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leflunomide · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 100 mg of leflunomide |
| 2 | ACTIVE_COMPARATOR | 20 mg of leflunomide |
| Name | Type | Description |
|---|---|---|
| leflunomide | DRUG | 20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months |
Inclusion Criteria: * Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines) * Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs) Exclusion Criteria: * Patient presenting or having a history of other inflammator...
Leflunomide is an investigational small molecule being studied for systemic lupus erythematosus (SLE) and rheumatoid arthritis. It is developed by Sanofi (SNY). Clinical trials have evaluated it in patients with these autoimmune conditions, with one completed Phase 2 trial in SLE and one completed Phase 3 trial in early rheumatoid arthritis.
Leflunomide is a small molecule immunomodulatory drug. It works by inhibiting dihydroorotate dehydrogenase, an enzyme involved in pyrimidine synthesis, which reduces proliferation of activated lymphocytes. This mechanism is relevant to autoimmune diseases like systemic lupus erythematosus and rheumatoid arthritis.
Leflunomide is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical development of Leflunomide for autoimmune indications including systemic lupus erythematosus and rheumatoid arthritis.
Leflunomide is in clinical development. A Phase 2 trial for systemic lupus erythematosus has been completed, and a Phase 3 trial for rheumatoid arthritis has also been completed. As of the available data, Leflunomide is not FDA approved and remains investigational.
Leflunomide has been studied in two completed clinical trials. NCT00596206 was a Phase 3 trial in early rheumatoid arthritis with 124 participants across Czechia, Italy, Portugal, Romania, and South Korea. NCT00637819 was a Phase 2 trial in systemic lupus erythematosus with 27 participants in Hong Kong.
Leflunomide is also known by the brand name Arava. It is the same drug substance, and clinical trials have used Leflunomide as the generic name. Arava is a marketed product for rheumatoid arthritis, while Leflunomide is being studied in additional indications.