Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
firategrast · 2 trials · 1 indication
Total leukocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. CSF sample data presented are results from the local clinical laboratory.
Total leukocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. CSF sample data presented are results from the local clinical laboratory. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Total leukocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. Blood sample data presented are results from the independent assessor.
Total leukocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. Blood sample data presented are results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Total lymphocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Total lymphocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Total lymphocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Total lymphocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD4 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD4 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD4 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD4 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD8 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD8 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD8 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD8 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD4:CD8 ratio in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD4:CD8 ratio in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
The count for CD4:CD8 ratio in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
The count for CD4:CD8 ratio in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| firategrast | EXPERIMENTAL | 900 (females) or 1200 (males) mg twice daily for 24 weeks |
| Arm 1 | PLACEBO_COMPARATOR | placebo (4 tablets) |
| Arm 2 | EXPERIMENTAL | SB-683699 150 mg bid (1 x 150mg + 3 placebo tablets) |
| Arm 3 | EXPERIMENTAL | SB-683699 600 mg bid (2 x 300mg + 2 placebo tablets) |
| Arm 4 | EXPERIMENTAL | SB-683699 900 mg bid (3 x 300 mg + 1 placebo tablet) |
| Arm 5 | EXPERIMENTAL | SB-683699 1200 mg bid, male subjects only (4 x 300 mg tablets) |
| Name | Type | Description |
|---|---|---|
| firategrast | DRUG | 900 (females) or 1200 (males) mg twice daily for 24 weeks |
| Placebo | OTHER | placebo tablet |
| Firategrast 150 mg | DRUG | 150 mg tablet |
| Firategrast 300 mg | DRUG | 300 mg tablet |
Inclusion criteria: Specific information regarding warnings, precautions, contraindications, adverse events (AEs), and other pertinent information on the investigational product that may impact subject eligibility is provided can be found in the SB-683699 Investigators Brochure \[GlaxoSmithKline Do...
Firategrast is an investigational small molecule being studied for the treatment of multiple sclerosis (MS). It has been evaluated in Phase 2 clinical trials in patients with relapsing-remitting multiple sclerosis and other relapsing forms of the disease. Firategrast is not approved and remains in clinical development.
Firategrast is a small molecule that targets alpha-4 integrin, a protein involved in the migration of white blood cells into the central nervous system. By blocking this target, firategrast is intended to reduce inflammation and damage associated with multiple sclerosis. This mechanism was studied in clinical trials for relapsing forms of MS.
Firategrast is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. GSK sponsored the Phase 2 clinical trials of firategrast in multiple sclerosis. The drug is investigational and has not been approved by regulatory authorities.
Firategrast is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total enrollment of 389 participants. Both trials were randomized, double-blind, and placebo-controlled, studying firategrast in patients with multiple sclerosis. Firategrast is not FDA approved and remains an investigational drug.
Firategrast has been studied in two completed Phase 2 clinical trials. NCT00395317 enrolled 343 participants with relapsing-remitting multiple sclerosis across multiple countries. NCT00469378 enrolled 46 participants with relapsing forms of multiple sclerosis to study white blood cells in cerebrospinal fluid and blood. Both trials are completed.
Firategrast is also known as SB-683699, as indicated by the clinical trial title for NCT00395317, which studied SB-683699 compared to placebo in subjects with relapsing-remitting multiple sclerosis. This alternative name may appear in scientific literature and trial registries, referring to the same investigational drug.