Description |
|---|---|---|
| GLPG0259 (Part A) | EXPERIMENTAL | - |
| Placebo (Part A) | PLACEBO_COMPARATOR | - |
| GLPG0259 (Part B) | EXPERIMENTAL | - |
| Placebo (Part B) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GLPG0259 oral capsule | DRUG | Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule) |
| Placebo | DRUG | Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule |
| GLPG0259 (Part B) | DRUG | Capsule, dosage to be established based on results of Part A |
| Placebo (Part B) | DRUG | Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B) |
Inclusion Criteria: * Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL). * Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study; * If on...
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GLPG0259 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in a Phase 2 trial in patients with methotrexate-refractory rheumatoid arthritis, meaning patients whose disease had not responded adequately to methotrexate. It is not approved for any indication and remains in clinical development.
GLPG0259 targets MAPKAPK5, also known as MK5, and acts as an inhibitor of this enzyme. MAPKAPK5 is a kinase involved in cellular stress and inflammatory signaling pathways, which is the rationale for testing the compound in an immune-mediated condition such as rheumatoid arthritis.
GLPG0259 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is the sponsor of the clinical program evaluating the compound in rheumatoid arthritis.
GLPG0259 is in Phase 2 development. One Phase 2 trial has been completed, and there are currently no active trials of the drug. It is an investigational agent and is not approved by the FDA or any other regulatory authority for rheumatoid arthritis or any other indication.
GLPG0259 has been studied in one completed Phase 2 trial, NCT01211249, titled "GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis." The trial enrolled 30 patients across Belgium, the Netherlands, Poland, Russia, and Ukraine. It was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.
GLPG0259 fumarate, GLPG0259 free base, GLPG0259 solution, and GLPG0259 oral capsule all refer to the same investigational compound, GLPG0259. These names describe different salt forms, formulations, or presentations of the drug rather than separate products. The active molecule studied in rheumatoid arthritis is GLPG0259.