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GS-0151

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Gilead Sciences, Inc.|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

GS-0151 · 1 trial · 1 indication

Phase 1 1
NCT06902519Study of GS-0151 in Participants With Rheumatoid ArthritisRheumatoid Arthritis
ACTIVE NOT_RECRUITING65 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of GS-0151 in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
First dose up to 19 Weeks post end of treatment at Week 12
Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
First dose up to 19 Weeks post end of treatment at Week 12
Cohorts 1, 2 and 3: Percentage of Participants Experiencing Serous Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Discontinuation
First dose up to 19 Weeks post end of treatment at Week 12
Cohort 1, 2 and 3: Serum AUCtau Following the Last Dose of GS-0151
Up to Week 12

AUCtau is defined as the area under the serum concentration versus time curve over the dosing interval.

Cohorts 1, 2 and 3: Serum Cmax, Following the Last Dose of GS-0151
Up to Week 12

Cmax is defined as the maximum observed plasma drug concentration.

Cohorts 1, 2 and 3: Serum Tmax Following the Last Dose of GS-0151
Up to Week 12

Tmax is defined as the time (observed time point) of Cmax.

Secondary Endpoints

Cohorts 1, 2, and 3: Percentage of Participants with Antidrug Antibodies (ADAs) During the Study
Up to Week 12
Cohort 3: Change From Baseline in Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28-CRP) at Week 12 in Participants With Moderately to Severely Active RA
Baseline, Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Cohort 1 (GS-0151 Dose A)EXPERIMENTALParticipants with RA will be randomized to receive Dose A of GS-0151 up to 12 weeks.
Part A: Cohort 1 (Placebo)PLACEBO_COMPARATORParticipants with RA will be randomized to receive placebo up to 12 weeks.
Part A: Cohort 2 (GS-0151 Dose B)EXPERIMENTALParticipants with RA will be randomized to receive Dose B of GS-0151 up to 12 weeks.
Part A: Cohort 2 (Placebo)PLACEBO_COMPARATORParticipants with RA will be randomized to receive placebo up to 12 weeks.
Part B: Cohort 3 (GS-0151 Dose C)EXPERIMENTALParticipants with moderately to severely active RA will be randomized to receive Dose C of GS-0151.
Part B: Cohort 3 (Placebo)PLACEBO_COMPARATORParticipants with moderately to severely active RA will be randomized to receive placebo.

Interventions

NameTypeDescription
GS-0151DRUGAdministered for 12 weeks
PlaceboDRUGAdministered for 12 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites35

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...

Countries:United StatesGeorgiaGermanyMoldovaPolandSpain
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Recent Changes (Last 90 Days)

MEDIUMSep 3, 2026NCT06902519Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 3, 2026NCT06902519Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 9, 2026NCT06902519lastUpdatePostDate: changed
LOWJun 9, 2026NCT06902519lastUpdatePostDate: changed
LOWJun 9, 2026NCT06902519lastUpdatePostDate: changed
LOWJun 9, 2026NCT06902519lastUpdatePostDate: changed

Frequently asked questions about GS-0151

What is GS-0151 used for?

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.

Who is developing GS-0151?

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.

What phase is GS-0151 in?

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.

What clinical trials is GS-0151 in?

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.

Is GS-0151 being studied in a placebo-controlled trial?

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.