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GS-9876

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Gilead Sciences, Inc.|Last Updated: Sep 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

GS-9876 · 1 trial · 1 indication

Phase 2 1
NCT02885181Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With MethotrexateRheumatoid Arthritis
COMPLETED83 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
Baseline; Week 12

Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

Secondary Endpoints

Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
Week 12
Percentage of Participants Who Achieved ACR50 Improvement at Week 12
Week 12
Percentage of Participants Who Achieved ACR70 Improvement at Week 12
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GS-9876 - 30 mgEXPERIMENTALGS-9876 30 mg + filgotinib placebo for 12 weeks
GS-9876 - 10 mgEXPERIMENTALGS-9876 10 mg + filgotinib placebo for 12 weeks
FilgotinibEXPERIMENTALFilgotinib + GS-9876 placebo for 12 weeks
PlaceboPLACEBO_COMPARATORGS-9876 placebo + filgotinib placebo for 12 weeks

Interventions

NameTypeDescription
GS-9876DRUGOne tablet administered orally once daily
FilgotinibDRUGTwo tablets administered orally once daily
GS-9876 placeboDRUGOne tablet administered orally once daily
Filgotinib placeboDRUGTwo tablets administered orally once daily
MethotrexateDRUGBackground therapy with methotrexate administered orally or parenterally once weekly
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Key Inclusion Criteria: * Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1 * Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 1...

Countries:United StatesBulgariaCzechiaGeorgiaMoldovaPolandUkraine
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Frequently asked questions about GS-9876

What is GS-9876 used for in rheumatoid arthritis?

GS-9876 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It is designed to be used in combination with background methotrexate therapy. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does GS-9876 target?

GS-9876 is a small molecule developed by Gilead Sciences for rheumatoid arthritis. While its specific molecular target is not publicly disclosed in the available clinical trial information, it is being evaluated for its safety, tolerability, and efficacy in patients with active disease who are on background methotrexate therapy.

Who makes GS-9876?

GS-9876 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's potential as a treatment for rheumatoid arthritis.

What phase is GS-9876 in?

GS-9876 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to assess its safety, tolerability, and efficacy in participants with active rheumatoid arthritis. The drug remains investigational and is not yet approved for any use.

What clinical trials is GS-9876 in?

GS-9876 has been studied in one completed Phase 2 clinical trial, identified as NCT02885181. This randomized, double-blind, placebo-controlled trial enrolled 83 participants with active rheumatoid arthritis on background methotrexate therapy, across multiple countries including the United States, Bulgaria, Czechia, Georgia, Moldova, Poland, and Ukraine.

Is GS-9876 the same as any other drug?

GS-9876 is the investigational code name used by Gilead Sciences for this small molecule. No alternative brand names or other designations have been disclosed in the clinical trial information. It is distinct from other drugs and is being evaluated specifically for rheumatoid arthritis.