Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SBI-087 · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | - |
| Treatment Group 2 | EXPERIMENTAL | - |
| Treatment Group 3 | EXPERIMENTAL | - |
| Treatment Group 4 | EXPERIMENTAL | - |
| Treatment Group 5 | PLACEBO_COMPARATOR | - |
| SBI-087 | EXPERIMENTAL | - |
| SBI-087 0.15 mg IV | EXPERIMENTAL | - |
| SBI-087 0.5 mg IV | EXPERIMENTAL | - |
| SBI-087 100 mg SC | EXPERIMENTAL | - |
| SBI-087 200 mg SC | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | SBI-087 |
| Name | Type | Description |
|---|---|---|
| SBI-087 | DRUG | 200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
| Placebo | DRUG | Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
Inclusion Criteria: * Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-r...
SBI-087 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis and systemic lupus erythematosus. It has been evaluated in clinical trials in patients with these autoimmune and inflammatory conditions. It is not an approved therapy and remains in clinical development.
SBI-087 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trial program evaluating the compound in rheumatoid arthritis and systemic lupus erythematosus.
SBI-087 has reached Phase 2 clinical development. A Phase 2 study evaluated the efficacy and safety of SBI-087 in seropositive subjects with active rheumatoid arthritis. Earlier Phase 1 studies were also conducted in rheumatoid arthritis and systemic lupus erythematosus. The drug is investigational and has not been approved by the FDA.
SBI-087 has been studied in completed trials including NCT01008852, a Phase 2 trial in active rheumatoid arthritis that enrolled 210 patients, and NCT00815906, a Phase 1 single-dose study in Japanese subjects with rheumatoid arthritis. Phase 1 trials NCT00714116 in systemic lupus erythematosus and NCT00641225 in rheumatoid arthritis were also completed.
The Phase 2 trial NCT01008852 was a randomized, double-blind, placebo-controlled study of SBI-087 in seropositive subjects with active rheumatoid arthritis. It enrolled 210 participants aged 18 years and older across the United States, Argentina, Canada, Chile, Hungary, Japan, Mexico, Poland, Serbia, and Spain. The study is completed.