Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

Gilead Sciences

Status and phase: Withdrawn; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: GS-5718; Drug: Placebo to match GS-5718; Drug: Placebo to match Tofacitinib; Drug: Tofacitinib 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05165771

2021-002664-52 (EudraCT Number)

GS-US-561-5898

Details and patient eligibility

About

The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28[CRP]) at Week 12.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA

• Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity

• Individual fulfills all of the following minimum disease activity criteria:

  • ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints [SJC28]) at screening and Day 1, and
  • ≥ 6 tender joints (from a tender joint count based on 68 joints [TJC68]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints [TJC28]) at screening and Day 1, and
  • hsCRP > upper limit of normal at screening

• Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.

Key Exclusion Criteria:

• Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
• Prior exposure to any Janus kinase inhibitor

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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0 participants in 4 patient groups, including a placebo group

GS-5718 Dose A

Experimental group

Description:

Participants will receive GS-5718 Dose A once daily + placebo to match (PTM) GS-5718 Dose B once daily + PTM tofacitinib twice daily for up to 12 weeks.

Treatment:

Drug: Placebo to match Tofacitinib

Drug: GS-5718

Drug: Placebo to match GS-5718

Drug: GS-5718

GS-5718 Dose B

Experimental group

Description:

Participants will receive GS-5718 Dose B once daily + PTM GS-5718 Dose A once daily + PTM tofacitinib twice daily for up to 12 weeks.

Treatment:

Drug: Placebo to match Tofacitinib

Drug: GS-5718

Drug: Placebo to match GS-5718

Drug: GS-5718

Tofacitinib

Active Comparator group

Description:

Participants will receive tofacitinib 5 mg twice daily + PTM GS-5718 (Dose A + Dose B) once daily for up to 12 weeks.

Treatment:

Drug: Tofacitinib 5 mg

Drug: Placebo to match GS-5718

Placebo

Placebo Comparator group

Description:

Participants will receive PTM GS-5718 (Dose A + Dose B) once daily + PTM tofacitinib twice daily for up to 12 weeks.

Treatment:

Drug: Placebo to match Tofacitinib

Drug: Placebo to match GS-5718