Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: GS-9876 placebo; Drug: Filgotinib placebo; Drug: Filgotinib; Drug: GS-9876; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02885181

GS-US-379-1582

2016-001496-75 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.

Enrollment: 83 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 12 weeks
• No evidence of active or latent tuberculosis

Key Exclusion Criteria:

• Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
• Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
• Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
• Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 4 patient groups, including a placebo group

GS-9876 - 30 mg

Experimental group

Description:

GS-9876 30 mg + filgotinib placebo for 12 weeks

Treatment:

Drug: Filgotinib placebo

Drug: GS-9876

Drug: Methotrexate

GS-9876 - 10 mg

Experimental group

Description:

GS-9876 10 mg + filgotinib placebo for 12 weeks

Treatment:

Drug: Filgotinib placebo

Drug: GS-9876

Drug: Methotrexate

Filgotinib

Experimental group

Description:

Filgotinib + GS-9876 placebo for 12 weeks

Treatment:

Drug: Filgotinib

Drug: Methotrexate

Drug: GS-9876 placebo

Placebo

Placebo Comparator group

Description:

GS-9876 placebo + filgotinib placebo for 12 weeks

Treatment:

Drug: Filgotinib placebo

Drug: Methotrexate

Drug: GS-9876 placebo