Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-0151 · 1 trial · 1 indication
AUCtau is defined as the area under the serum concentration versus time curve over the dosing interval.
Cmax is defined as the maximum observed plasma drug concentration.
Tmax is defined as the time (observed time point) of Cmax.
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort 1 (GS-0151 Dose A) | EXPERIMENTAL | Participants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks. |
| Part A: Cohort 1 (Placebo) | PLACEBO_COMPARATOR | Participants with RA will be randomized to receive placebo up to 12 weeks. |
| Part A: Cohort 2 (GS-0151 Dose B) | EXPERIMENTAL | Participants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks. |
| Part A: Cohort 2 (Placebo) | PLACEBO_COMPARATOR | Participants with RA will be randomized to receive placebo up to 12 weeks. |
| Part B: Cohort 3 (GS-0151 Dose C) | EXPERIMENTAL | Participants with moderately to severely active RA will be randomized to receive Dose C of GS-0151. |
| Part B: Cohort 3 (Placebo) | PLACEBO_COMPARATOR | Participants with moderately to severely active RA will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| GS-0151 | DRUG | Administered for 12 weeks |
| Placebo | DRUG | Administered for 12 weeks |
Key Inclusion Criteria: Medical History/Physical Characteristics; All Cohorts: * Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the e...
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