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Monoclonal Antibodies

GS-0272 for Rheumatoid Arthritis and Lupus (MARASLE Trial)

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.

Individuals must not be on a biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 predose through day 197

Summary

This trial looks at the safety & tolerability of a drug (GS-0272) for RA & SLE patients, & how it affects their bodies.

Who is the study for?

This trial is for adults with Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE). RA patients must have been diagnosed at least 3 months ago and on stable csDMARDs, not b/tsDMARDs. SLE patients need a diagnosis from at least 24 weeks prior and stable nonbiologic treatments. Those with certain infections or highly active SLE are excluded.

What is being tested?

The study tests GS-0272's safety and how the body processes it after multiple doses in RA and SLE patients. Participants will receive either GS-0272 or a placebo through subcutaneous injections to compare effects.

What are the potential side effects?

While specific side effects of GS-0272 aren't listed, common ones for arthritis medications include injection site reactions, upper respiratory infections, headaches, nausea, and potential increases in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with RA more than 3 months ago, according to ACR/EULAR criteria.

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I am not taking specific arthritis drugs and haven't for the last 4 weeks (or 16 weeks for rituximab).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 predose through day 197

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 predose through day 197

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 predose through day 197 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK of GS-0272: Cmax

PK of GS-0272: Tmax

Pharmacokinetics (PK) of GS-0272: AUCtau

Secondary study objectives

Incidence of ADAs for GS-0272

Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA

Prevalence of Antidrug Antibodies (ADAs) for GS-0272

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Active RA Cohort: GS-0272 or PlaceboExperimental Treatment2 Interventions

Part B will include participants with moderate-to-severe RA. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 2:1 ratio to receive either GS-0272 or placebo for 12 weeks.

Group II: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or PlaceboExperimental Treatment2 Interventions

Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks. Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met