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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GS-0151 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adult participants with rheumatoid arthritis.
GS-0151 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the safety and efficacy of GS-0151 in patients with rheumatoid arthritis.
GS-0151 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 study is currently active but not recruiting participants, with an enrollment target of 65 participants.
GS-0151 is being evaluated in a Phase 1 clinical trial with the identifier NCT06902519. This study is titled "Study of GS-0151 in Participants With Rheumatoid Arthritis" and is active but not recruiting. The trial is randomized, double-blind, and placebo-controlled, enrolling participants in the United States, Georgia, Germany, Moldova, Poland, and Spain.
Yes, GS-0151 is being studied in a randomized, double-blind, placebo-controlled Phase 1 trial. This design helps researchers compare the effects of GS-0151 against a placebo to assess its safety and tolerability in participants with rheumatoid arthritis.