Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAN-300/kg QW · 1 trial · 1 indication
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
| Arm | Type | Description |
|---|---|---|
| Cohort A - SAN-300 0.5 mg/kg QW | EXPERIMENTAL | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
| Cohort B - SAN-300 1.0 mg/kg QW | EXPERIMENTAL | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
| Cohort C - SAN-300 2.0 mg/kg QOW | EXPERIMENTAL | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| Cohort D - SAN-300 4.0 mg/kg QOW | EXPERIMENTAL | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Cohort E - SAN-300 4.0 mg/kg QW | EXPERIMENTAL | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo dosing |
| Name | Type | Description |
|---|---|---|
| SAN-300 0.5 mg/kg QW | DRUG | - |
| SAN-300 1.0 mg/kg QW | DRUG | - |
| SAN-300 2.0 mg/kg QOW | DRUG | - |
| SAN-300 4.0 mg/kg QOW | DRUG | - |
| SAN-300 4.0 mg/kg QW | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010 2. 18 to 75 years of age, inclusive, at the time of informed consent 3. Swollen joint count of ≥ 6 (66-joint count) and...
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SAN-300/kg QW is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in a Phase 2 clinical trial in adults with rheumatoid arthritis in the United States. It is not approved for any indication and remains in clinical development.
SAN-300/kg QW is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker BHC. The company sponsored the Phase 2 trial of the drug in rheumatoid arthritis.
SAN-300/kg QW is in Phase 2 development. A single Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
SAN-300/kg QW was studied in one completed Phase 2 trial, NCT02047604, titled Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis. The trial enrolled 41 adults in the United States and was randomized, double-blind, and placebo-controlled.